WO2025090885A1

WO2025090885A1 - Intra-operative exophthalmometer

Info

Publication number: WO2025090885A1
Application number: PCT/US2024/052989
Authority: WO
Inventors: Reza VAGEFI; Davin ASHRAF; Benjamin Liu; Bryan Winn
Original assignee: US Department of Veterans Affairs; University of California Berkeley; University of California San Diego UCSD
Current assignee: US Department of Veterans Affairs; University of California Berkeley; University of California San Diego UCSD
Priority date: 2023-10-25
Filing date: 2024-10-25
Publication date: 2025-05-01
Anticipated expiration: 2026-04-25

Abstract

Devices, methods, and kits are provided for measuring exophthalmos or enophthalmos. In particular, devices are provided for making either unilateral or bilateral measurements of exophthalmos or enophthalmos. The devices are designed for use during surgery with a patient in a supine position and are composed of a biocompatible metal, resin, or plastic that can withstand sterilization procedures. In addition, the devices can be produced inexpensively with a single-use design, which reduces the burden on sterile processing departments at hospitals, as a device may be discarded once a surgery is completed. The use of these devices will augment surgeons' qualitative visual estimations with quantitative measurements, which should make surgical procedures easier for surgeons to conduct and outcomes more precise and satisfactory for patients.

Description

INTRA-OPERATIVE EXOPHTHALMOMETER

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims benefit under 35 U.S.C. § 119(e) of provisional application 63/545,704, filed October 25, 2023, which application is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] Proptosis, also referred to as exophthalmos, is an abnormal protrusion of the eyeball from the eye socket. Thyroid eye disease is the leading cause of proptosis, but a wide variety of other ocular conditions, including vascular anomalies, benign and malignant neoplasms, and metabolic disease can also cause proptosis. In some cases, proptosis may be serious enough to result in loss of vision or even be life-threatening. Currently, orbital decompression is the main surgical intervention for treatment of proptosis due to thyroid eye disease and should be considered if proptosis is greater than 21 mm or the asymmetry between the protrusion of the right and left eyes of a patient is greater than 2 mm. In a reverse scenario, some patients may develop enophthalmos, or abnormal sinking of the eye into the eye socket. This may occur after fracture of the orbital bones, removal of a tumor, or atrophy of tissues. Surgical repair may consist of reconstructing bones or replacing lost volume with implants or other material.

[0003] While several devices currently exist to measure protrusion of the eye, the most commonly used Hertel Exophthalmometer cannot be sanitized appropriately for intraoperative use without damage to the expensive device. In addition, most of the devices are designed to be used with the patient upright rather than supine as they are during surgery. As such, intra-operative measurements of exophthalmos or enophthalmos are not currently part of standard-of-care. Currently, eye protrusion is usually only measured in the clinic before and after surgery. During surgery, surgeons decide the extent of the surgery based on visual assessment or palpation only, leading to over correction or under correction.

[0004] Thus, there remains a need for an exophthalmometer that can be sterilized and used conveniently during surgery with a patient in a supine position.

SUMMARY OF THE INVENTION

[0005] Devices, methods, and kits are provided for measuring exophthalmos or enophthalmos. In particular, devices are provided for making either unilateral or bilateral measurements of exophthalmos or enophthalmos. The devices are designed for use during surgery with a patient in a supine position and are composed of a biocompatible metal, resin or plastic that can withstand sterilization procedures. In addition, the devices can be produced inexpensively with a single-use design, which reduces the burden on sterile processing departments at hospitals, as a device may be discarded once a surgery is completed. The use of these devices will augment surgeons' qualitative visual estimations with quantitative measurements, which should make surgical procedures easier for surgeons to conduct and outcomes more precise and satisfactory for patients. [0006] In one aspect, a device for measuring exophthalmos or enophthalmos is provided, the device comprising: a base comprising a chamber; a chamber tip bulb attached to the bottom of the base, wherein the chamber tip bulb can be positioned on a lateral orbital rim of an eye of a patient; a slidable arm comprising a first end comprising a base attachment element and a second end comprising an eye rest element, wherein the base attachment element fits inside a complementary receiving location of the chamber to adjustably attach the slidable arm to the base such that the slidable arm projects orthogonally away from the base, wherein the base attachment element is moveable along the chamber vertically to allow the slidable arm to slide along the vertical length of the base until the eye rest element of the slidable arm rests on the eye of the patient to permit measurement of the exophthalmos or enophthalmos of the eye; and a measuring element on the base, wherein the measuring element can be used to measure distance between the lateral orbital rim and the eye rest element of the slidable arm when the eye rest element rests on the eye of the patient to determine the exophthalmos or enophthalmos of the eye.

[0007] In certain embodiments, the measuring element is an embossed ruler on an exterior surface of the base.

[0008] In certain embodiments, the measuring element is calibrated to zero at the lateral orbital rim.

[0009] In certain embodiments, the measuring element measures the distance in millimeters.

[0010] In certain embodiments, the chamber tip bulb is indented at the bottom at the end distal to the chamber.

[0011 ] In certain embodiments, the chamber tip bulb further comprises a downward projection at the end distal to the chamber, wherein the downward projection can hook the lateral orbital rim.

[0012] In certain embodiments, the device further comprises a built-in level to allow a user to keep the device horizontally aligned to accurately measure the exophthalmos or enophthalmos of the eye. In some embodiments, the level is a bubble level. In some embodiments, the level comprises a cylinder that is filled with a liquid (e.g., water) up to an engraved line. In some embodiments, the level is spherical. In some embodiments, the level is located on top of the slidable arm or the base. In some embodiments, the level is inside a cylindrical indent in an eye contact area on top of the slidable arm.

[0013] In certain embodiments, the slidable arm has a dovetail-square hybrid shape.

[0014] In certain embodiments, the base and the slidable arm further comprise chamfers.

[0015] In certain embodiments, the slidable arm can slide a distance of up to 30 mm along the vertical length of the base.

[0016] In certain embodiments, the slidable arm contacts an ocular surface and an eyelid when the eye rest element of the slidable arm rests on the eye of the patient.

[0017] In certain embodiments, the base further comprises an attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the attachment interface, wherein each chamber tip bulb of the plurality comprises different contact points. In some embodiments, the attachment interface comprises a slot for receiving one of the plurality of chamber tip bulbs, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot. This modular design allows one chamber tip bulb to be switched with another chamber tip bulb to change the contact points as desired by a user. In some embodiments, the contact points comprise Hertel-like or Naugle-like contact points. In some embodiments, the contact points are above and below the superior orbital rim, above and below the inferior orbital rim, on the lateral orbital rim, on the lateral orbital wall, or any combination thereof.

[0018] In certain embodiments, the chamber tip bulb further comprises inferior protrusions.

[0019] In certain embodiments, the base further comprises an attachment interface for attachment to a level that is removably attachable via the attachment interface. In some embodiments, the base comprises a cutout at the top of the chamber and a slot at the bottom in which modular pieces can be slid in. For example, a modular level can be slid into the cutout at the top of the chamber, and a chamber tip bulb with either Hertel-inspired or Naugle-inspired contact points may be slid into the slot at the bottom of the base.

[0020] In certain embodiments, the slidable arm has a width in a range from 8 mm to 20 mm, including any width within this range such as 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 1 1 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, 17.5 mm, 18 mm, 18.5 mm, 19 mm, 19.5 mm, or 20 mm.

[0021] In certain embodiments, the eye rest element can rest on an eyelid or cornea of the eye. In some embodiments, the eye rest element of the slidable arm is narrow enough to fit within an interpalpebral fissure and contact the cornea of the eye (e.g., to allow use even in cases where the eyelid is very swollen). In some embodiments, the eye rest element has a width of less than or equal to 8 mm.

[0022] In certain embodiments, the slidable arm further comprises a reinforcement spine.

[0023] In certain embodiments, the base further comprises a lever to control movement of the base attachment element of the slidable arm along the chamber vertically.

[0024] In certain embodiments, the slidable arm further comprises a locking mechanism such that the base attachment element is moveable along the chamber vertically and lockable at a selected position.

[0025] In certain embodiments, the base further comprises a horizontal push rod, wherein the horizontal push rod is located below the measuring element along an axis orthogonal to the measuring element. In some embodiments, the horizontal push rod comprises a locking mechanism, wherein pushing the horizontal push rod down locks the horizontal push rod in place. In some embodiments, the horizontal push rod contacts the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos.

[0026] In certain embodiments, the device comprises a bio-compatible and autoclavable resin or plastic.

[0027] In certain embodiments, the resin or plastic is compatible with three-dimensional (3 D)-printing of the device.

[0028] In certain embodiments, the resin or plastic comprises a methacrylic acid ester.

[0029] In certain embodiments, the resin or plastic is a photoreactive resin or plastic.

[0030] In certain embodiments, the device comprises a metal. In some embodiments, the metal is stainless steel, carbon steel, titanium, a titanium alloy, or aluminum.

[0031] In certain embodiments, the device is designed for multiple uses.

[0032] In certain embodiments, the device is designed for single-use.

[0033] In certain embodiments, the device is modular, wherein the chamber is designed for multiple uses, and the chamber tip bulb and the slidable arm are designed for single use. In some embodiments, the chamber comprises a metal, and the chamber tip bulb and the slidable arm comprise a plastic or a resin.

[0034] In certain embodiments, regions of the device that contact the patient's face have rounded edges.

[0035] In certain embodiments, the device further comprises a slot at the top of the chamber, said slot having a tapered thickness, wherein modular attachments can be inserted into the slot. In some embodiments, the device further comprises a modular level, wherein the modular level can be inserted into the slot.

[0036] In certain embodiments, the slidable arm further comprises a hole to allow a first reference dot to be marked on the face of the patient, and the chamber further comprises a hook to allow a second reference dot to be marked on the face of the patient. The hole in the arm has a diameter large enough to fit the tip of a marker through to allow a physician to place a reference dot on the face of the patient to help provide consistency of reference point selection for measurements. The chamber hook can also be used for marking the face of the patient prior to measurement. Prior to surgery, marking at both the hole in the arm and the chamber hook can provide 2 reference dots on the patient's skin. The exophthalmometer can be aligned to these dot's post-surgery to take a second set of measurements for comparison.

[0037] In another aspect, a method of using a device, described herein, for measuring exophthalmos or enophthalmos is provided, the method comprising: positioning a device for measuring exophthalmos or enophthalmos, described herein, on the face of a patient such that the eye rest element is over an eye; lowering the slidable arm until the eye rest element rests on the eye of the patient; and measuring exophthalmos or enophthalmos of the eye using the measuring element.

[0038] In certain embodiments, measuring exophthalmos or enophthalmos is performed during an ocular surgery such as, but not limited, to orbital fracture repair or orbital decompression. In some embodiments, exophthalmos or enophthalmos of the eye is measured multiple times during the ocular surgery using the device. In some embodiments, the method further comprises measuring exophthalmos or enophthalmos of the eye with the device before ocular surgery, after ocular surgery, or a combination thereof. In some embodiments, the method further comprises sterilizing the device prior to performing the ocular surgery.

[0039] In certain embodiments, the distance between the corneal apex and the lateral orbital rim is measured.

[0040] In certain embodiments, after measuring exophthalmos or enophthalmos of one eye, the method further comprises: positioning the device on the face of the patient such that the eye rest element is over the other eye of the patient; lowering the slidable arm until the eye rest element rests on the other eye of the patient; and measuring exophthalmos or enophthalmos of the other eye using the measuring element.

[0041] In certain embodiments, the method further comprises measuring the difference in the exophthalmos or enophthalmos of each eye.

[0042] In certain embodiments, the patient is in a supine position. [0043] In another aspect, a kit comprising a device for measuring exophthalmos or enophthalmos, described herein, and instructions for measuring exophthalmos or enophthalmos with the device is provided. In some embodiments, the device in the kit is sterilized and contained in a packaging comprising a sterile compartment for holding the device.

[0044] In another aspect, a bilateral device for measuring exophthalmos or enophthalmos is provided, the device comprising: a first base comprising a first chamber and a second base comprising a second chamber; a first chamber tip bulb attached to the bottom of the first base, wherein the first chamber tip bulb can be positioned on a first lateral orbital rim of a first eye of a patient and a second chamber tip bulb attached to the bottom of the second base, wherein the second chamber tip bulb can be positioned on a second lateral orbital rim of a second eye of the patient; a first slidable arm comprising a first end comprising a first base attachment element and a second end comprising a first eye rest element, wherein the first base attachment element fits inside a first complementary receiving location of the first chamber to adjustably attach the first slidable arm to the first base such that the first slidable arm projects orthogonally away from the first base, wherein the first base attachment element is moveable along the first chamber vertically to allow the first slidable arm to slide along the vertical length of the first base until the first eye rest element of the first slidable arm rests on the first eye of the patient to permit measurement of the exophthalmos or enophthalmos of the first eye; a second slidable arm comprising a first end comprising a second base attachment element and a second end comprising a second eye rest element, wherein the second base attachment element fits inside a second complementary receiving location of the second chamber to adjustably attach the second slidable arm to the second base such that the second slidable arm projects orthogonally away from the second base, wherein the second base attachment element is moveable along the second chamber vertically to allow the second slidable arm to slide along the vertical length of the second base until the second eye rest element of the second slidable arm rests on the second eye of the patient to permit measurement of the exophthalmos or enophthalmos of the second eye; a first measuring element on the first base, wherein the first measuring element can be used to measure distance between the first lateral orbital rim and the first eye rest element of the first slidable arm when the first eye rest element rests on the first eye of the patient to determine the exophthalmos or enophthalmos of the first eye; a second measuring element on the second base, wherein the second measuring element can be used to measure distance between the second lateral orbital rim and the second eye rest element of the second slidable arm when the second eye rest element rests on the second eye of the patient to determine the exophthalmos or enophthalmos of the second eye; and a bridge comprising a nose piece, wherein the bridge connects the first base to the second base, and wherein the nose piece contacts the nose bridge of the patient when the device is placed on the patient.

[0045] In certain embodiments, the first measuring element is a first embossed ruler on an exterior surface of the first base and the second measuring element is a second embossed ruler on an exterior surface of the second base.

[0046] In certain embodiments, the first measuring element is calibrated to zero at the first lateral orbital rim and the second measuring element is calibrated to zero at the second lateral orbital rim.

[0047] In certain embodiments, the first measuring element and the second measuring element measure the distance in millimeters.

[0048] In certain embodiments, the first chamber tip bulb is indented at the bottom of the end distal to the first chamber and the second chamber tip bulb is indented at the bottom of the end distal to the second chamber.

[0049] In certain embodiments, the first chamber tip bulb further comprises a first downward projection at the end distal to the first chamber, wherein the first downward projection can hook the first lateral orbital rim, and the second chamber tip bulb further comprises a second downward projection at the end distal to the second chamber, wherein the second downward projection can hook the second lateral orbital rim.

[0050] In certain embodiments, the bilateral device further comprises a built-in level to allow a user to keep the device horizontally aligned to accurately measure the exophthalmos or enophthalmos of the eye. In some embodiments, the level is a bubble level. In some embodiments, the level comprises a cylinder that is filled with a liquid (e.g., water) up to an engraved line. In some embodiments, the level is spherical. In some embodiments, the level is located on top of the first or second slidable arm, the first or second base, or the bridge. In some embodiments, the level is inside a cylindrical indent in an eye contact area on top of the first or second slidable arm.

[0051] In certain embodiments, the first slidable arm and the second slidable arm have a dovetailsquare hybrid shape.

[0052] In certain embodiments, the first and second bases and the first and second slidable arms further comprise chamfers.

[0053] In certain embodiments, the first slidable arm can slide a distance of up to 30 mm along the vertical length of the first base, and the second slidable arm can slide a distance of up to 30 mm along the vertical length of the second base.

[0054] In certain embodiments, the first slidable arm contacts a first ocular surface and eyelid when the first eye rest element of the first slidable arm rests on the first eye of the patient, and the second slidable arm contacts a second ocular surface and eyelid when the second eye rest element of the second slidable arm rests on the second eye of the patient.

[0055] In certain embodiments, the first and second chamber tip bulbs comprise modular contact points that can be switched. In certain embodiments, the modular contact points comprise Hertel- like or Naugle-like contact points.

[0056] In certain embodiments, the first base further comprises a first attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the first attachment interface, and the second base further comprises a second attachment interface for attachment to another one of the plurality of chamber tip bulbs that are removably attachable via the second attachment interface. In some embodiments, the first and second attachment interfaces each comprise a slot for receiving one of the plurality of chamber tip bulbs, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot to allow the plurality of chamber tip bulbs to be switched to change the contact points as desired by a user. The chamber tip bulbs attached to the first base and the second base may have the same contact points or different contact points.

[0057] In certain embodiments, the first base and/or the second base further comprise an attachment interface for attachment to a level that is removably attachable via the attachment interface. In some embodiments, the first base further comprises a cutout at the top of the first chamber, wherein a modular level can be slid into the cutout at the top of the first chamber. In some embodiments, the second base further comprises a cutout at the top of the second chamber, wherein a modular level can be slid into the cutout at the top of the second chamber.

[0058] In certain embodiments, the first eye rest element comprises contact points above and below the superior orbital rim of the first eye, above and below the inferior orbital rim of the first eye, on the lateral orbital rim of the first eye, on the lateral orbital wall or the first eye, or any combination thereof.

[0059] In certain embodiments, the second eye rest element comprises contact points above and below the superior orbital rim of the second eye, above and below the inferior orbital rim of the second eye, on the lateral orbital rim of the second eye, on the lateral orbital wall or the second eye, or any combination thereof.

[0060] In certain embodiments, the first and second slidable arms have a width in a range from 8 mm to 20 mm, including any width within this range such as 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 1 1 .5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, 17.5 mm, 18 mm, 18.5 mm, 19 mm, 19.5 mm, or 20 mm. [0061] In certain embodiments, the eye rest elements of the first and second slidable arms can rest on an eyelid or cornea of the eye. In some embodiments, the eye rest elements of the first and second slidable arms are narrow enough to fit within an interpalpebral fissure and contact the cornea of an eye (e.g., to allow use even in cases where the eyelid is very swollen). In some embodiments, the eye rest element has a width of less than or equal to 8 mm.

[0062] In certain embodiments, the first and second slidable arms each further comprise a reinforcement spine.

[0063] In certain embodiments, the first base further comprises a first lever to control movement of the first base attachment element of the first slidable arm along the first chamber vertically, and the second base further comprises a second lever to control movement of the second base attachment element of the second slidable arm along the second chamber vertically.

[0064] In certain embodiments, the first slidable arm further comprises a first locking mechanism such that the first base attachment element is moveable along the first chamber vertically and lockable at a first selected position, and the second slidable arm further comprises a second locking mechanism such that the second base attachment element is moveable along the second chamber vertically and lockable at a second selected position.

[0065] In certain embodiments, the first base further comprises a first horizontal push rod, wherein the first horizontal push rod is located below the first measuring element along an axis orthogonal to the first measuring element, and the second base further comprises a second horizontal push rod, wherein the second horizontal push rod is located below the second measuring element along an axis orthogonal to the second measuring element.

[0066] In certain embodiments, the first horizontal push rod comprises a first locking mechanism, wherein pushing the first horizontal push rod down locks the first horizontal push rod in place, and the second horizontal push rod comprises a second locking mechanism, wherein pushing the second horizontal push rod down locks the second horizontal push rod in place.

[0067] In certain embodiments, the first horizontal push rod and the second horizontal push rod contact the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos.

[0068] In certain embodiments, the bilateral device comprises a bio-compatible and autoclavable resin or plastic. In some embodiments, the resin or plastic is compatible with three-dimensional (3D)- printing of the device. In some embodiments, the resin or plastic comprises a methacrylic acid ester. In some embodiments, the resin or plastic is a photoreactive resin or plastic. [0069] In certain embodiments, the bilateral device comprises a metal. In some embodiments, the metal is stainless steel, carbon steel, titanium, a titanium alloy, or aluminum.

[0070] In certain embodiments, the bilateral device is designed for multiple uses.

[0071] In certain embodiments, the bilateral device is designed for single-use.

[0072] In certain embodiments, the bilateral device is modular, wherein the first chamber and the second chamber are designed for multiple uses, and the first and second chamber tip bulbs and the first and second slidable arms are designed for single use. In some embodiments, the first chamber and the second chamber comprise a metal and the first and second chamber tip bulbs and the first and second slidable arms comprise a plastic or a resin.

[0073] In certain embodiments, regions of the bilateral device that contact the patient's face have rounded edges.

[0074] In certain embodiments, the bilateral device further comprises a first slot at the top of the first chamber and a second slot at the top of the second chamber, each slot having a tapered thickness, wherein modular attachments can be inserted into the first slot and the second slot. In some embodiments, the bilateral device further comprises a modular level, wherein the modular level can be inserted into the first slot or the second slot.

[0075] In certain embodiments, the first and second slidable arms each further comprise a hole to allow a first reference dot to be marked on the face of the patient, and wherein the first and second chambers each further comprise a hook to allow a second reference dot to be marked on the face of the patient.

[0076] In another aspect, a method of using the bilateral device for measuring exophthalmos or enophthalmos is provided, the method comprising: positioning the device on the face of the patient such that the first eye rest element is over the first eye and the second eye rest element is over the second eye; lowering the first slidable arm until the first eye rest element rests on the first eye of the patient; lowering the second slidable arm until the second eye rest element rests on the second eye of the patient; measuring exophthalmos or enophthalmos of the first eye using the first measuring element; and measuring exophthalmos or enophthalmos of the second eye using the second measuring element.

[0077] In certain embodiments, exophthalmos or enophthalmos of the first eye and the second eye is measured during an ocular surgery such as, but not limited to, orbital fracture repair or orbital decompression. In some embodiments, the first eye and the second eye is measured multiple times during the ocular surgery using the device. In some embodiments, the method further comprises measuring exophthalmos or enophthalmos of the first eye and the second eye with the device before ocular surgery, after ocular surgery, or a combination thereof. In some embodiments, the method further comprises sterilizing the device prior to performing the ocular surgery.

[0078] In certain embodiments, measuring exophthalmos or enophthalmos of the first eye comprises measuring the distance between the corneal apex and the lateral orbital rim of the first eye, and measuring exophthalmos or enophthalmos of the second eye comprises measuring the distance between the corneal apex and the lateral orbital rim of the second eye.

[0079] In certain embodiments, the method further comprises measuring the difference in the exophthalmos or enophthalmos of the first eye and the second eye.

[0080] In certain embodiments, the patient is in a supine position.

[0081] In another aspect, a kit comprising a bilateral device for measuring exophthalmos or enophthalmos, described herein, and instructions for measuring exophthalmos or enophthalmos with the device is provided. In some embodiments, the device in the kit is sterilized and contained in a packaging comprising a sterile compartment for holding the device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0082] FIG. 1 shows an exemplary exophthalmometer for unilateral measurement of proptosis.

[0083] FIG. 2 shows an exemplary exophthalmometer for bilateral measurement of proptosis. The exophthalmometer has a bridge and contacts the nose bridge and both lateral orbital rims of a patient to convert the exophthalmometer into a bilateral measuring tool.

[0084] FIG. 3 shows version 1 .2 of the exophthalmometer, which comprises an arm, chamber, base, and brake, as illustrated.

[0085] FIG. 4 shows version 2.3 of the exophthalmometer. In this version, the base attachments of version 1 .2 were removed to create a smaller design having less material, which reduces the cost of production. Arm protrusions were added to make reading measurements easier.

[0086] FIG. 5 shows version 4.1 of the exophthalmometer, which has the following improvements over version 2.3: a dovetail cut for stability, a thicker arm, a chamber tip bulb (rests better on the lateral orbital rim), and lowered arm protrusions (change origin point).

[0087] FIG. 6 shows version 4.1 of the exophthalmometer. This version added an embossed ruler and a shrunken chamber for prototyping, which reduced material usage while adjusting tolerances. With this version, measurements were not calibrated to zero at the orbital rim of the patient.

[0088] FIG. 7 shows version 4.5 of the exophthalmometer. This version has an indented chamber tip bulb, which changes the origin point. This improvement allows measurements to be calibrated to zero at the orbital rim of the patient. [0089] FIG. 8 shows version 5.0 of the exophthalmometer. This version improves on version 4.5 by having a dovetail/square hybrid cut, which prevents jamming.

[0090] FIG. 9 shows version 5.5 of the exophthalmometer. This version improves on version 5.0 by having chamfers (eliminating 90° overhangs) for printing practicality.

[0091] FIG. 10 shows version 6.2 of the exophthalmometer. This version improves on version 5.5 by having additional chamfers and a reinforcement spine.

[0092] FIG. 11 shows version 6.4 of the exophthalmometer. This version improves on version 6.2 by re-extending the chamber to a 30 mm working range and using a taller arm block with less vertical wiggle.

[0093] FIG. 12 shows version 7.1 of the exophthalmometer. This version improves on version 6.4 by using a ruler in mm instead of cm, adding a built-in prototype level, having a reduced chamber tip bulb, which can hook to the orbital rim of a patient, and adding ergonomic cuts.

[0094] FIG. 13 shows version 7.3.3 of the exophthalmometer. This version improves on version 7.1 by using no hollow parts, which allows for easier curing and cleaning and having multi-part levels for printing practicality.

[0095] FIG. 14 shows an exemplary top view of the slidable arm illustrated in FIG. 10.

[0096] FIG. 15 shows an exemplary side view of the device illustrated in FIG. 10 with the slidable arm lowered to the bottom of the base.

[0097] FIG. 16 shows an exemplary side view of the device illustrated in FIG. 10 with the slidable arm raised.

[0098] FIG. 17 shows an exemplary side view of the device illustrated in FIG. 11 .

[0099] FIG. 18 shows an exemplary exophthalmometer comprising a small spherical level placed inside a cylindrical indent of the eye contact area. The level may be covered with a glass slide.

[00100] FIGS. 19A-19B show use of the exophthalmometer to take a measurement of proptosis of an eye of a patient, including a top view (FIG. 19A) and a side view (FIG. 19B) of the exophthalmometer.

[00101 ] FIG. 20 shows a physician placing the exophthalmometer on the face of a patient.

[00102] FIG. 21 shows a photograph of an exemplary exophthalmometer.

[00103] FIG. 22 shows an exophthalmometer having a reduced arm piece. The width of the arm piece has been reduced from 20 mm to 8 mm, which allows for contact with the ocular surface as well as the eyelid.

[00104] FIG. 23 shows an exophthalmometer having a thumb lever, which provides easier manipulation of the arm while holding the chamber stabile. [00105] FIG. 24 shows an exophthalmometer having modular contact points, which can be switched between Hertel inspired and Naugle inspired contact points.

[00106] FIG. 25 shows an exophthalmometer comprising a cylinder, which can be filled with a liquid (e.g., water) up to an engraved line to serve as a spirit level.

[00107] FIG. 26 shows an exophthalmometer having a horizontal push rod, which can be moved along an axis orthogonal to a ruler. The horizontal push rod can be pushed down to lock it in place. The horizontal push rod also provides an additional point of contact with a patient’s face.

[00108] FIG. 27 shows a modular chamber tip bulb having "Naugle-like" reference contact points and inferior protrusions.

[00109] FIGS. 28A-28D show an exophthalmometer having a cutout at the top of the chamber and a slot at the bottom in which modular pieces can be slid in. Modular pieces include a level and a chamber tip bulb with either Hertel-inspired or Naugle-inspired contact points. FIG. 28A shows the base with the modular level and chamber tip bulb with Naugle-inspired contact points positioned to be slid into the base. FIG. 28B shows the base with the modular level and chamber tip bulb with Hertel-inspired contact points positioned to be slid into the base. FIG. 28C shows the base with the modular level and chamber tip bulb with Naugle-inspired contact points slid into the base. FIG. 28D shows the base with the modular level and chamber tip bulb with Hertel-inspired contact points slid into the base.

[00110] FIG. 29 shows an exophthalmometer having the pieces that contact a patient's face during normal use designed with rounded edges to improve comfort.

[00111] FIG. 30 shows an exophthalmometer having a slot with tapered thickness at the top part of the chamber that allows for extra modular attachments to be added. A level finder can be designed to fit in the slot, as depicted.

[00112] FIGS. 31A-31 B shows an exophthalmometer having hollowed out holes in the device at contact points on the face of a patient. The holes are designed to have a diameter large enough to fit the tip of a marker through to allow a physician to place reference dots on the face of the patient to help provide consistency of reference point selection for measurements. FIG. 31 A shows an arm with a hole, which allows a surgeon to dot the point of measurement using a marking pen to provide for consistency of measurements. FIG. 31 B shows a chamber with a hook, which can also be used for marking the face of the patient prior to measurement. When marking the points of measurement, the hook can be colored on with a marker before use. When the hook contacts the patient's face, the residual ink on the hook leaves a dot on the patient's skin. Next, the sliding arm potion of the device is brought down to the level of the patient's eyelid to take the initial measurement. The surgeon can make a second dot through the hole in the arm of the device. After the surgery is completed, the tool can be aligned to these 2 dots once again to take a second set of measurements.

DETAILED DESCRIPTION OF THE INVENTION

[00113] Devices, methods, and kits are provided for measuring exophthalmos or enophthalmos. In particular, devices are provided for making either unilateral or bilateral measurements of exophthalmos or enophthalmos. The devices are designed for use during surgery with a patient in a supine position and are composed of a biocompatible metal, resin, or plastic that can withstand sterilization procedures. In addition, the devices can be produced inexpensively with a single-use design, which reduces the burden on sterile processing departments at hospitals, as a device may be discarded once a surgery is completed. The use of these devices will augment surgeons' qualitative visual estimations with quantitative measurements, which should make surgical procedures easier for surgeons to conduct and outcomes more precise and satisfactory for patients.

[00114] Before the present devices, methods, and kits are described, it is to be understood that this invention is not limited to the particular devices, systems, software, and methods described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[00115] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[00116] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.

[00117] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

[00118] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "an eye" includes a plurality of such eyes and reference to "the device" includes reference to one or more devices and equivalents thereof, known to those skilled in the art, and so forth.

[00119] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

Definitions

[00120] The term "about," particularly in reference to a given quantity, is meant to encompass deviations of plus or minus five percent.

[00121] The terms “individual”, “subject”, “recipient”, and “patient” are used interchangeably herein and refer to any mammalian subject for whom diagnosis, treatment, or therapy is desired, particularly humans. "Mammal" for purposes of treatment refers to any animal classified as a mammal, including human and non-human mammals such as non-human primates, including chimpanzees and other apes and monkey species; laboratory animals such as mice, rats, rabbits, hamsters, guinea pigs, and chinchillas; domestic animals such as dogs and cats; and farm animals such as sheep, goats, pigs, horses and cows.

[00122] The term “user” as used herein refers to a person that uses a device disclosed herein for performing one or more steps of the presently disclosed methods for measuring exophthalmos or enophthalmos. The user may be a health care practitioner, such as the patient’s physician or a surgeon performing ocular surgery on the patient such as orbital decompression or orbital fracture repair. [00123] The terms “proptosis” and “exophthalmos” are used interchangeably and refer to anterior displacement of the eyeball from the orbit.

[00124] The term “enophthalmos” refers to posterior displacement of the eyeball from the orbit.

Devices and Methods for Measuring Exophthalmos or Enophthalmos

[00125] Devices are provided for measuring exophthalmos or enophthalmos. The devices are designed for use during surgery with a patient in a supine position (though can also be used outside of a surgical setting) and are composed of a biocompatible metal, resin, or plastic that can withstand sterilization procedures. In addition, the devices can be produced inexpensively with a single-use design, which reduces the burden on sterile processing departments at hospitals, as a device may be discarded once a surgery is completed. The use of these devices will augment surgeons' qualitative visual estimations with quantitative measurements, which should make surgical procedures easier for surgeons to conduct and outcomes more precise and satisfactory for patients.

[00126] In certain embodiments, devices designed for making unilateral measurements of exophthalmos or enophthalmos are provided. For example, see FIGS. 1 , 3-17, and 21 -26, which depict exemplary devices designed to make unilateral measurements of a single eye at a time. In an exemplary embodiment, illustrated in FIG. 1 , the device 100 comprises: a base 110 comprising a chamber 111 ; a chamber tip bulb 112 attached to the bottom of the base 110, wherein the chamber tip bulb 1 12 can be positioned on a lateral orbital rim of an eye of a patient; a slidable arm 120 comprising a first end comprising a base attachment element 121 , a second end comprising an eye rest element 122, and a spine 123, wherein the base attachment element 121 fits inside a complementary receiving location of the chamber 11 1 to adjustably attach the slidable arm 120 to the base 1 10 such that the slidable arm 120 projects orthogonally away from the base 1 10, wherein the base attachment element 121 is moveable along the chamber 111 vertically to allow the slidable arm 120 to slide along the vertical length of the base 1 10 until the eye rest element 122 of the slidable arm rests on the eye of the patient to permit measurement of the exophthalmos or enophthalmos of the eye; and a measuring element 130 on the base 110, wherein the measuring element 130 can be used to measure distance between the lateral orbital rim and the eye rest element 122 of the slidable arm when the eye rest element rests on the eye of the patient to determine the exophthalmos or enophthalmos of the eye.

[00127] In certain embodiments, the device further comprises a built-in level 140 to allow a user to keep the device horizontally aligned to accurately measure exophthalmos or enophthalmos of an eye. In some embodiments, the level is a bubble level. As illustrated in FIG. 18, a small spherical level may be placed inside a cylindrical indent in an eye contact area on top of the slidable arm. As illustrated in FIG. 25, the exophthalmometer may comprise a cylinder, which can be filled with a liquid (e.g., water) up to an engraved line to serve as a spirit level. In some exemplary embodiments, the level is located on top of the slidable arm, as shown in FIG. 1 and FIG. 18, or above the base, as shown in FIG. 25.

[00128] For such devices designed to make unilateral measurements, exophthalmos or enophthalmos is measured by a method comprising: positioning the device on the face of a patient such that the eye rest element is over an eye; lowering the slidable arm until the eye rest element rests on the eye of the patient; and measuring exophthalmos or enophthalmos of the eye using the measuring element. Measurements of exophthalmos or enophthalmos of the other eye require moving the device to position the eye rest element over the other eye, lowering the slidable arm until the eye rest element rests on the other eye of the patient; and measuring exophthalmos or enophthalmos of the other eye using the measuring element.

[00129] The terms “proptosis” and “exophthalmos” refer to anterior displacement of the eyeball from the orbit, whereas the term “enophthalmos” refers to the posterior displacement of the eyeball from the orbit. The position of the eyeball along the anterior-posterior axis of the eyeball can be measured as the distance (or orbital distance) between the lateral orbital rim and the corneal apex (the front surface of the eyeball). In some cases, the measurement of exophthalmos or enophthalmos is compared with a reference value range (e.g., normal eye of a healthy subject not having abnormal bulging of the eyeball out of the orbit or abnormal downward displacement or sinking of the eyeball into the eye socket, or a disorder that causes exophthalmos or enophthalmos). The measurement of exophthalmos or enophthalmos may be compared to measurements previously taken of the same eye of the patient. In some embodiments, measurements of exophthalmos or enophthalmos are taken of both eyes of the patient and measurements of the right eye and the left eye are compared with each other, for example, to match the protrusion of the eyeballs for the right eye and the left eye during surgery.

[00130] As shown in the exemplary embodiment illustrated in FIG. 5, the measuring element 130 on the base 110 of the device may be an embossed ruler on the exterior surface of the base. Alternatively, the measuring element can be a ruler, manufactured separately from the device, wherein the ruler is attached to the device, for example, with an adhesive, nails, or screws, or other attachment means. In certain embodiments, the measuring element is calibrated to zero at the lateral orbital rim. The measuring element may have any suitable scale such as cm, mm, or inches. In certain embodiments, the measuring element measures exophthalmos or enophthalmos in millimeters.

[00131] As shown in FIG. 7, the chamber tip bulb may be indented at the bottom at the end distal to the chamber. As further illustrated in FIG. 12, the chamber tip bulb may further comprise a downward projection at the end distal to the chamber, wherein the downward projection can hook the lateral orbital rim to assist placement of the device on the patient for measuring exophthalmos or enophthalmos.

[00132] In some embodiments, the device has a modular design. As shown in FIG. 24, the chamber tip bulb may comprise modular contact points that can be switched. For example, the modular contact points may comprise Hertel-like or Naugle-like contact points. In certain embodiments, the contact points are above and below the superior orbital rim, above and below the inferior orbital rim, on the lateral orbital rim, on the lateral orbital wall, or any combination thereof. As shown in FIG. 27, the chamber tip bulb may further comprise inferior protrusions.

[00133] In certain embodiments, the base in the modular device comprises an attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the attachment interface, wherein each chamber tip bulb of the plurality comprises different contact points. In an exemplary embodiment of a modular device, shown in FIGS. 28A-28D, the attachment interface comprises a slot for receiving one of the chamber tip bulbs of the plurality, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot. This modular design allows one chamber tip bulb to be switched with another chamber tip bulb to change the contact points as desired by a user.

[00134] In certain embodiments, the base further comprises an attachment interface for attachment to a modular level that is removably attachable via the attachment interface. FIGS. 28A-28D show an exemplary modular exophthalmometer having a cutout at the top of the chamber and a slot at the bottom in which modular pieces can be slid in. For example, a modular level can be slid into the cutout at the top of the chamber, and a chamber tip bulb with either Hertel-inspired or Naugle-inspired contact points may be slid into the slot at the bottom of the base. In some embodiments, the exophthalmometer comprises a tapered thickness slot at the top part of the chamber that allows for modular attachments to be added (FIG. 30).

[00135] An advantage of the device having a modular build is that the largest piece, the chamber, can be made out of a reusable material (e.g., metal), whereas the pieces that contact the patient's face such as the chamber tip bulb and the slidable arm can be single use, disposable products (e.g., composed of plastic or a resin), and can be selected on a case-to-case basis. The modular design makes production, distribution, and sanitation easier.

[00136] Patients may have their eyes open or closed during measurements of exophthalmos or enophthalmos. The slidable arm is lowered until it contacts an ocular surface and/or eyelid of the eye of the patient (see, e.g., FIGS. 19A and 19B). In certain embodiments, the slidable arm can slide a distance of up to 30 mm along the vertical length of the base. As shown in FIG. 23, the base may further comprise a lever to control movement of the base attachment element of the slidable arm along the chamber vertically. In certain embodiments, the slidable arm further comprises a locking mechanism such that the base attachment element is moveable along the chamber vertically and lockable at a selected position. The parts of the device that contact a patient's face can be designed with rounded edges to improve comfort for a patient, as shown in FIG. 29.

[00137] In certain embodiments, the slidable arm has a width in a range from 8 mm to 20 mm, including any width within this range such as 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 1 1 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, 17.5 mm, 18 mm, 18.5 mm, 19 mm, 19.5 mm, or 20 mm. As illustrated in FIG. 8, the slidable arm may have a dovetail-square hybrid shape. In certain embodiments, the eye rest element can rest on an eyelid or cornea of the eye. In some embodiments, the eye rest element of the slidable arm is narrow enough to fit within an interpalpebral fissure and contact the cornea of the eye (e.g., to allow use even in cases where the eyelid is very swollen). In some embodiments, the eye rest element has a width of less than or equal to 8 mm.

[00138] The base and the slidable arm may further comprise chamfers, as illustrated in FIGS. 9 and 10. In an exemplary embodiment illustrated in FIG. 10, the slidable arm further comprises a reinforcement spine.

[00139] In an exemplary embodiment illustrated in FIG. 26, the base further comprises a horizontal push rod, wherein the horizontal push rod is located below the measuring element along an axis orthogonal to the measuring element. The horizontal push rod contacts the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos. In certain embodiments, the horizontal push rod comprises a locking mechanism, wherein pushing the horizontal push rod down locks the horizontal push rod in place.

[00140] Holes can be added to an exophthalmometer at contact points to allow marking of reference points on the face of a patient. The holes are designed to have a diameter large enough to fit the tip of a marker through to allow a physician to place reference dots on the face of the patient to help provide consistency of reference point selection for measurements. FIG. 31 A shows an arm with a hole, which allows a surgeon to dot the point of measurement using a marking pen to provide for consistency of measurements. FIG. 31 B shows a chamber with a hook, which can also be used for marking the face of the patient prior to measurement. When marking the points of measurement, the hook can be colored on with a marker before use. When the hook contacts the patient's face, the residual ink on the hook leaves a dot on the patient's skin. Next, the sliding arm potion of the device is brought down to the level of the patient's eyelid to take the initial measurement. The surgeon can make a second dot through the hole in the arm of the device. After the surgery is completed, the tool can be aligned to these 2 dots once again to take a second set of measurements..

[00141] In some embodiments, devices designed for making bilateral measurements of exophthalmos or enophthalmos are provided. In an exemplary embodiment, illustrated in FIG. 2, the device 200 comprises: a first base 210 comprising a first chamber 211 and a second base 260 comprising a second chamber 261 ; a first chamber tip bulb 212 attached to the bottom of the first base 210, wherein the first chamber tip bulb 212 can be positioned on a first lateral orbital rim of a first eye of a patient and a second chamber tip bulb 262 attached to the bottom of the second base 260, wherein the second chamber tip bulb 262 can be positioned on a second lateral orbital rim of a second eye of the patient; a first slidable arm 220 comprising a first end comprising a first base attachment element and a second end comprising a first eye rest element 222, wherein the first base attachment element fits inside a first complementary receiving location of the first chamber 211 to adjustably attach the first slidable arm 220 to the first base such that the first slidable arm 220 projects orthogonally away from the first base 210, wherein the first base attachment element is moveable along the first chamber 211 vertically to allow the first slidable arm 220 to slide along the vertical length of the first base 210 until the first eye rest element of the first slidable arm 220 rests on the first eye of the patient to permit measurement of the exophthalmos or enophthalmos of the first eye; a second slidable arm 270 comprising a first end comprising a second base attachment element and a second end comprising a second eye rest element 272, wherein the second base attachment element fits inside a second complementary receiving location of the second chamber 261 to adjustably attach the second slidable arm 270 to the second base 260 such that the second slidable arm 270 projects orthogonally away from the second base 260, wherein the second base attachment element is moveable along the second chamber 261 vertically to allow the second slidable arm 270 to slide along the vertical length of the second base 260 until the second eye rest element of the second slidable arm 270 rests on the second eye of the patient to permit measurement of the exophthalmos or enophthalmos of the second eye; a first measuring element on the first base 230, wherein the first measuring element 230 can be used to measure distance between the first lateral orbital rim and the first eye rest element of the first slidable arm 220 when the first eye rest element 222 rests on the first eye of the patient to determine the exophthalmos or enophthalmos of the first eye; a second measuring element 280 on the second base 260, wherein the second measuring element 280 can be used to measure distance between the second lateral orbital rim and the second eye rest element 272 of the second slidable arm when the second eye rest element 272 rests on the second eye of the patient to determine the exophthalmos or enophthalmos of the second eye; and a bridge 250 comprising a nose piece 251 , wherein the bridge 250 connects the first base 210 to the second base 260, and wherein the nose piece 251 contacts the nose bridge of the patient when the device 200 is placed on the patient for measuring exophthalmos or enophthalmos.

[00142] For this embodiment of the device 200, exophthalmos or enophthalmos may be measured by a method comprising: positioning the device on the face of the patient such that the first eye rest element is over the first eye and the second eye rest element is over the second eye; lowering the first slidable arm until the first eye rest element rests on the first eye of the patient; lowering the second slidable arm until the second eye rest element rests on the second eye of the patient; measuring exophthalmos or enophthalmos of the first eye using the first measuring element; and measuring exophthalmos or enophthalmos of the second eye using the second measuring element. This embodiment of the device 200 has the advantage that exophthalmos or enophthalmos of the first eye (i.e., distance between the corneal apex and the lateral orbital rim of the first eye) and exophthalmos or enophthalmos of the second eye (i.e., distance between the corneal apex and the lateral orbital rim of the second eye) can both be measured without repositioning the device.

[00143] In certain embodiments, the first measuring element is a first embossed ruler on an exterior surface of the first base and the second measuring element is a second embossed ruler on an exterior surface of the second base. In certain embodiments, the first measuring element is calibrated to zero at the first lateral orbital rim and the second measuring element is calibrated to zero at the second lateral orbital rim. In certain embodiments, the first measuring element and the second measuring element measure the distance in millimeters.

[00144] In certain embodiments, the first chamber tip bulb is indented at the bottom of the end distal to the first chamber and the second chamber tip bulb is indented at the bottom of the end distal to the second chamber. In certain embodiments, the first chamber tip bulb further comprises a first downward projection at the end distal to the first chamber, wherein the first downward projection can hook the first lateral orbital rim, and the second chamber tip bulb further comprises a second downward projection at the end distal to the second chamber, wherein the second downward projection can hook the second lateral orbital rim. [00145] In certain embodiments, the device further comprises a built-in level to allow a user to keep the device horizontally aligned to accurately measure the exophthalmos or enophthalmos of the eye. In some embodiments, the level is a bubble level. In some embodiments, the level comprises a cylinder that is filled with a liquid (e.g., water) up to an engraved line. In some embodiments, the level is spherical. In some embodiments, the level is located on top of the first or second slidable arm, the first or second base, or the bridge. In some embodiments, the level is inside a cylindrical indent in an eye contact area on top of the first or second slidable arm.

[00146] In certain embodiments, the first slidable arm and the second slidable arm have a dovetailsquare hybrid shape. In certain embodiments, the first and second bases and the first and second slidable arms further comprise chamfers. In certain embodiments, the first slidable arm can slide a distance of up to 30 mm along the vertical length of the first base, and the second slidable arm can slide a distance of up to 30 mm along the vertical length of the second base.

[00147] In certain embodiments, the first slidable arm contacts a first ocular surface and eyelid when the first eye rest element of the first slidable arm rests on the first eye of the patient, and the second slidable arm contacts a second ocular surface and eyelid when the second eye rest element of the second slidable arm rests on the second eye of the patient.

[00148] In certain embodiments, the bilateral device is modular, wherein the first and second chamber tip bulbs comprise modular contact points that can be switched. In certain embodiments, the modular contact points comprise Hertel-like or Naugle-like contact points. In certain embodiments, the first chamber tip bulb comprises contact points are above and below the superior orbital rim of the first eye, above and below the inferior orbital rim of the first eye, on the lateral orbital rim of the first eye, on the lateral orbital wall or the first eye, or any combination thereof. In certain embodiments, the second chamber tip bulb comprises contact points above and below the superior orbital rim of the second eye, above and below the inferior orbital rim of the second eye, on the lateral orbital rim of the second eye, on the lateral orbital wall or the second eye, or any combination thereof. In certain embodiments, the first and second chamber tip bulbs further comprise inferior protrusions, as shown in FIG. 27.

[00149] In certain embodiments, the bilateral device is modular, wherein the first base further comprises a first attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the first attachment interface, and the second base further comprises a second attachment interface for attachment to another one of the plurality of chamber tip bulbs that are removably attachable via the second attachment interface. In some embodiments, the first and second attachment interfaces each comprise a slot for receiving one of the plurality of chamber tip bulbs, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot to allow the plurality of chamber tip bulbs to be switched to change the contact points if desired by a user. The chamber tip bulbs attached to the first base and the second base may have the same contact points or different contact points.

[00150] In certain embodiments, the first base and/or the second base further comprise an attachment interface for attachment to a level that is removably attachable via the attachment interface. As shown in an exemplary embodiment, illustrated in FIGS. 28A-28D, each base in the bilateral device may have a cutout at the top of the chamber and a slot at the bottom in which modular pieces can be slid in. For example, a modular level can be slid into cutouts at the top of the first chamber and/or the second chamber, and a chamber tip bulb with either Hertel-inspired or Naugle- inspired contact points may be slid into the slots at the bottom of the first base and/or the second base.

[00151] In certain embodiments, the first and second slidable arms have a width in a range from 8 mm to 20 mm, including any width within this range such as 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 1 1 .5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, 17.5 mm, 18 mm, 18.5 mm, 19 mm, 19.5 mm, or 20 mm. In certain embodiments, the eye rest elements of the first and second slidable arms can rest on an eyelid or cornea of the eye. In some embodiments, the eye rest elements of the first and second slidable arms are narrow enough to fit within an interpalpebral fissure and contact the cornea of an eye (e.g., to allow use even in cases where the eyelid is very swollen). In some embodiments, the eye rest element has a width of less than or equal to 8 mm. In certain embodiments, the first and second slidable arms each further comprise a reinforcement spine.

[00152] In certain embodiments, the first base further comprises a first lever to control movement of the first base attachment element of the first slidable arm along the first chamber vertically, and the second base further comprises a second lever to control movement of the second base attachment element of the second slidable arm along the second chamber vertically.

[00153] In certain embodiments, the first slidable arm further comprises a first locking mechanism such that the first base attachment element is moveable along the first chamber vertically and lockable at a first selected position, and the second slidable arm further comprises a second locking mechanism such that the second base attachment element is moveable along the second chamber vertically and lockable at a second selected position.

[00154] In certain embodiments, the first base further comprises a first horizontal push rod, wherein the first horizontal push rod is located below the first measuring element along an axis orthogonal to the first measuring element, and the second base further comprises a second horizontal push rod, wherein the second horizontal push rod is located below the second measuring element along an axis orthogonal to the second measuring element. In certain embodiments, the first horizontal push rod comprises a first locking mechanism, wherein pushing the first horizontal push rod down locks the first horizontal push rod in place, and the second horizontal push rod comprises a second locking mechanism, wherein pushing the second horizontal push rod down locks the second horizontal push rod in place. In certain embodiments, the first horizontal push rod and the second horizontal push rod contact the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos.

[00155] In certain embodiments, exophthalmos or enophthalmos is measured, using a device disclosed herein, to monitor a patient having a condition that causes exophthalmos or enophthalmos, or a condition in which the treatment of the condition may cause exophthalmos or enophthalmos. Such conditions include, but are not limited to, thyroid eye disease (thyroid associated orbitopathy, Graves' ophthalmopathy, Hashimoto’s thyroiditis), orbital cellulitis, dacryoadenitis, Erdheim-Chester disease, mucormycosis, an orbital pseudotumor, high-altitude cerebral edema, granulomatosis with polyangiitis, nasopharyngeal angiofibroma, Hand-Schuller-Christian disease, hemangioma, dermoid cysts, aortic insufficiency, orbital fracture (e.g., apex, floor, medial wall, zygomatic), retrobulbar hemorrhage, carotid-cavernous fistulas, Cushing’s syndrome, craniosynostosis (e.g., Crouzon syndrome, Pfeiffer syndrome, pansynostosis), orbital varix, orbital lymphatic malformations, capillary hemangioma, cavernous hemangioma, pseudoenophthalmos, facial asymmetry, contralateral proptosis, microphthalmos, ptosis, developmental anomalies such as cranialstenosis, inflammatory conditions such as granulomatosis with polyangiitis (Wegener’s granulomatosis), idiopathic orbital inflammation, tuberculosis, orbital myositis, and atypical mycobacterial infection, vascular anomalies, effects of pressure, iatrogenic injuries, or radiotherapy, cavernous sinus thrombosis, orbital neoplasms, orbital metastasis, metastatic neuroblastoma, scirrhous breast carcinoma, gastric carcinoma, lung carcinoma, rhabdomyosarcoma, epithelial cyst, glioma of the optic nerve, meningioma, hemangioma, orbital extension of retinoblastoma, orbital lymphoma and leukemias, mucocele, lacrimal gland tumor, structural abnormalities, paranasal sinus mucoceles, maxillary sinus disease, chronic maxillary sinusitis, silent sinus syndrome, maxillary hypoplasia, bony defects such as caused by the absence of the greater sphenoid wing, neurofibromatosis, orbital bony defects, congenital defects such as congenital bony orbital asymmetry or congenital fibrosis of the extraocular muscles (CFEOM), bone diseases such as Paget’s disease, fat atrophy, senile enophthalmos, periorbital/systemic diseases such as lipodystrophy, scleroderma, and Parry-Romberg syndrome, blue rubber bleb naevus syndrome, schizophrenia, Leber’s congenital amaurosis, Cockayne’s dystropyhy, hydrocephalus and V-P shunt, restrictive myopathy, Duane’s retraction syndrome, sarcoidosis, primary orbital leiomyoma, posterior traction secondary to fibrosis of the extraocular muscles or connective tissues, chromosomal disorders such as trisomy 9p and trisomy 7q, and Horner’s syndrome, or any other condition that causes orbital trauma or structural abnormalities resulting in exophthalmos or enophthalmos. For a review of conditions that cause exophthalmos or enophthalmos, see, e.g., Topilow et al. (2020) Intern. Med. Rev. (Wash D C) 6(3) : 10 and Athanasiov et al. (2008) Acta Ophthalmol. 86(4):356-364.

[00156] In certain embodiments, exophthalmos or enophthalmos is measured during an ocular surgery such as, but not limited, to orbital fracture repair or orbital decompression. Either a device for making unilateral measurements of exophthalmos or enophthalmos or a device for making bilateral measurements of exophthalmos or enophthalmos, as described herein, may be used. The device will generally be sterilized prior to performing the ocular surgery. Exophthalmos or enophthalmos of one or both eyes may be measured a single time or multiple times during the ocular surgery using the device while the patient is in a supine position. The eye lids of the patient may be open or closed during measurements. Exophthalmos or enophthalmos of one or both eyes may also be measured with the device before and/or after ocular surgery.

[00157] In certain embodiments, the device for measuring exophthalmos or enophthalmos is composed of a bio-compatible and autoclavable resin or plastic to allow sterilization of the device prior to performing ocular surgery. In some embodiments, the resin or plastic is compatible with three-dimensional (3D)-printing of the device. For example, resins comprising a photoreactive methacrylic acid ester such as BioMed Clear from Formlabs (Somerville, MA) or other suitable resins can be used in 3D-printing of the device. Various 3D printing systems may be used in manufacturing the devices, including digital light processing (DLP), liquid crystal display (LCD), and stereolithography (SLA), selective laser sintering (SLS), and other laser-based 3D printing systems, among others. The devices can be produced inexpensively and designed for single-use (see Examples) to reduce the burden on sterile processing departments of hospitals, as a device may be discarded once a surgery is completed. Alternatively, the device may be designed for multiple uses. In some embodiments, the device is composed of a metal such as, but not limited to stainless steel, carbon steel, titanium, a titanium alloy, or aluminum. For modular devices, the chamber, can be made out of a reusable material (e.g., metal), whereas the pieces that contact the patient's face such as the chamber tip bulb and the slidable arm can be single use, disposable products (e.g., composed of plastic or a resin). Kits

[00158] Any of the devices for measuring exophthalmos or enophthalmos, described herein, may be provided in a kit. In some embodiments, the kit comprises a device for making unilateral measurements of exophthalmos or enophthalmos. In other embodiments, the kit comprises a device for making bilateral measurements of exophthalmos or enophthalmos. The kit may also include a packaging that includes a compartment, e.g., a sterile compartment, for holding the device. The packaging may be any suitable packaging for holding the device. Examples of packaging and methods of packaging are described in, e.g., U.S. Pat. Nos. 3,755,042, 4,482,053, 4,750,619; U.S. App. Pub. Nos. 20050268573, 20100133133, each of which are incorporated herein by reference.

[00159] In addition to the above components, the subject kits may further include (in certain embodiments) instructions for using the device to measure exophthalmos or enophthalmos. These instructions may be present in the subject kits in a variety of forms, one or more of which may be present in the kit. One form in which these instructions may be present is as printed information on a suitable medium or substrate, e.g., a piece or pieces of paper on which the information is printed, in the packaging of the kit, in a package insert, and the like. Yet another form of these instructions is a computer readable medium, e.g., diskette, compact disk (CD), flash drive, and the like, on which the information has been recorded. Yet another form of these instructions that may be present is a website address which may be used via the internet to access the information at a removed site.

Utility

[00160] The devices described herein are useful for measuring exophthalmos (i.e., abnormal protrusion of the eyeball from the eye socket) or enophthalmos (i.e., abnormal sinking of the eyeball into the eye socket). The devices can be used for measuring exophthalmos or enophthalmos for any condition that causes exophthalmos or enophthalmos, or for conditions in which the treatment of the condition causes exophthalmos or enophthalmos, including, but not limited to, thyroid eye disease (thyroid associated orbitopathy, Graves' ophthalmopathy, Hashimoto’s thyroiditis), orbital cellulitis, dacryoadenitis, Erdheim-Chester disease, mucormycosis, an orbital pseudotumor, high-altitude cerebral edema, granulomatosis with polyangiitis, nasopharyngeal angiofibroma, Hand-Schuller- Christian disease, hemangioma, dermoid cysts, aortic insufficiency, orbital fracture (e.g., apex, floor, medial wall, zygomatic), retrobulbar hemorrhage, carotid-cavernous fistulas, Cushing’s syndrome, and craniosynostosis (e.g., Crouzon syndrome, Pfeiffer syndrome, pansynostosis), orbital varix, orbital lymphatic malformations, capillary hemangioma, cavernous hemangioma, pseudoenophthalmos, facial asymmetry, contralateral proptosis, microphthalmos, ptosis, developmental anomalies such as cranialstenosis, inflammatory conditions such as granulomatosis with polyangiitis (Wegener’s granulomatosis), idiopathic orbital inflammation, tuberculosis, orbital myositis, and atypical mycobacterial infection, vascular anomalies, effects of pressure, iatrogenic injuries, or radiotherapy, cavernous sinus thrombosis, orbital neoplasms, orbital metastasis, metastatic neuroblastoma, scirrhous breast carcinoma, gastric carcinoma, lung carcinoma, rhabdomyosarcoma, epithelial cyst, glioma of the optic nerve, meningioma, hemangioma, orbital extension of retinoblastoma, orbital lymphoma and leukemias, mucocele, lacrimal gland tumor, structural abnormalities, paranasal sinus mucoceles, maxillary sinus disease, chronic maxillary sinusitis, silent sinus syndrome, maxillary hypoplasia, bony defects such as caused by the absence of the greater sphenoid wing, neurofibromatosis, orbital bony defects, congenital defects such as congenital bony orbital asymmetry or congenital fibrosis of the extraocular muscles (CFEOM), bone diseases such as Paget’s disease, fat atrophy, senile enophthalmos, periorbital/systemic diseases such as lipodystrophy, scleroderma, and Parry-Romberg syndrome, blue rubber bleb naevus syndrome, schizophrenia, Leber’s congenital amaurosis, Cockayne’s dystropyhy, hydrocephalus and V-P shunt, restrictive myopathy, Duane’s retraction syndrome, sarcoidosis, primary orbital leiomyoma, posterior traction secondary to fibrosis of the extraocular muscles or connective tissues, chromosomal disorders such as trisomy 9p and trisomy 7q, and Horner’s syndrome, or any other condition that causes orbital trauma or structural abnormalities resulting in exophthalmos or enophthalmos. For a review of conditions that cause exophthalmos or enophthalmos, see, e.g., Topilow et al. (2020) Intern. Med. Rev. (Wash D C) 6(3):10 and Athanasiov et al. (2008) Acta Ophthalmol. 86(4):356-364.

[00161] In particular, the devices can be used for making measurements of exophthalmos or enophthalmos during ocular surgeries. Although several devices currently exist to measure protrusion of the eye, other devices cannot be sanitized appropriately for intraoperative use without damage to the device. In addition, most exophthalmometers are designed to be used with the patient upright rather than supine as they are during surgery. Until the development of the present devices, surgeons typically have relied on visual assessment of exophthalmos or enophthalmos during surgery to decide the extent of surgery, which can lead to over correction or under correction of exophthalmos or enophthalmos.

[00162] The devices described herein may be fabricated with a biocompatible metal, resin, or plastic that is autoclavable and can withstand sterilization procedures. In addition, these devices are designed to be used conveniently during surgery with a patient in a supine position. The use of these devices will augment surgeons' qualitative visual estimations with quantitative measurements, making surgical procedures easier for surgeons to conduct and outcomes more precise and satisfactory for patients. In addition, the devices can be produced inexpensively and designed for single-use, which will reduce the burden on sterile processing departments, as the device may be discarded once a surgery is completed.

Examples of Non-Limiting Aspects of the Disclosure

[00163] Aspects, including embodiments, of the present subject matter described above may be beneficial alone or in combination, with one or more other aspects or embodiments. Without limiting the foregoing description, certain non-limiting aspects of the disclosure numbered 1 -122 are provided below. As will be apparent to those of skill in the art upon reading this disclosure, each of the individually numbered aspects may be used or combined with any of the preceding or following individually numbered aspects. This is intended to provide support for all such combinations of aspects and is not limited to combinations of aspects explicitly provided below.

1 . A device for measuring exophthalmos or enophthalmos, the device comprising: a base comprising a chamber; a chamber tip bulb attached to the bottom of the base, wherein the chamber tip bulb can be positioned on a lateral orbital rim of an eye of a patient; a slidable arm comprising a first end comprising a base attachment element and a second end comprising an eye rest element, wherein the base attachment element fits inside a complementary receiving location of the chamber to adjustably attach the slidable arm to the base such that the slidable arm projects orthogonally away from the base, wherein the base attachment element is moveable along the chamber vertically to allow the slidable arm to slide along the vertical length of the base until the eye rest element of the slidable arm rests on the eye of the patient to permit measurement of the exophthalmos or enophthalmos of the eye; and a measuring element on the base, wherein the measuring element can be used to measure distance between the lateral orbital rim and the eye rest element of the slidable arm when the eye rest element rests on the eye of the patient to determine the exophthalmos or enophthalmos of the eye.

2. The device of aspect 1 , wherein the measuring element is an embossed ruler on an exterior surface of the base. 3. The device of aspect 1 or 2, wherein the measuring element is calibrated to zero at the lateral orbital rim.

4. The device of any one of aspects 1 -3, wherein the measuring element measures the distance in millimeters.

5. The device of any one of aspects 1 -4, wherein the chamber tip bulb is indented at the bottom at the end distal to the chamber.

6. The device of any one of aspects 1 -5, wherein the chamber tip bulb further comprises a downward projection at the end distal to the chamber, wherein the downward projection can hook the lateral orbital rim.

7. The device of any one of aspects 1 -6, wherein the device further comprises a built-in level to allow a user to keep the device horizontally aligned to accurately measure the exophthalmos or enophthalmos of the eye.

8. The device of aspect 7, wherein the level is a bubble level.

9. The device of aspect 7, wherein the level comprises a cylinder that is filled with a liquid up to an engraved line.

10. The device of aspect 9, wherein the liquid is water.

11 . The device of any one of aspects 7 or 8, wherein the level is spherical.

12. The device of any one of aspects 7-1 1 , wherein the level is located on top of the slidable arm or the base.

13. The device of any one of aspects 12, wherein the level is inside a cylindrical indent in an eye contact area on top of the slidable arm. 14. The device of any one of aspects 1-13, wherein the eye rest element of the slidable arm is narrow enough to fit within an interpalpebral fissure and contact the cornea.

15. The device of any one of aspects 1 -14, wherein the eye rest element has a width of less than or equal to 8 mm.

16. The device of any one of aspects 1 -15, wherein the eye rest element can rest on an eyelid or cornea of the eye.

17. The device of any one of aspects 1-16, wherein the slidable arm has a dovetail-square hybrid shape.

18. The device of any one of aspects 1 -17, wherein the base and the slidable arm further comprise chamfers.

19. The device of any one of aspects 1 -18, wherein the slidable arm can slide a distance of up to 30 mm along the vertical length of the base.

20. The device of any one of aspects 1-19, wherein the slidable arm contacts an ocular surface and an eyelid when the eye rest element of the slidable arm rests on the eye of the patient.

21. The device of any one of aspects 1 -20, wherein the base further comprises an attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the attachment interface, wherein each chamber tip bulb of the plurality comprises different contact points.

22. The device of aspect 21 , wherein the attachment interface comprises a slot for receiving one of the plurality of chamber tip bulbs, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot to allow the plurality of chamber tip bulbs to be switched to change the contact points.

23. The device of aspect 21 or 22, wherein the contact points comprise Hertel-like or Naugle-like contact points. 24. The device of any one of aspects 1-23, wherein the chamber tip bulb comprises contact points above and below the superior orbital rim, above and below the inferior orbital rim, on the lateral orbital rim, on the lateral orbital wall, or any combination thereof.

25. The device of any one of aspects 1-24, wherein the chamber tip bulb further comprises inferior protrusions.

26. The device of any one of aspects 1 -25, wherein the base further comprises an attachment interface for attachment to a modular level that is removably attachable via the attachment interface.

27. The device of aspect 26, wherein the base further comprises a cutout at the top of the first chamber, wherein the modular level can be slid into the cutout at the top of the chamber.

28. The device of any one of aspects 1 -27, wherein the slidable arm has a width in a range from 8 mm to 20 mm.

29. The device of any one of aspects 1 -28, wherein the slidable arm further comprises a reinforcement spine.

30. The device of any one of aspects 1 -29, wherein the base further comprises a lever to control movement of the base attachment element of the slidable arm along the chamber vertically.

31 . The device of any one of aspects 1 -30, wherein the slidable arm further comprises a locking mechanism such that the base attachment element is moveable along the chamber vertically and lockable at a selected position.

32. The device of any one of aspects 1 -31 , wherein the base further comprises a horizontal push rod, wherein the horizontal push rod is located below the measuring element along an axis orthogonal to the measuring element. 33. The device of aspect 32, wherein the horizontal push rod comprises a locking mechanism, wherein pushing the horizontal push rod down locks the horizontal push rod in place.

34. The device of aspect 32 or 33, wherein the horizontal push rod contacts the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos.

35. The device of any one of aspects 1 -34, wherein the device comprises a biocompatible and autoclavable resin or plastic.

36. The device of aspect 35, wherein the resin or plastic is compatible with three- dimensional (3D)-printing of the device.

37. The device of aspect 35 or 36, wherein the resin or plastic comprises a methacrylic acid ester.

38. The device of any one of aspects 35-37, wherein the resin or plastic is a photoreactive resin or plastic.

39. The device of any one of aspects 1 -38, wherein the device comprises a metal.

40. The device of aspect 37, wherein the metal is stainless steel, carbon steel, titanium or a titanium alloy, or aluminum.

41 . The device of any one of aspects 1 -38, wherein the device is designed for single-use.

42. The device of any one of aspects 1 -38, wherein the device is designed for multiple uses.

43. The device of any one of aspects 1-38, wherein the device is modular, wherein the chamber is designed for multiple uses, and wherein the chamber tip bulb and the slidable arm are designed for single use. 44. The device of aspect 43, wherein the chamber comprises a metal, and wherein the chamber tip bulb and the slidable arm comprise a plastic or a resin.

45. The device of any one of aspects 1 -44, wherein regions of the device that contact the patient's face have rounded edges.

46. The device of any one of aspects 1 -45, further comprising a slot at the top of the chamber, said slot having a tapered thickness, wherein modular attachments can be inserted into the slot.

47. The device of aspect 46, further comprising a modular level, wherein the modular level can be inserted into the slot.

48. The device of any one of aspects 1 -47, wherein the slidable arm further comprises a hole to allow a first reference dot to be marked on the face of the patient, and wherein the chamber further comprises a hook to allow a second reference dot to be marked on the face of the patient.

49. A method of using the device of any one of aspects 1 -48 for measuring exophthalmos or enophthalmos, the method comprising: positioning the device of any one of aspects 1 -48 on the face of a patient such that the eye rest element is over an eye; lowering the slidable arm until the eye rest element rests on the eye of the patient; and measuring exophthalmos or enophthalmos of the eye using the measuring element.

50. The method of aspect 49, wherein the patient has thyroid eye disease, orbital cellulitis, dacryoadenitis, Erdheim-Chester disease, mucormycosis, an orbital pseudotumor, high-altitude cerebral edema, granulomatosis with polyangiitis, nasopharyngeal angiofibroma, Hand-Schuller- Christian disease, capillary hemangioma, cavernous hemangioma, a dermoid cyst, aortic insufficiency, orbital fracture, retrobulbar hemorrhage, carotid-cavernous fistulas, Cushing’s syndrome, craniosynostosis, Crouzon syndrome, Pfeiffer syndrome, pansynostosis, orbital varix, an orbital lymphatic malformation, pseudoenophthalmos, facial asymmetry, contralateral proptosis, microphthalmos, ptosis, cranialstenosis, granulomatosis with polyangiitis (Wegener’s granulomatosis), idiopathic orbital inflammation, tuberculosis, orbital myositis, atypical mycobacterial infection, a vascular anomaly, exposure to pressure, an iatrogenic injury, radiotherapy, cavernous sinus thrombosis, an orbital neoplasm, orbital metastasis, metastatic neuroblastoma, scirrhous breast carcinoma, gastric carcinoma, lung carcinoma, rhabdomyosarcoma, an epithelial cyst, glioma of the optic nerve, meningioma, orbital extension of retinoblastoma, orbital lymphoma, leukemia, mucocele, lacrimal gland tumor, structural abnormality, paranasal sinus mucoceles, maxillary sinus disease, chronic maxillary sinusitis, silent sinus syndrome, maxillary hypoplasia, absence of the greater sphenoid wing, neurofibromatosis, an orbital bony defect, congenital bony orbital asymmetry, congenital fibrosis of the extraocular muscles (CFEOM), Paget’s disease, fat atrophy, senile enophthalmos, lipodystrophy, scleroderma, Parry-Romberg syndrome, blue rubber bleb naevus syndrome, schizophrenia, Leber’s congenital amaurosis, Cockayne’s dystropyhy, hydrocephalus and V-P shunt, restrictive myopathy, Duane’s retraction syndrome, sarcoidosis, primary orbital leiomyoma, posterior traction secondary to fibrosis of the extraocular muscles or connective tissues, trisomy 9p, trisomy 7q, or Horner’s syndrome.

51 . The method of aspect 49 or 50, wherein said measuring is performed during ocular surgery.

52. The method of aspect 51 , wherein the ocular surgery comprises orbital fracture repair or orbital decompression.

53. The method of aspect 51 or 52, wherein exophthalmos or enophthalmos of the eye is measured multiple times during the ocular surgery using the device.

54. The method of any one of aspects 51 -53, further comprising measuring exophthalmos or enophthalmos of the eye with the device before the ocular surgery, after the ocular surgery, or a combination thereof.

55. The method of one of aspects 51 -54, further comprising sterilizing the device prior to performing the ocular surgery.

56. The method of one of aspects 49-55, wherein said measuring comprises measuring distance between the corneal apex and the lateral orbital rim. 57. The method of one of aspects 49-56, wherein after said measuring exophthalmos or enophthalmos of the eye, the method further comprises: positioning the device on the face of the patient such that the eye rest element is over the other eye of the patient; lowering the slidable arm until the eye rest element rests on the other eye of the patient; and measuring exophthalmos or enophthalmos of the other eye using the measuring element.

58. The method of any one of aspects 49-57, further comprising measuring difference in the exophthalmos or enophthalmos of each eye.

59. The method of any one of aspects 49-58, wherein the patient is in a supine position.

60. A kit comprising the device of any one of aspects 1 -48 and instructions for measuring exophthalmos or enophthalmos with the device.

61 . The kit of aspect 60, wherein the device is sterilized and contained in a packaging comprising a sterile compartment for holding the device.

62. A bilateral device for measuring exophthalmos or enophthalmos, the device comprising: a first base comprising a first chamber and a second base comprising a second chamber; a first chamber tip bulb attached to the bottom of the first base, wherein the first chamber tip bulb can be positioned on a first lateral orbital rim of a first eye of a patient and a second chamber tip bulb attached to the bottom of the second base, wherein the second chamber tip bulb can be positioned on a second lateral orbital rim of a second eye of the patient; a first slidable arm comprising a first end comprising a first base attachment element and a second end comprising a first eye rest element, wherein the first base attachment element fits inside a first complementary receiving location of the first chamber to adjustably attach the first slidable arm to the first base such that the first slidable arm projects orthogonally away from the first base, wherein the first base attachment element is moveable along the first chamber vertically to allow the first slidable arm to slide along the vertical length of the first base until the first eye rest element of the first slidable arm rests on the first eye of the patient to permit measurement of the exophthalmos or enophthalmos of the first eye; a second slidable arm comprising a first end comprising a second base attachment element and a second end comprising a second eye rest element, wherein the second base attachment element fits inside a second complementary receiving location of the second chamber to adjustably attach the second slidable arm to the second base such that the second slidable arm projects orthogonally away from the second base, wherein the second base attachment element is moveable along the second chamber vertically to allow the second slidable arm to slide along the vertical length of the second base until the second eye rest element of the second slidable arm rests on the second eye of the patient to permit measurement of the exophthalmos or enophthalmos of the second eye; a first measuring element on the first base, wherein the first measuring element can be used to measure distance between the first lateral orbital rim and the first eye rest element of the first slidable arm when the first eye rest element rests on the first eye of the patient to determine the exophthalmos or enophthalmos of the first eye; a second measuring element on the second base, wherein the second measuring element can be used to measure distance between the second lateral orbital rim and the second eye rest element of the second slidable arm when the second eye rest element rests on the second eye of the patient to determine the exophthalmos or enophthalmos of the second eye; and a bridge comprising a nose piece, wherein the bridge connects the first base to the second base, and wherein the nose piece contacts the nose bridge of the patient when the device is placed on the patient.

63. The device of aspect 62, wherein the first measuring element is a first embossed ruler on an exterior surface of the first base and the second measuring element is a second embossed ruler on an exterior surface of the second base.

64. The device of aspect 62 or 63, wherein the first measuring element is calibrated to zero at the first lateral orbital rim and the second measuring element is calibrated to zero at the second lateral orbital rim.

65. The device of any one of aspects 62-64, wherein the first measuring element and the second measuring element measure the distance in millimeters. 66. The device of any one of aspects 62-65, wherein the first chamber tip bulb is indented at the bottom at the end distal to the first chamber and the second chamber tip bulb is indented at the bottom of the end distal to the second chamber.

67. The device of any one of aspects 62-65, wherein the first chamber tip bulb further comprises a first downward projection at the end distal to the first chamber, wherein the first downward projection can hook the first lateral orbital rim, and the second chamber tip bulb further comprises a second downward projection at the end distal to the second chamber, wherein the second downward projection can hook the second lateral orbital rim.

68. The device of any one of aspects 62-67, wherein the device further comprises a built- in level to allow a user to keep the device horizontally aligned to accurately measure the exophthalmos or enophthalmos of the eye.

69. The device of aspect 68, wherein the level is a bubble level.

70. The device of aspect 68, wherein the level comprises a cylinder that is filled with a liquid up to an engraved line.

71 . The device of aspect 70, wherein the liquid is water.

72. The device of aspect 68 or 69, wherein the level is spherical.

73. The device of any one of aspects 68-72, wherein the level is located on top of the first or second slidable arm, the first or second base, or the bridge.

74. The device of aspect 73, wherein the level is inside a cylindrical indent in an eye contact area on top of the first or second slidable arm.

75. The device of any one of aspects 62-74, wherein the first eye rest elements is narrow enough to fit within an interpalpebral fissure of the first eye and contact the cornea of the first eye, and the second eye rest element is narrow enough to fit within an interpalpebral fissure of the second eye and contact the cornea of the second eye. 76. The device of aspect 75, wherein the first eye rest element and the second eye rest element have a width of less than or equal to 8 mm.

77. The device of any one of aspects 62-76, wherein he first eye rest element and the second eye rest element can rest on an eyelid or cornea of the eye.

78. The device of any one of aspects 62-77, wherein the first slidable arm and the second slidable arm have a dovetail-square hybrid shape.

79. The device of any one of aspects 62-78, wherein the first and second bases and the first and second slidable arms further comprise chamfers.

80. The device of any one of aspects 62-79, wherein the first slidable arm can slide a distance of up to 30 mm along the vertical length of the first base, and the second slidable arm can slide a distance of up to 30 mm along the vertical length of the second base.

81 . The device of any one of aspects 62-80, wherein the first slidable arm contacts a first ocular surface and eyelid when the first eye rest element of the first slidable arm rests on the first eye of the patient, and the second slidable arm contacts a second ocular surface and eyelid when the second eye rest element of the second slidable arm rests on the second eye of the patient.

82. The device of any one of aspects 62-81 , wherein the first base further comprises a first attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the first attachment interface, and wherein the second base further comprises a second attachment interface for attachment to another one of the plurality of chamber tip bulbs that are removably attachable via the second attachment interface.

83. The device of aspect 82 wherein the chamber tip bulbs attached to the first base and the second base have the same contact points or different contact points.

84. The device of aspect 82 or 83, wherein the first and second attachment interfaces each comprise a slot for receiving one of the plurality of chamber tip bulbs, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot to allow the plurality of chamber tip bulbs to be switched to change the contact points.

85. The device of any one of aspects 82-84, wherein the contact points comprise Hertel- like or Naugle-like contact points.

86. The device of any one of aspects 62-85, wherein the first and second chamber tip bulbs further comprise inferior protrusions.

87. The device of any one of aspects 62-86, wherein the first chamber tip bulb comprises contact points above and below the superior orbital rim of the first eye, above and below the inferior orbital rim of the first eye, on the lateral orbital rim of the first eye, on the lateral orbital wall or the first eye, or any combination thereof, and the second chamber tip bulb comprises contact points above and below the superior orbital rim of the second eye, above and below the inferior orbital rim of the second eye, on the lateral orbital rim of the second eye, on the lateral orbital wall or the second eye, or any combination thereof.

88. The device of any one of aspects 62-87, wherein, the first base and/or the second base further comprise an attachment interface for attachment to a modular level that is removably attachable via the attachment interface.

89. The device of aspect 88, wherein the first base further comprises a first cutout at the top of the first chamber, wherein the modular level can be slid into the first cutout at the top of the first chamber, and wherein the second base further comprises a second cutout at the top of the second chamber, wherein the modular level can be slid into the second cutout at the top of the second chamber.

90. The device of any one of aspects 62-89, wherein the first and second slidable arms have a width in a range from 8 mm to 20 mm.

91 . The device of any one of aspects 62-90, wherein the first and second slidable arms each further comprise a reinforcement spine. 92. The device of any one of aspects 62-91 , wherein the first base further comprises a first lever to control movement of the first base attachment element of the first slidable arm along the first chamber vertically, and the second base further comprises a second lever to control movement of the second base attachment element of the second slidable arm along the second chamber vertically.

93. The device of any one of aspects 62-92, wherein the first slidable arm further comprises a first locking mechanism such that the first base attachment element is moveable along the first chamber vertically and lockable at a first selected position, and the second slidable arm further comprises a second locking mechanism such that the second base attachment element is moveable along the second chamber vertically and lockable at a second selected position.

94. The device of any one of aspects 62-93, wherein the first base further comprises a first horizontal push rod, wherein the first horizontal push rod is located below the first measuring element along an axis orthogonal to the first measuring element, and the second base further comprises a second horizontal push rod, wherein the second horizontal push rod is located below the second measuring element along an axis orthogonal to the second measuring element.

95. The device of aspect 94, wherein the first horizontal push rod comprises a first locking mechanism, wherein pushing the first horizontal push rod down locks the first horizontal push rod in place, and the second horizontal push rod comprises a second locking mechanism, wherein pushing the second horizontal push rod down locks the second horizontal push rod in place.

96. The device of aspect 94 or 95, wherein the first horizontal push rod and the second horizontal push rod contact the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos.

97. The device of any one of aspects 62-96, wherein the device comprises a biocompatible and autoclavable resin or plastic.

98. The device of aspect 97, wherein the resin or plastic is compatible with three- dimensional (3D)-printing of the device. 99. The device of aspect 97 or 98, wherein the resin or plastic comprises a methacrylic acid ester.

100. The device of any one of aspects 97-99, wherein the resin or plastic is a photoreactive resin or plastic.

101. The device of any one of aspects 62-96, wherein the device comprises a metal.

102. The device of aspect 101 , wherein the metal is stainless steel, carbon steel, titanium or a titanium alloy, or aluminum.

103. The device of any one of aspects 62-102, wherein the device is designed for singleuse.

104. The device of any one of aspects 62-103, wherein the device is designed for multiple uses.

105. The device of any one of aspects 62-104, wherein the device is modular, wherein the first chamber and the second chamber are designed for multiple uses, and wherein the first and second chamber tip bulbs and the first and second slidable arms are designed for single use.

106. The device of aspect 105, wherein the first chamber and the second chamber comprise a metal, and wherein the first and second chamber tip bulbs and the first and second slidable arms comprise a plastic or a resin.

107. The device of any one of aspects 62-106, wherein regions of the device that contact the patient's face have rounded edges.

108. The device of any one of aspects 62-107, further comprising a first slot at the top of the first chamber and a second slot at the top of the second chamber, each slot having a tapered thickness, wherein modular attachments can be inserted into the first slot and the second slot. 109. The device of aspect 108, further comprising a modular level, wherein the modular level can be inserted into the first slot or the second slot.

110. The device of any one of aspects 62-109, wherein the first and second slidable arms each further comprise a hole to allow a first reference dot to be marked on the face of the patient, and wherein the first and second chambers each further comprise a hook to allow a second reference dot to be marked on the face of the patient.

11 1. A method of using the device of any one of aspects 62-110 for measuring exophthalmos or enophthalmos, the method comprising: positioning the device of any one of aspects 58-102 on the face of the patient such that the first eye rest element is over the first eye and the second eye rest element is over the second eye; lowering the first slidable arm until the first eye rest element rests on the first eye of the patient; lowering the second slidable arm until the second eye rest element rests on the second eye of the patient; measuring exophthalmos or enophthalmos of the first eye using the first measuring element; and measuring exophthalmos or enophthalmos of the second eye using the second measuring element.

112. The method of aspect 111 , wherein the patient has thyroid eye disease, orbital cellulitis, dacryoadenitis, Erdheim-Chester disease, mucormycosis, an orbital pseudotumor, high- altitude cerebral edema, granulomatosis with polyangiitis, nasopharyngeal angiofibroma, Hand- Schuller-Christian disease, capillary hemangioma, cavernous hemangioma, a dermoid cyst, aortic insufficiency, orbital fracture, retrobulbar hemorrhage, carotid-cavernous fistulas, Cushing’s syndrome, craniosynostosis, Crouzon syndrome, Pfeiffer syndrome, pansynostosis, orbital varix, an orbital lymphatic malformation, pseudoenophthalmos, facial asymmetry, contralateral proptosis, microphthalmos, ptosis, cranialstenosis, granulomatosis with polyangiitis (Wegener’s granulomatosis), idiopathic orbital inflammation, tuberculosis, orbital myositis, atypical mycobacterial infection, a vascular anomaly, exposure to pressure, an iatrogenic injury, radiotherapy, cavernous sinus thrombosis, an orbital neoplasm, orbital metastasis, metastatic neuroblastoma, scirrhous breast carcinoma, gastric carcinoma, lung carcinoma, rhabdomyosarcoma, an epithelial cyst, glioma of the optic nerve, meningioma, orbital extension of retinoblastoma, orbital lymphoma, leukemia, mucocele, lacrimal gland tumor, structural abnormality, paranasal sinus mucoceles, maxillary sinus disease, chronic maxillary sinusitis, silent sinus syndrome, maxillary hypoplasia, absence of the greater sphenoid wing, neurofibromatosis, an orbital bony defect, congenital bony orbital asymmetry, congenital fibrosis of the extraocular muscles (CFEOM), Paget’s disease, fat atrophy, senile enophthalmos, lipodystrophy, scleroderma, Parry-Romberg syndrome, blue rubber bleb naevus syndrome, schizophrenia, Leber’s congenital amaurosis, Cockayne’s dystropyhy, hydrocephalus and V-P shunt, restrictive myopathy, Duane’s retraction syndrome, sarcoidosis, primary orbital leiomyoma, posterior traction secondary to fibrosis of the extraocular muscles or connective tissues, trisomy 9p, trisomy 7q, or Horner’s syndrome.

113. The method of aspect 111 or 112, wherein said measuring exophthalmos or enophthalmos of the first eye and the second eye is performed during ocular surgery.

114. The method of aspect 113, wherein the ocular surgery comprises orbital fracture repair or orbital decompression.

115. The method of aspect 113 or 114, wherein exophthalmos or enophthalmos of the first eye and the second eye is measured multiple times during the ocular surgery using the device.

116. The method of any one of aspects 1 13-115, further comprising measuring exophthalmos or enophthalmos of the first eye and the second eye with the device before the ocular surgery, after the ocular surgery, or a combination thereof.

117. The method of any one of aspects 113-116, further comprising sterilizing the device prior to performing the ocular surgery.

118. The method of any one of aspects 1 11-117, wherein said measuring exophthalmos or enophthalmos of the first eye comprises measuring distance between the corneal apex and the lateral orbital rim of the first eye, and said measuring exophthalmos or enophthalmos of the second eye comprises measuring distance between the corneal apex and the lateral orbital rim of the second eye. 119. The method of any one of aspects 111 -118, further comprising measuring difference in the exophthalmos or enophthalmos of the first eye and the second eye.

120. The method of any one of aspects 1 11 -119, wherein the patient is in a supine position.

121. A kit comprising the device of any one of aspects 62-110 and instructions for measuring exophthalmos or enophthalmos with the device.

122. The kit of aspect 121 , wherein the device is sterilized and contained in a packaging comprising a sterile compartment for holding the device.

[00164] It will be apparent to one of ordinary skill in the art that various changes and modifications can be made without departing from the spirit or scope of the invention.

EXPERIMENTAL

[00165] The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to make and use the present invention, and are not intended to limit the scope of what the inventors regard as their invention nor are they intended to represent that the experiments below are all or the only experiments performed. Efforts have been made to ensure accuracy with respect to numbers used (e.g. amounts, temperature, etc.) but some experimental errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, molecular weight is weight average molecular weight, temperature is in degrees Centigrade, and pressure is at or near atmospheric.

[00166] All publications and patent applications cited in this specification are herein incorporated by reference as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

[00167] The present invention has been described in terms of particular embodiments found or proposed by the present inventor to comprise preferred modes for the practice of the invention. It will be appreciated by those of skill in the art that, in light of the present disclosure, numerous modifications and changes can be made in the particular embodiments exemplified without departing from the intended scope of the invention. All such modifications are intended to be included within the scope of the appended claims. Example 1

Intra-Operative Exophthalmometer

[00168] Here, we describe an intra-operative exophthalmometer designed to measure exophthalmos or enophthalmos of an eye. The exophthalmometer can be printed with a 3D-printer using a biocompatible resin (Biomed Clear) typically used for producing implants. The exophthalmometer has a simple, single-use design that can be sterilized and safely used on patients during surgery in order to take serial measurements before and throughout the surgery. The primary use of this exophthalmometer is for orbital fracture repair or orbital decompression surgeries.

[00169] Our design is unique in that it can be autoclaved as per standard sanitization protocols for use in the operating room. This will augment surgeons¹ qualitative visual estimations with quantitative measurements, making surgical procedures easier for surgeons to conduct and outcomes more precise and satisfactory for patients. In addition, the low-cost, single-use nature of our design reduces the burden on sterile processing departments as the device may be discarded once the surgery is completed.

Version 1 .2

[00170] FIG. 3 shows version 1 .2 of the exophthalmometer, which comprises an arm, chamber, base, and brake, as illustrated. With this version of the exophthalmometer, we found it difficult to place the base pillar because patients are draped in the operating room. Another disadvantage of this model was the cost of the material to make the exophthalmometer.

Version 2.3

[00171] FIG. 4 shows version 2.3 of the exophthalmometer. In this version, the base attachments of version 1 .2 were removed to create a smaller design having less material, which reduces the cost of production. Arm protrusions were added to make reading measurements easier. With this version, it was difficult to keep the device grounded to the same spot. In addition, problems with vertical wiggle caused inaccurate measurements.

Version 4.1

[00172] FIG. 5 shows version 4.1 of the exophthalmometer, which has the following improvements over version 2.3: a dovetail cut for stability, a thicker arm, a chamber tip bulb (rests better on lateral orbital rim), and lowered arm protrusions (change origin point). With this version, gluing a paper ruler added an extra step to production, and the arm and chamber did not slide smoothly resulting in frequent jamming.

Version 4.3

[00173] FIG. 6 shows version 4.3 of the exophthalmometer. This version added an embossed ruler and a shrunken chamber for prototyping, which reduce material usage while adjusting tolerances. With this version, measurements were not calibrated to zero at the orbital rim of the patient.

Version 4.5

[00174] FIG. 7 shows version 4.5 of the exophthalmometer. This version has an indented chamber tip bulb, which changes the origin point. This improvement allows measurements to be calibrated to zero at the orbital rim of the patient. With this version, the dovetail cut slips forward causing the device to jam despite precisely drawn tolerances.

Version 5.0

[00175] FIG. 8 shows version 5.0 of the exophthalmometer. This version improves on version 4.5 by having a dovetail/square hybrid cut, which prevents jamming. However, this version had many "floating" sections that were difficult to print, no matter the orientation, and needed more support structures, which wasted material, and had rough edges where supports were easily broken off.

Version 5.5

[00176] FIG. 9 shows version 5.5 of the exophthalmometer. This version improves on version 5.0 by having chamfers (eliminating 90° overhangs) for printing practicality. In this version, there were still problems with the arm wiggling despite multiple thickness increases and printing difficulties.

Version 6.2

[00177] FIG. 10 shows version 6.2 of the exophthalmometer. This version improves on version 5.5 by having additional chamfers and a reinforcement spine. Version 6.4

[00178] FIG. 11 shows version 6.4 of the exophthalmometer. This version improves on version 6.2 by re-extending the chamber to a 30 mm working range and using a taller arm block with less vertical wiggle.

[00179] This version was used as a prototype to take intraoperative measurements of proptosis during a unilateral orbital decompression operation. The forward protrusion of the eye of the patient as measured with this version of the exophthalmometer was 27 mm at the start of surgery and 22 mm at the end of surgery. A post-operative measurement with a Hertel exophthalmometer showed a 5 mm decrease in proptosis.

[00180] Version 6.4 of the exophthalmometer was found to be difficult to hold perpendicularly. Sliding of the tip bulb during attempts to take intraoperative measurements was another problem discovered during the surgery.

Version 7.1

[00181] FIG. 12 shows version 7.1 of the exophthalmometer. This version improves on version 6.4 by using a ruler in mm instead of cm, adding a built-in prototype level, having a reduced chamber tip bulb, which can hook to the orbital rim of a patient, and adding ergonomic cuts. One problem with producing this version was that hollow pieces are very difficult to print, cure, and clean.

Version 7.3.3

[00182] FIG. 13 shows version 7.3.3 of the exophthalmometer. This version improves on version 7.1 by using no hollow parts, which allows for easy curing and cleaning and having multi-part levels for printing practicality.

Further Optimization of the Exophthalmometer

[00183] We are further optimizing the exophthalmometer in various ways, including fine tuning the bubble level, changing the width of the arm to 8 mm, which allows for contact with the ocular surface as well as the eyelid (FIG. 22); and adding a thumb lever to provide easier manipulation of the arm while holding the chamber stabile (FIG. 23). The chamber can be redesigned to use other reference points in cases where the lateral orbital rim of a patient is inaccessible or will be altered in surgery.

[00184] To produce a bilateral measuring tool (FIG. 2), a bridge is added. In this version, the exophthalmometer contacts the nose bridge and both lateral orbital rims to allow intraoperative measurements of both eyes of the patient without moving the device from one eye to the other. [00185] As shown in FIG. 24, the device can be designed with modular contact points such as Hertel- inspired or Naugle-inspired contact points. FIG. 27 shows a modular piece having "Naugle-like" reference contact points and inferior protrusions.

[00186] A level can be added to the device as shown in FIG. 25. A cylinder, attached to the top of the base, is filled with water up to an engraved line to serve as a spirit level. In another exemplary embodiment, shown in FIG. 18, the exophthalmometer comprises a small spherical level placed inside a cylindrical indent of the eye contact area. The level may be covered with a glass slide.

[00187] A horizontal push rod can be added to the device, as shown in FIG. 26, to provide an additional point of contact with a patient’s face. The horizontal push rod moves along an axis orthogonal to the ruler. The rod can be pushed down to lock it in place.

[00188] FIGS. 28A-28D show an exemplary modular exophthalmometer having a cutout at the top of the chamber and a slot at the bottom in which modular pieces can be slid in. For example, a modular level can be slid into the cutout at the top of the chamber, and a chamber tip bulb with either Hertel- inspired or Naugle-inspired contact points may be slid into the slot at the bottom of the base. FIGS. 28A-28D illustrate how the modular pieces can be assembled in the exophthalmometer. FIG. 28A shows the base with the modular level and chamber tip bulb with Naugle-inspired contact points positioned to be slid into the base. FIG. 28B shows the base with the modular level and chamber tip bulb with Hertel-inspired contact points positioned to be slid into the base. FIG. 28C shows the base with the modular level and chamber tip bulb with Naugle-inspired contact points slid into the base. FIG. 28D shows the base with the modular level and chamber tip bulb with Hertel-inspired contact points slid into the base.

[00189] FIG. 29 shows an exemplary exophthalmometer having the pieces that contact a patient's face during normal use designed with rounded edges to improve comfort.

[00190] FIG. 30 shows an exemplary exophthalmometer having a tapered thickness slot at the top part of the chamber that allows for extra modular attachments to be added. A level finder can be designed to fit in the slot, as depicted.

[00191] Holes can be added to an exophthalmometer at contact points to allow marking of reference points on the face of a patient. The holes are designed to have a diameter large enough to fit the tip of a marker through to allow a physician to place reference dots on the face of the patient to help provide consistency of reference point selection for measurements. FIG. 31 A shows an arm with a hole, which allows a surgeon to dot the point of measurement using a marking pen to provide for consistency of measurements. FIG. 31 B shows a chamber with a hook, which can also be used for marking the face of the patient prior to measurement. When marking the points of measurement, the hook can be colored on with a marker before use. When the hook contacts the patient's face, the residual ink on the hook leaves a dot on the patient's skin. Next, the sliding arm potion of the device is brought down to the level of the patient's eyelid to take the initial measurement. The surgeon can make a second dot through the hole in the arm of the device. After the surgery is completed, the tool can be aligned to these 2 dots once again to take a second set of measurements.

[00192] We aim to further reduce the cost of production, optimize printing speed of the 3D printer generating the exophthalmometer, and minimize the amount of material used to produce the exophthalmometer.

Claims

What is claimed is:

2. The device of claim 1 , wherein the measuring element is an embossed ruler on an exterior surface of the base.

3. The device of claim 1 or 2, wherein the measuring element is calibrated to zero at the lateral orbital rim.

4. The device of any one of claims 1 -3, wherein the measuring element measures the distance in millimeters.

5. The device of any one of claims 1 -4, wherein the chamber tip bulb is indented at the bottom at the end distal to the chamber.

6. The device of any one of claims 1 -5, wherein the chamber tip bulb further comprises a downward projection at the end distal to the chamber, wherein the downward projection can hook the lateral orbital rim.

7. The device of any one of claims 1-6, wherein the device further comprises a built-in level to allow a user to keep the device horizontally aligned to accurately measure the exophthalmos or enophthalmos of the eye.

8. The device of claim 7, wherein the level is a bubble level.

9. The device of claim 7, wherein the level comprises a cylinder that is filled with a liquid up to an engraved line.

10. The device of claim 9, wherein the liquid is water.

11 . The device of any one of claims 7 or 8, wherein the level is spherical.

12. The device of any one of claims 7-11 , wherein the level is located on top of the slidable arm or the base.

13. The device of any one of claims 12, wherein the level is inside a cylindrical indent in an eye contact area on top of the slidable arm.

14. The device of any one of claims 1 -13, wherein the eye rest element of the slidable arm is narrow enough to fit within an interpalpebral fissure and contact the cornea.

15. The device of any one of claims 1 -14, wherein the eye rest element has a width of less than or equal to 8 mm.

16. The device of any one of claims 1 -15, wherein the eye rest element can rest on an eyelid or cornea of the eye.

17. The device of any one of claims 1 -16, wherein the slidable arm has a dovetail-square hybrid shape.

18. The device of any one of claims 1-17, wherein the base and the slidable arm further comprise chamfers.

19. The device of any one of claims 1-18, wherein the slidable arm can slide a distance of up to 30 mm along the vertical length of the base.

20. The device of any one of claims 1 -19, wherein the slidable arm contacts an ocular surface and an eyelid when the eye rest element of the slidable arm rests on the eye of the patient.

21. The device of any one of claims 1-20, wherein the base further comprises an attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the attachment interface, wherein each chamber tip bulb of the plurality comprises different contact points.

22. The device of claim 21 , wherein the attachment interface comprises a slot for receiving one of the plurality of chamber tip bulbs, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot to allow the plurality of chamber tip bulbs to be switched to change the contact points.

23. The device of claim 21 or 22, wherein the contact points comprise Hertel-like or Naugle-like contact points.

24. The device of any one of claims 1 -23, wherein the chamber tip bulb comprises contact points above and below the superior orbital rim, above and below the inferior orbital rim, on the lateral orbital rim, on the lateral orbital wall, or any combination thereof.

25. The device of any one of claims 1 -24, wherein the chamber tip bulb further comprises inferior protrusions.

26. The device of any one of claims 1-25, wherein the base further comprises an attachment interface for attachment to a modular level that is removably attachable via the attachment interface.

27. The device of claim 26, wherein the base further comprises a cutout at the top of the first chamber, wherein the modular level can be slid into the cutout at the top of the chamber.

28. The device of any one of claims 1 -27, wherein the slidable arm has a width in a range from 8 mm to 20 mm.

29. The device of any one of claims 1 -28, wherein the slidable arm further comprises a reinforcement spine.

30. The device of any one of claims 1-29, wherein the base further comprises a lever to control movement of the base attachment element of the slidable arm along the chamber vertically.

31 . The device of any one of claims 1 -30, wherein the slidable arm further comprises a locking mechanism such that the base attachment element is moveable along the chamber vertically and lockable at a selected position.

32. The device of any one of claims 1 -31 , wherein the base further comprises a horizontal push rod, wherein the horizontal push rod is located below the measuring element along an axis orthogonal to the measuring element.

33. The device of claim 32, wherein the horizontal push rod comprises a locking mechanism, wherein pushing the horizontal push rod down locks the horizontal push rod in place.

34. The device of claim 32 or 33, wherein the horizontal push rod contacts the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos.

35. The device of any one of claims 1 -34, wherein the device comprises a bio-compatible and autoclavable resin or plastic.

36. The device of claim 35, wherein the resin or plastic is compatible with three- dimensional (3D)-printing of the device.

37. The device of claim 35 or 36, wherein the resin or plastic comprises a methacrylic acid ester.

38. The device of any one of claims 35-37, wherein the resin or plastic is a photoreactive resin or plastic.

39. The device of any one of claims 1 -38, wherein the device comprises a metal.

40. The device of claim 37, wherein the metal is stainless steel, carbon steel, titanium or a titanium alloy, or aluminum.

41 . The device of any one of claims 1 -38, wherein the device is designed for single-use.

42. The device of any one of claims 1 -38, wherein the device is designed for multiple uses.

43. The device of any one of claims 1 -38, wherein the device is modular, wherein the chamber is designed for multiple uses, and wherein the chamber tip bulb and the slidable arm are designed for single use.

44. The device of claim 43, wherein the chamber comprises a metal, and wherein the chamber tip bulb and the slidable arm comprise a plastic or a resin.

45. The device of any one of claims 1-44, wherein regions of the device that contact the patient's face have rounded edges.

46. The device of any one of claims 1 -45, further comprising a slot at the top of the chamber, said slot having a tapered thickness, wherein modular attachments can be inserted into the slot.

47. The device of claim 46, further comprising a modular level, wherein the modular level can be inserted into the slot.

48. The device of any one of claims 1 -47, wherein the slidable arm further comprises a hole to allow a first reference dot to be marked on the face of the patient, and wherein the chamber further comprises a hook to allow a second reference dot to be marked on the face of the patient.

49. A method of using the device of any one of claims 1 -48 for measuring exophthalmos or enophthalmos, the method comprising: positioning the device of any one of claims 1 -48 on the face of a patient such that the eye rest element is over an eye; lowering the slidable arm until the eye rest element rests on the eye of the patient; and measuring exophthalmos or enophthalmos of the eye using the measuring element.

50. The method of claim 49, wherein the patient has thyroid eye disease, orbital cellulitis, dacryoadenitis, Erdheim-Chester disease, mucormycosis, an orbital pseudotumor, high-altitude cerebral edema, granulomatosis with polyangiitis, nasopharyngeal angiofibroma, Hand-Schuller- Christian disease, capillary hemangioma, cavernous hemangioma, a dermoid cyst, aortic insufficiency, orbital fracture, retrobulbar hemorrhage, carotid-cavernous fistulas, Cushing’s syndrome, craniosynostosis, Crouzon syndrome, Pfeiffer syndrome, pansynostosis, orbital varix, an orbital lymphatic malformation, pseudoenophthalmos, facial asymmetry, contralateral proptosis, microphthalmos, ptosis, cranialstenosis, granulomatosis with polyangiitis (Wegener’s granulomatosis), idiopathic orbital inflammation, tuberculosis, orbital myositis, atypical mycobacterial infection, a vascular anomaly, exposure to pressure, an iatrogenic injury, radiotherapy, cavernous sinus thrombosis, an orbital neoplasm, orbital metastasis, metastatic neuroblastoma, scirrhous breast carcinoma, gastric carcinoma, lung carcinoma, rhabdomyosarcoma, an epithelial cyst, glioma of the optic nerve, meningioma, orbital extension of retinoblastoma, orbital lymphoma, leukemia, mucocele, lacrimal gland tumor, structural abnormality, paranasal sinus mucoceles, maxillary sinus disease, chronic maxillary sinusitis, silent sinus syndrome, maxillary hypoplasia, absence of the greater sphenoid wing, neurofibromatosis, an orbital bony defect, congenital bony orbital asymmetry, congenital fibrosis of the extraocular muscles (CFEOM), Paget’s disease, fat atrophy, senile enophthalmos, lipodystrophy, scleroderma, Parry-Romberg syndrome, blue rubber bleb naevus syndrome, schizophrenia, Leber’s congenital amaurosis, Cockayne’s dystropyhy, hydrocephalus and V-P shunt, restrictive myopathy, Duane’s retraction syndrome, sarcoidosis, primary orbital leiomyoma, posterior traction secondary to fibrosis of the extraocular muscles or connective tissues, trisomy 9p, trisomy 7q, or Horner’s syndrome.

51 . The method of claim 49 or 50, wherein said measuring is performed during ocular surgery.

52. The method of claim 51 , wherein the ocular surgery comprises orbital fracture repair or orbital decompression.

53. The method of claim 51 or 52, wherein exophthalmos or enophthalmos of the eye is measured multiple times during the ocular surgery using the device.

54. The method of any one of claims 51-53, further comprising measuring exophthalmos or enophthalmos of the eye with the device before the ocular surgery, after the ocular surgery, or a combination thereof.

55. The method of one of claims 51-54, further comprising sterilizing the device prior to performing the ocular surgery.

56. The method of one of claims 49-55, wherein said measuring comprises measuring distance between the corneal apex and the lateral orbital rim.

57. The method of one of claims 49-56, wherein after said measuring exophthalmos or enophthalmos of the eye, the method further comprises: positioning the device on the face of the patient such that the eye rest element is over the other eye of the patient; lowering the slidable arm until the eye rest element rests on the other eye of the patient; and measuring exophthalmos or enophthalmos of the other eye using the measuring element.

58. The method of any one of claims 49-57, further comprising measuring difference in the exophthalmos or enophthalmos of each eye.

59. The method of any one of claims 49-58, wherein the patient is in a supine position.

60. A kit comprising the device of any one of claims 1 -48 and instructions for measuring exophthalmos or enophthalmos with the device.

61 . The kit of claim 60, wherein the device is sterilized and contained in a packaging comprising a sterile compartment for holding the device.

63. The device of claim 62, wherein the first measuring element is a first embossed ruler on an exterior surface of the first base and the second measuring element is a second embossed ruler on an exterior surface of the second base.

64. The device of claim 62 or 63, wherein the first measuring element is calibrated to zero at the first lateral orbital rim and the second measuring element is calibrated to zero at the second lateral orbital rim.

65. The device of any one of claims 62-64, wherein the first measuring element and the second measuring element measure the distance in millimeters.

66. The device of any one of claims 62-65, wherein the first chamber tip bulb is indented at the bottom at the end distal to the first chamber and the second chamber tip bulb is indented at the bottom of the end distal to the second chamber.

67. The device of any one of claims 62-65, wherein the first chamber tip bulb further comprises a first downward projection at the end distal to the first chamber, wherein the first downward projection can hook the first lateral orbital rim, and the second chamber tip bulb further comprises a second downward projection at the end distal to the second chamber, wherein the second downward projection can hook the second lateral orbital rim.

68. The device of any one of claims 62-67, wherein the device further comprises a built- in level to allow a user to keep the device horizontally aligned to accurately measure the exophthalmos or enophthalmos of the eye.

69. The device of claim 68, wherein the level is a bubble level.

70. The device of claim 68, wherein the level comprises a cylinder that is filled with a liquid up to an engraved line.

71 . The device of claim 70, wherein the liquid is water.

12.. The device of claim 68 or 69, wherein the level is spherical.

73. The device of any one of claims 68-72, wherein the level is located on top of the first or second slidable arm, the first or second base, or the bridge.

74. The device of claim 73, wherein the level is inside a cylindrical indent in an eye contact area on top of the first or second slidable arm.

75. The device of any one of claims 62-74, wherein the first eye rest elements is narrow enough to fit within an interpalpebral fissure of the first eye and contact the cornea of the first eye, and the second eye rest element is narrow enough to fit within an interpalpebral fissure of the second eye and contact the cornea of the second eye.

76. The device of claim 75, wherein the first eye rest element and the second eye rest element have a width of less than or equal to 8 mm.

77. The device of any one of claims 62-76, wherein he first eye rest element and the second eye rest element can rest on an eyelid or cornea of the eye.

78. The device of any one of claims 62-77, wherein the first slidable arm and the second slidable arm have a dovetail-square hybrid shape.

79. The device of any one of claims 62-78, wherein the first and second bases and the first and second slidable arms further comprise chamfers.

80. The device of any one of claims 62-79, wherein the first slidable arm can slide a distance of up to 30 mm along the vertical length of the first base, and the second slidable arm can slide a distance of up to 30 mm along the vertical length of the second base.

81 . The device of any one of claims 62-80, wherein the first slidable arm contacts a first ocular surface and eyelid when the first eye rest element of the first slidable arm rests on the first eye of the patient, and the second slidable arm contacts a second ocular surface and eyelid when the second eye rest element of the second slidable arm rests on the second eye of the patient.

82. The device of any one of claims 62-81 , wherein the first base further comprises a first attachment interface for attachment to one of a plurality of chamber tip bulbs that are removably attachable via the first attachment interface, and wherein the second base further comprises a second attachment interface for attachment to another one of the plurality of chamber tip bulbs that are removably attachable via the second attachment interface.

83. The device of claim 82 wherein the chamber tip bulbs attached to the first base and the second base have the same contact points or different contact points.

84. The device of claim 82 or 83, wherein the first and second attachment interfaces each comprise a slot for receiving one of the plurality of chamber tip bulbs, wherein each chamber tip bulb comprises an attachment element that is configured to slide into the slot to allow the plurality of chamber tip bulbs to be switched to change the contact points.

85. The device of any one of claims 82-84, wherein the contact points comprise Hertel- like or Naugle-like contact points.

86. The device of any one of claims 62-85, wherein the first and second chamber tip bulbs further comprise inferior protrusions.

87. The device of any one of claims 62-86, wherein the first chamber tip bulb comprises contact points above and below the superior orbital rim of the first eye, above and below the inferior orbital rim of the first eye, on the lateral orbital rim of the first eye, on the lateral orbital wall or the first eye, or any combination thereof, and the second chamber tip bulb comprises contact points above and below the superior orbital rim of the second eye, above and below the inferior orbital rim of the second eye, on the lateral orbital rim of the second eye, on the lateral orbital wall or the second eye, or any combination thereof.

88. The device of any one of claims 62-87, wherein, the first base and/or the second base further comprise an attachment interface for attachment to a modular level that is removably attachable via the attachment interface.

89. The device of claim 88, wherein the first base further comprises a first cutout at the top of the first chamber, wherein the modular level can be slid into the first cutout at the top of the first chamber, and wherein the second base further comprises a second cutout at the top of the second chamber, wherein the modular level can be slid into the second cutout at the top of the second chamber.

90. The device of any one of claims 62-89, wherein the first and second slidable arms have a width in a range from 8 mm to 20 mm.

91 . The device of any one of claims 62-90, wherein the first and second slidable arms each further comprise a reinforcement spine.

92. The device of any one of claims 62-91 , wherein the first base further comprises a first lever to control movement of the first base attachment element of the first slidable arm along the first chamber vertically, and the second base further comprises a second lever to control movement of the second base attachment element of the second slidable arm along the second chamber vertically.

93. The device of any one of claims 62-92, wherein the first slidable arm further comprises a first locking mechanism such that the first base attachment element is moveable along the first chamber vertically and lockable at a first selected position, and the second slidable arm further comprises a second locking mechanism such that the second base attachment element is moveable along the second chamber vertically and lockable at a second selected position.

94. The device of any one of claims 62-93, wherein the first base further comprises a first horizontal push rod, wherein the first horizontal push rod is located below the first measuring element along an axis orthogonal to the first measuring element, and the second base further comprises a second horizontal push rod, wherein the second horizontal push rod is located below the second measuring element along an axis orthogonal to the second measuring element.

95. The device of claim 94, wherein the first horizontal push rod comprises a first locking mechanism, wherein pushing the first horizontal push rod down locks the first horizontal push rod in place, and the second horizontal push rod comprises a second locking mechanism, wherein pushing the second horizontal push rod down locks the second horizontal push rod in place.

96. The device of claim 94 or 95, wherein the first horizontal push rod and the second horizontal push rod contact the face of the patient when the device is positioned on the face of the patient to measure exophthalmos or enophthalmos.

97. The device of any one of claims 62-96, wherein the device comprises a biocompatible and autoclavable resin or plastic.

98. The device of claim 97, wherein the resin or plastic is compatible with three- dimensional (3D)-printing of the device.

99. The device of claim 97 or 98, wherein the resin or plastic comprises a methacrylic acid ester.

100. The device of any one of claims 97-99, wherein the resin or plastic is a photoreactive resin or plastic.

101. The device of any one of claims 62-96, wherein the device comprises a metal.

102. The device of claim 101 , wherein the metal is stainless steel, carbon steel, titanium or a titanium alloy, or aluminum.

103. The device of any one of claims 62-102, wherein the device is designed for singleuse.

104. The device of any one of claims 62-103, wherein the device is designed for multiple uses.

105. The device of any one of claims 62-104, wherein the device is modular, wherein the first chamber and the second chamber are designed for multiple uses, and wherein the first and second chamber tip bulbs and the first and second slidable arms are designed for single use.

106. The device of claim 105, wherein the first chamber and the second chamber comprise a metal, and wherein the first and second chamber tip bulbs and the first and second slidable arms comprise a plastic or a resin.

107. The device of any one of claims 62-106, wherein regions of the device that contact the patient's face have rounded edges.

108. The device of any one of claims 62-107, further comprising a first slot at the top of the first chamber and a second slot at the top of the second chamber, each slot having a tapered thickness, wherein modular attachments can be inserted into the first slot and the second slot.

109. The device of claim 108, further comprising a modular level, wherein the modular level can be inserted into the first slot or the second slot.

110. The device of any one of claims 62-109, wherein the first and second slidable arms each further comprise a hole to allow a first reference dot to be marked on the face of the patient, and wherein the first and second chambers each further comprise a hook to allow a second reference dot to be marked on the face of the patient.

11 1. A method of using the device of any one of claims 62-110 for measuring exophthalmos or enophthalmos, the method comprising: positioning the device of any one of claims 58-102 on the face of the patient such that the first eye rest element is over the first eye and the second eye rest element is over the second eye; lowering the first slidable arm until the first eye rest element rests on the first eye of the patient; lowering the second slidable arm until the second eye rest element rests on the second eye of the patient; measuring exophthalmos or enophthalmos of the first eye using the first measuring element; and measuring exophthalmos or enophthalmos of the second eye using the second measuring element.

112. The method of claim 111 , wherein the patient has thyroid eye disease, orbital cellulitis, dacryoadenitis, Erdheim-Chester disease, mucormycosis, an orbital pseudotumor, high-altitude cerebral edema, granulomatosis with polyangiitis, nasopharyngeal angiofibroma, Hand-Schuller- Christian disease, capillary hemangioma, cavernous hemangioma, a dermoid cyst, aortic insufficiency, orbital fracture, retrobulbar hemorrhage, carotid-cavernous fistulas, Cushing’s syndrome, craniosynostosis, Crouzon syndrome, Pfeiffer syndrome, pansynostosis, orbital varix, an orbital lymphatic malformation, pseudoenophthalmos, facial asymmetry, contralateral proptosis, microphthalmos, ptosis, cranialstenosis, granulomatosis with polyangiitis (Wegener’s granulomatosis), idiopathic orbital inflammation, tuberculosis, orbital myositis, atypical mycobacterial infection, a vascular anomaly, exposure to pressure, an iatrogenic injury, radiotherapy, cavernous sinus thrombosis, an orbital neoplasm, orbital metastasis, metastatic neuroblastoma, scirrhous breast carcinoma, gastric carcinoma, lung carcinoma, rhabdomyosarcoma, an epithelial cyst, glioma of the optic nerve, meningioma, orbital extension of retinoblastoma, orbital lymphoma, leukemia, mucocele, lacrimal gland tumor, structural abnormality, paranasal sinus mucoceles, maxillary sinus disease, chronic maxillary sinusitis, silent sinus syndrome, maxillary hypoplasia, absence of the greater sphenoid wing, neurofibromatosis, an orbital bony defect, congenital bony orbital asymmetry, congenital fibrosis of the extraocular muscles (CFEOM), Paget’s disease, fat atrophy, senile enophthalmos, lipodystrophy, scleroderma, Parry-Romberg syndrome, blue rubber bleb naevus syndrome, schizophrenia, Leber’s congenital amaurosis, Cockayne’s dystropyhy, hydrocephalus and V-P shunt, restrictive myopathy, Duane’s retraction syndrome, sarcoidosis, primary orbital leiomyoma, posterior traction secondary to fibrosis of the extraocular muscles or connective tissues, trisomy 9p, trisomy 7q, or Horner’s syndrome.

113. The method of claim 1 11 or 1 12, wherein said measuring exophthalmos or enophthalmos of the first eye and the second eye is performed during ocular surgery.

114. The method of claim 113, wherein the ocular surgery comprises orbital fracture repair or orbital decompression.

115. The method of claim 113 or 1 14, wherein exophthalmos or enophthalmos of the first eye and the second eye is measured multiple times during the ocular surgery using the device.

116. The method of any one of claims 113-1 15, further comprising measuring exophthalmos or enophthalmos of the first eye and the second eye with the device before the ocular surgery, after the ocular surgery, or a combination thereof.

117. The method of any one of claims 113-116, further comprising sterilizing the device prior to performing the ocular surgery.

118. The method of any one of claims 111 -117, wherein said measuring exophthalmos or enophthalmos of the first eye comprises measuring distance between the corneal apex and the lateral orbital rim of the first eye, and said measuring exophthalmos or enophthalmos of the second eye comprises measuring distance between the corneal apex and the lateral orbital rim of the second eye.

119. The method of any one of claims 11 1 -118, further comprising measuring difference in the exophthalmos or enophthalmos of the first eye and the second eye.

120. The method of any one of claims 1 11 -119, wherein the patient is in a supine position.

121. A kit comprising the device of any one of claims 62-1 10 and instructions for measuring exophthalmos or enophthalmos with the device.

122. The kit of claim 121 , wherein the device is sterilized and contained in a packaging comprising a sterile compartment for holding the device.