RU2844725C1 - Method of surgical treatment of diabetic macular oedema - Google Patents

Abstract

FIELD: medical science.

SUBSTANCE: invention refers to medicine, namely to ophthalmosurgery, and can be used in surgical management of diabetic macular oedema, DMO. That is ensured by transconjunctival three-port vitrectomy. A segment of an internal limiting membrane ILM is removed from the temporal side in the parafoveolar direction with leaving an intact retinal segment at a distance of one diameter of an optic nerve head ONH from the fovea. A size of the removed fragment makes three diameters of the ONH. Thereafter, one of the ports is removed. Ozurdex implant is inserted through said sclerotomic opening into the vitreal cavity.

EFFECT: invention provides controlled and non-traumatic removal of the ILM fragment with preservation of the intact foveal zone, and also ensures the achievement and preservation of the planned functional result for a long period of time, regardless of the general condition of the patient, in particular fluctuations in the level of sugar in the blood, which increases the effectiveness of the intervention.

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Description

The invention relates to medicine, namely to ophthalmic surgery, and can be used in the surgical treatment of diabetic macular edema (DME).

DME is one of the significant and difficult-to-solve problems of modern ophthalmology, since there is no single classification, and the pathogenesis of edema is complex and multifactorial. Currently, various methods are used to treat DME, such as intravitreal administration of anti-VEGF drugs, steroids, laser coagulation and surgery, including vitrectomy and peeling of the internal limiting membrane (ILM) (Das A., Friberg T.R. Therapy for Ocular Angiogenesis. Principles and Practice. Philadelphia: Lippincott Williams & Wilkins, 2011. 377 p.; Shchuko A.G., Buriy V.V., Novolodsky A.I., Zaitseva N.V. Peeling of the internal limiting membrane in the treatment of diabetic macular edema // Russian Medical Journal, 2012).

During vitreoretinal intervention, the advisability of performing ILM peeling remains debatable. Aggressive ILM peeling over the entire area of the macula, including the fovea zone, can cause additional complications with disruption of the retinal architecture and functions, which reduces the patient's visual acuity (Petrachkov D.V., Balkar S.Sh., Filippov V.M. The role of internal limiting membrane peeling in the surgical treatment of diabetic macular edema (clinical observations) // Russian ophthalmology online. Modern technologies in ophthalmology No. 1 2024. Section 1. Endovitreal surgery, p. 123).

In recent years, a number of techniques have been developed aimed at preserving part of the ILM during surgical treatment of DME.

A method of surgical treatment of patients with macular edema complicated by epiretinal membrane in diabetes mellitus is known (RU patent No. 2687592), which includes circular peeling of the ILM under intraoperative control of optical coherence tomography (OCT), starting from the place with the lowest photosensitivity according to microperimetry data. The disadvantage of this method is the need to remove a fairly large (more than 2 mm in diameter) fragment of the ILM with elements of the papillomacular bundle of retinal fibers.

A method for removing the ILM during surgical treatment of macular edema of various etiologies is known (RU patent No. 2563438), which includes gradual removal of the ILM in small sections in the form of petals and removal of the ILM in an area from 2.0-2.5 mm to 0.5-0.8 mm around the foveola to eliminate horizontal retinal tractions. The method allows preserving the foveolar fragment of the ILM, which eliminates thinning of the retina in the macular region, however, when forming petals, excessive traction traumatic effect on the retina with the tip of the vitreotome and removal of part of the fibers of the papillomacular bundle inevitably occurs.

The closest to the proposed invention is a method for removing the ILM in vitreomacular traction syndrome in patients with proliferative-diabetic retinopathy (patent RU No. 2810243), which provides for the separation of ILM sections around the fovea with the formation of a retinal zone without ILM in the form of a horseshoe-shaped figure located between the vascular arcades. Separation is performed with vitreous tweezers in fragments in the direction from one end of the horseshoe-shaped figure to the other. In the event of a tear in the fragment being removed during separation, the adjacent edge of the ILM is captured with tweezers and the membrane is removed in the same direction until the horseshoe shape is achieved while preserving a section of the ILM in the center of the fovea and in the area of the papillomacular bundle located between the ends of the horseshoe-shaped figure. The retinal zone without ILM is located with an indentation inward from the vascular arcades at a distance of at least 0.5 optic nerve head (ONH) diameter, and the distance between the ends of the horseshoe figure is 1-1.5 ONH diameters. The method allows to obtain high visual acuity in the postoperative period with a decrease in surgical and postoperative complications due to local removal of ILM in the form of a horseshoe-shaped flap without peeling of the papillo-macular bundle and fovea zone. The disadvantages include the technical complexity of the method in the process of forming a horseshoe-shaped flap at different distances from the fovea zone, requiring the need to remove ILM in separate areas with their interceptions, which increases the trauma of the method due to the risks of retinal injury, tears in the removed fragments and damage to the fovea zone. In addition, the treatment result does not last long, since with jumps in blood sugar levels, a sharp deterioration in the condition of the retina is possible.

The use of steroid therapy for the treatment of DME is known, in particular, the intravitreal administration of the biodegradable implant Ozurdex, the active substance of which is the glucocorticosteroid dexamethasone in an amount of 0.7 mg (Boyer D.S., Yoon Y.H., Belfort Jr.R. et al. Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema // Ophthalmology. - 2014. - Vol. 121. - N. 10. - P. 1904 - 1914). Dexamethasone has a pronounced anti-inflammatory effect and reduces the formation of edema by reducing fibrin deposition, capillary permeability and phagocytic infiltration in response to inflammation, inhibits connective tissue reactions during the inflammatory process and reduces the possibility of proliferation. After intravitreal administration, the Ozurdex implant provides gradual release of dexamethasone over six months, eliminating the need for monthly injections. According to the literature, the maximum therapeutic effect of the drug is observed in most cases on the 60th day and persists for another 30 days (Pacella E, Vestri AR, Muscella R. Preliminary results of an intravitreal dexamethasone implant (Ozurdex) in patients with persistent diabetic macular edema. Clin Ophthalmol. 2013;7: 1423-1428. doi:10.2147/OPTH.S48364).

However, it was not possible to find any sources of information in the literature describing the simultaneous performance of vitreoretinal intervention with the introduction of the Ozurdex implant and evaluating the results of such treatment.

The proposed invention is aimed at developing a new atraumatic method for treating DME while preserving the foveolar ILM and maintaining treatment results for a long period of time.

The essence of the method is that during the surgical treatment of DME, the ILM section is removed from the temporal side parafoveolarly, leaving intact a section of the retina at a distance of one optic nerve head diameter from the fovea zone. The size of the removed fragment is three optic nerve head diameters. After that, one of the ports is removed, a syringe pen is inserted through the resulting sclerotomy hole, and the Ozurdex implant is inserted into the vitreous cavity.

The technical result achieved by implementing the invention consists in a more controlled and atraumatic performance of the removal of a fragment of the ILM with preservation of the intact fovea zone, as well as the possibility of achieving and maintaining the planned functional result for a long period of time, regardless of the general condition of the patient, in particular, fluctuations in blood sugar levels, which increases the effectiveness of the intervention.

Formation of rhexis from the temporal side allows to preserve the fovea zone and the papillomacular bundle zone intact, and to restore a constant flow of fluid through the pigment epithelium for the outflow of intraretinal fluid, which contributes to the formation of edema, and the introduction of the Ozurdex implant ensures the preservation of the functional result of treatment (edema stabilization) for a long period of time.

The method of surgical treatment of DME with preservation of the foveolar part of the ILM is carried out as follows. Standard treatment of the surgical field is performed, after which transconjunctival three-port vitrectomy is performed according to the standard technique using Kenalog dye for detailing the posterior cortical layers of the vitreous body and ILM. The posterior hyaloid membrane is removed. Next, an area without ILM is formed on the temporal side parafoelarly using end-grasping vitreous tweezers, leaving an intact area of the retina at a distance of one optic disc diameter from the foveola. The size of the removed fragment is three optic disc diameters. Then one of the ports is removed, a syringe pen is inserted through this sclerotomy hole and an Ozurdex implant is inserted into the vitreous cavity. The operation is completed by washing the conjunctival cavity with a 2% iodine solution and applying an aseptic monocular dressing.

The invention is illustrated by the following clinical examples.

Example 1. Patient T., born in 1966.

History of diabetes mellitus for about 15 years, tablet therapy. Endovitreal intervention with phacoemulsification (PEC) and intraocular lens (IOL) implantation was performed in 2022 for hemophthalmos.

Diagnosis upon admission: OS - DME, pseudophakia, avitria, diabetic retinopathy.

Vis OS=0.2; IOP=13 mmHg.

Objectively OS: the cornea is transparent, the anterior chamber is average.

The pupil is round, the reaction to light is good. The position of the IOL is correct. Avitria. The fundus of the eye: the optic disc is pale pink, the borders are clear. In the macular area - cystic edema, hard exudates, tortuosity of the vessels. The retina is treated with laser coagulation to the middle periphery. OCT: in the foveolar zone - cystic edema of the neuroepithelium, hard exudates (see Fig. 1).

The patient underwent a combined vitreoretinal intervention using 25g surgery and 3 ports using standard technology in accordance with the proposed invention.

The ILM was peeled paramacularly using vitreoretinal tweezers. After the surgical treatment, an implant of the drug "Ozurdex" was introduced into the vitreous cavity through one of the sclerostomas. No intraoperative hemorrhagic complications were observed.

During the ophthalmological examination on the 7th day after the operation, according to OCT data, the edema had resorbed, and the postoperative period proceeded without complications.

Vis OS=0.6 with correction, IOP=15.5 mmHg.

Objectively OS: the cornea is transparent, the anterior chamber is average.

The pupil is round, the reaction to light is good. The IOL is in the correct position. Avitria. The fundus: the optic disc is pale pink, the borders are clear. In the macular area - the reflex is reduced, there are hard exudates, the vessels are tortuous. The retina is treated with laser coagulation to the middle periphery. OCT: the retinal profile is correct, there is no macular edema, there are hard exudates.

At examination after 1 month Vis OS=0.8 with correction

At the examination after 6 months Vis OS=0.8. The OS condition after the operation, shown in Fig. 2, confirms the effectiveness of the invention.

Example 2. Patient V., born in 1956. History of diabetes mellitus for about 10 years, tablet therapy. Endovitreal intervention was performed in 2020 for hemophthalmos.

Diagnosis on admission: OD - DME, initial complicated cataract, avitria, diabetic retinopathy.

Vis OD=0.1; IOP=13 mmHg.

Objectively OD: cornea is transparent, anterior chamber is average.

The pupil is round, the reaction to light is good. Cortical opacities in the lens. Avitria. Fundus: the optic disc is pale pink, the borders are clear. In the macular area - cystic edema, isolated hemorrhages, tortuosity of vessels. The retina is treated with laser coagulation to the middle periphery.

OCT: in the foveolar zone - cystic edema of the neuroepithelium.

The patient underwent combined vitreoretinal intervention in accordance with the proposed invention: endovitreal intervention using 25g surgery and 3 ports using standard technology. ILM peeling was performed paramacularly using vitreoretinal tweezers. After the surgical treatment, an implant of the drug "Ozurdex" was inserted into the vitreous cavity through one of the sclerostomas.

No intraoperative hemorrhagic complications were observed.

During ophthalmological examination on the 7th day after surgery

Vis OD - 0.8 with correction, IOP=15.5 mmHg.

Objectively OD: cornea is transparent, anterior chamber is average.

The pupil is round, the reaction to light is good. Cortical opacities in the lens. Avitria. Fundus: the optic disc is pale pink, the borders are clear. In the macular area - the reflex is reduced, isolated hemorrhages, tortuosity of the vessels. The retina is treated with laser coagulation to the middle periphery.

OCT: retinal profile is correct, macular edema is absent.

Upon examination after 1 month Vis OD=0.8 with correction

Upon examination after 6 months, Vis OD=0.8 with correction.

Claims (1)

A method for surgical treatment of diabetic macular edema, including performing a three-port vitrectomy and removing a section of the internal limiting membrane (ILM) around the fovea, characterized in that the ILM is removed from the temporal side parafoveolarly, leaving intact a section of the retina at a distance of one optic nerve disc (OND) diameter from the fovea zone, the size of the fragment to be removed is three OND diameters, after which one of the ports is removed, and an Ozurdex implant is inserted into the vitreous cavity through this sclerotomy opening.