RU2735465C1 - Method of treating macular retina fractures without vitreal cavity tamponage - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to ophthalmology, and can be used for surgical treatment of eye diseases. Treating large macular ruptures of the retina without tamponade of the vitreal cavity. That is followed by vitrectomy 25G, staining and internal limiting membrane (ILM) peeling. It is applied on a region of rupture of blood plasma enriched with thrombocytes (PRP). PRP application with its subsequent six-minute exposure is performed under a perfluorodecalin bubble. Vitreous body is removed in the direction from the anterior parts to the optic nerve head (ONH). Posterior layers of the vitreous body are stained with a vital dye and separated from the retinal surface by aspiration technique, starting from ONH, lifting them to the periphery. ILM staining is followed by mobilization thereof. Circular membrane membranorexis is made around the foveola with size of 2 ONH diameters. ILM is separated from periphery to center by separate sections along meridians, collecting it above rupture and removing with tweezers. Subsequent approach of macular rupture edges is performed by extrusion cannula in medium of perfluorodecalin by passive aspiration, within ILM peeling zone with the help of distal end of cannula installed above fracture zone. Prepared PRP volume 0.1 ml is applied with six-minute exposition of perfluorodecalin under the bladder. It is followed by removal of perfluorodecalin by passive aspiration, after removal of ports sclerostoma is closed, operation is completed without tamponade of vitreal cavity.

EFFECT: method enables improving visual acuity on the first postoperative day, eliminating the patient's forced position face down, reducing the risk of developing cataract and increasing postoperative IOP, possibility of lifting to high altitude and air flights in early postoperative period.

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Description

The invention relates to medicine, namely to ophthalmology, and can be used for the surgical treatment of eye diseases.

Macular rupture (MR) is one of the most common pathologies of the vitreomacular interface, leading to a decrease in visual acuity and the appearance of metamorphopsia. According to studies, the incidence of this pathology among people over 55 years of age ranges from 1% to 3% (Bayborodov Y.V., Balashevich L.I. Microincisional surgical treatment of the first stage of macular rupture without vitrectomy under intraoperative OCT control. Ophthalmosurgery. 2017. No. 1. S. 53-58).

State of the art

In 1991, Kelly N.E. and Wendell R.T., demonstrated the efficacy of treating macular ruptures by performing vitrectomy with removal of the posterior hyaloid membrane (PCM), internal bordering membrane (IPM) peeling and gas tamponade, followed by the mandatory position of the patient "face down". This surgical technique to this day remains the "gold standard" for the treatment of macular tears less than 400 microns and allows you to obtain anatomical results in 97% of cases [Kelly N. E., Wendel R. T. Vitreous surgery for idiopathic macular holes: results of a pilot study // Archives of ophthalmology. - 1991. - T. 109. - No. 5. - S. 654-659.].

Anatomical closure of tears larger than 400 microns is achieved in 69 - 94.4% [Jaycock P. D. et al. Outcomes of macular hole surgery: implications for surgical management and clinical governance // Eye. - 2005. - T. 19. - No. 8. - S. 879-884, Scott R. A. H. et al. Visual and anatomical results of surgery for long standing macular holes // British journal of ophthalmology. - 2000. - T. 84. - No. 2. - P. 150-153] cases, however, a good anatomical result does not always allow achieving high visual functions. According to literature data, in 74% of cases, visual acuity in this category of patients remains at the level of 0.1-0.2 [Andrew N. et al. Modification of the inverted internal limiting membrane flap technique for the treatment of chronic and large macular holes // Retina. - 2016. - T. 36. - No. 4. - S. 834-837.]. Known surgical techniques, during which they carry out mechanical convergence of the edges, the formation of an inverted flap of the VPM, tamponade with silicone oil, laxative retinotomy [Alpatov SA, Shchuko AG, Malyshev V.V. Pathogenesis and treatment of idiopathic macular ruptures. - Novosibirsk: Nauka, 2005 .-- 192 p., Balashevich L.I., Baiborodov Ya.V., Zhogolev K.S. Surgical treatment of vitreomacular interface pathology. Literature review in questions and answers // Ophthalmosurgery. - 2015. - No. 2. - S. 80-85]. However, this surgery is associated with mechanical trauma to the retina, the formation of an inadequate foveolar profile, in some cases requires additional surgical intervention, as well as the forced position of the patient in the postoperative period.

A promising direction in the treatment of MR is the use of autologous platelet-rich blood plasma (PRP or autologous plasma concentrate, Platelet Rich Plasma - PRP) [Duker J. S. et al. International classification of Vitreomacular adhesion, traction and macular opening in the Vitreomacular traction study group / / Ophthalmology. - 2013. - T. 120. - No. 12. - S. 2611-2619., Gass J.D. Reappraisal of biomicroscopic classification of stages of development of a macular hole // American Journal of Ophthalmology. - 1995. - Vol. 119-# 6. - P.752-759, Jaycock P. D. et al. Outcomes of macular hole surgery: implications for surgical management and clinical governance // Eye. - 2005. - T. 19. - No. 8. - S. 879-884.]. At present, surgical treatment of macular ruptures using PRPs is completed in all cases with gas-air tamponade and forced positioning of the patient “face down” in the early postoperative period. (Krupina E.A. Surgical treatment of idiopathic macular rupture with the use of platelet-rich blood plasma, Dissertation for the degree of candidate of medical sciences, M., 2019).

At the same time, the use of PRP can provide a good result even without the patient's "face down" position and the pressure of the gas bubble on the edges of the rupture [Kapoor K.G., Khan A.N., Tieu B.C., Khurshid G.S. Revisiting autologous platelets as an adjuvant in macular hole repair: chronic macular holes without prone positioning // Ophthalmic Surg. Lasers Imaging. - 2012. -Vol. 43 - No. 4. -R. 291-295, Gaudric A. et al. Autologous platelet concentrate for the treatment of full-thickness macular holes // Graefe's archive for clinical and experimental ophthalmology. - 1995. - T. 233. - No. 9. - S. 549-554].

The closest analogue is (RU 2698633, 08/28/2019) a method of surgical treatment of macular retinal ruptures, for which a 3-port 25-27G vitrectomy of the valve type is performed with the isolation and removal of the posterior hyaloid membrane, staining and removal of the internal boundary membrane (IPM), replacement balanced saline solution (BSS) in air and applying a drop of platelet-rich blood plasma to the rupture area. Before staining the VPM, a drop of a perfluoroorganic compound (PFOS) is applied to the macular rupture, which, after staining, is aspirated, and after the complete replacement of BSS with air and a drop of platelet-rich blood plasma is applied to the area of the rupture, wait 1 minute to form a fibrin film. Then a drop of PFOS is applied to the fibrin film, wait 5 minutes, then the drop of PFOS is removed by passive aspiration and the air is replaced with BSS.

The known method, although it allows you to eliminate the macular rupture, is technically difficult to implement due to a large number of intravitreal manipulations. It should also be noted that performing operations on the macular area in the air is associated with poor visual control and increases the risk of trauma. It is important to remember that the formation of a stable platelet-fibrin film takes six to eight minutes. Thus, due to its high specific gravity, perfluorodecalin, although it contributes to a more dense pressing of the fibrin film to the retina, but placed on the still unformed fibrin structure, can cause its displacement along with the fixed retina, thereby leading to its deformation and trauma.

In addition, there is a known method (Meena Chakrabarti et al. Closing macular holes with "macular plug" without gas tamponade and postoperative posturing, Retina. 2017 Mar; 37 (3): 451-459), which is characterized by 23G vitrectomy, wide peeling VPM with the formation of an inverted flap, which, together with autologous preserved blood, fills the macular gap, as well as the completion of the operation without tamponade of the vitreous cavity. However, despite the stable closure of the macular gap in the long-term postoperative period, it should be noted that this technique has a number of disadvantages. In our opinion, it is difficult to calculate the required amount of VPM to fill the MR. At the same time, the refusal to match the edges of the macular rupture and a large amount of VPM tissue can provoke excessively intense gliosis and incorrect orientation of the restoration of retinal histoarchitectonics.

The technical problem to be solved was the implementation of sparing treatment of large macular ruptures, which allows to achieve high and stable functional results, to minimize the risk of macular rupture recurrence in the postoperative period.

Disclosure of the essence of the invention

The achieved technical result is the complete closure of the macular gap with a minimum defect in the ellipsoidal zone of photoreceptors and a minimum size of the repair zone.

In our opinion, in the absence of tamponade of the vitreous cavity, the mobility of the edges of the macular rupture is preserved, which with subsequent retraction of the platelet-fibrin plug contributes to their complete closure and the formation of the correct foveolar profile of the central retinal zone already in the early postoperative period without a pronounced repair zone.

The developed method of surgical treatment of macular rupture without the use of postoperative tamponade of the vitreous cavity with gas or any other substitute for the vitreous body can be used in everyday medical practice.

The advantages of the proposed method include:

- improving visual acuity already on the first day after surgery;

- the possibility of instrumental OCT control of the closure of the macular rupture already on the first day after the operation;

- the absence of a forced position of the patient face down, which is difficult for many general somatic diseases and hypersthenic constitution of the patient;

- the risk of cataract development and IOP increase in the postoperative period decreases;

- there is still a possibility of ascent and air flights in the early postoperative period.

The listed aspects of the technical result are ensured by the following set of essential features:

- perform vitrectomy 25G, carry out staining and peeling of the internal boundary membrane (IPM), apply platelet-rich blood plasma (PRP) to the rupture area,

- application of PRP with its subsequent six-minute exposure is carried out under the bubble of perfluorodecalin,

- removal of the vitreous body is carried out in the direction from the anterior sections to the optic nerve head (optic nerve disc),

- the posterior layers of the vitreous body are stained with a vital dye and separated from the surface of the retina using an aspiration technique, starting from the optic disc, lifting them to the periphery,

- after staining the VPM, it is mobilized, circular membranorexis is carried out around the foveola of 2 diameters of the optic disc,

- The VPM is separated from the periphery to the center in separate sections along the meridians, collecting it over the gap and removing it with tweezers,

- the subsequent convergence of the edges of the macular rupture is carried out with an extrusion cannula in a perfluorodecalin medium by the method of passive aspiration,

- within the VPM peeling zone, using the distal end of the cannula, installed above the rupture zone, apply the prepared PRP with a volume of 0.1 ml, with a six-minute exposure under the perfluorodecalin bubble,

- carry out the removal of perfluorodecalin by means of passive aspiration,

- after removal of the ports, the sclerostomy is sutured,

- the operation is completed without tamponade of the vitreous cavity.

Implementation of the invention

1. The technology of obtaining autologous platelet-rich blood plasma by one-stage closed centrifugation is an affordable and easily reproducible procedure with standard laboratory equipment, which expands the possibilities of its application. The technique (for example, described in RU 2713772 02/07/2020) can be carried out as follows:

To obtain PRP, 12.5-13.5 ml of blood was drawn into a syringe with an anticoagulant (sodium citrate + Dextrose) - 1.5 ml, blood was transferred into a test tube (YCELLBIO-KIT, Korea) and centrifugation (centrifuge "Armed" 80- 2s, Russia) for 5 minutes at 4000 rpm.

Blood was taken from the cubital vein 30 minutes before the operation, before premedication. Blood was filled in a 20 ml syringe with a pre-selected anticoagulant, taking into account the patient's sex (12.5 ml of blood and 1.5 ml of anticoagulant for men or 13.5 ml of blood and 1.5 ml of anticoagulant for women). Then the syringe was closed and the contents were mixed by inverting or rotating 6-8 times (without shaking).

Then a certain volume of blood (12.5-13.5 ml) was injected into the side opening of the tube lid at an angle of 45 ° with an 18 G needle. The time between taking a blood sample from a vein and centrifugation was no more than 10 minutes. Centrifugation was carried out on an Armed 80-2s, Russia centrifuge at room temperature (from +18 to +24 ° C). The range of rotation speed of the device is from 1000 to 4000 rpm with a step of 500 rpm.

A timer with centrifugation time setting was used to control the work. The blood tube was placed in a centrifuge. The same test tube, filled with water, was placed in the opposite cell as a counterweight to balance the samples.

By a single centrifugation, separation of blood into erythrocyte mass and plasma took place in such a way that platelet-rich plasma was collected in a narrow part of the tube. Subsequently, the PRP was removed through the central opening of the tube with a blunt-pointed thin-walled 27G cannula.

2. The stage of surgical treatment of MR is represented by a modified surgical technique.

All vitreoretinal interventions can be performed using the Constellation device (Alcon, USA). Optimal is the performance of a 25G microinvasive three-port vitrectomy.

Removal of the vitreous body is carried out in the direction from the anterior sections to the optic nerve head (optic nerve disc). The posterior layers of the vitreous are stained with a vital dye and separated from the surface of the retina using an aspiration technique, starting from the optic disc, gradually raising them to the periphery. Staining of the internal boundary membrane (IPM) is carried out for its better visualization using an intravitreal dye. Then VPM is mobilized with disposable endovitreal forceps, circular membranorexis is carried out around the foveola 2 diameters of the optic nerve disc, within the upper and lower temporal arcades. The VPM is separated from the periphery to the center in separate sections along the meridians, collecting it over the gap and removed with tweezers.

The subsequent convergence of the edges of the macular rupture is carried out with an extrusion cannula with a silicone tip in a perfluoroorganic compound (PFOS) - perfluorodecalin by the method of passive aspiration. Then, within the VPM peeling zone, the prepared autologous PRP with a volume of 0.1 ml is applied. In this case, the distal end of the cannula is placed over the rupture zone.

Subsequently, a six-minute exposure was carried out under the PFOS bubble. Then carry out the removal of perfluorodecalin by means of passive aspiration. After removal of the ports, the sclerostomy is sutured. The operation is completed with normotonia, without tamponade of the vitreous cavity.

The study presents the results of treatment of 12 patients (12 eyes) with idiopathic perforating macular tears. Patients were recruited using a continuous sample method. The gender ratio of patients: 9 women (75%) aged 53 to 75 years and 3 men (25%) - from 55-71 years. The average age of the subjects was 62.75 ± 6.04 years. Patients complained of low vision, distortion of objects and difficulty working at close range.

All patients underwent a comprehensive examination (visometry, tonometry, biomicroscopy) before surgery and in the postoperative period, and the morphometric parameters of the macular zone were assessed using optical coherence tomography (OCT). The maximum corrected visual acuity at the time of admission averaged 0.11 ± 0.04. All subjects had a large through MR (> 600 μm). The size of the break varied from 633 to 932 μm (770.67 ± 95.83). It should be noted that 7 patients had a concomitant diagnosis of initial age-related cataract, the remaining 5 eyes were pseudophakic. Patients with signs of cataract underwent targeted biomicroscopy of the lens in a state of drug mydriasis.

In all cases, the same type of opacity in the cortical layers of the lens was revealed. However, despite the presence of initial signs of cataract in this group of patients, the degree of opacity could not significantly affect visual acuity and, accordingly, did not complicate the visualization of the fundus when planning surgical treatment.

Patient J., 64 years old

I went to the clinic with complaints of a sharp decrease in vision in the left eye and the appearance of a dark spot in the field of vision.

According to objective examination, the maximum corrected visual acuity (MCVA) was OS - 0.1.

Status oculorum: OS of the eye is calm, the cornea is transparent, pseudophakia. On the fundus of the optic nerve disc is pale pink, the course and caliber of the vessels are not changed, a pink rounded reflex is determined in the macular zone, on the periphery without gross focal pathology.

Additional examination: according to OCT scan data, a through macular rupture is visualized, the edges of the rupture are thickened, cystic changes. Hypoechoic cavities are located in the inner and outer nuclear layers. The outer boundary membrane, the junction zone of the inner and outer segments of photoreceptors outside the rupture are not changed. The edematous edges of the rupture are somewhat raised. The size of the macular break is 659 μm. The defect of the ellipsoid zone is 1660 microns.

A microinvasive three-port vitrectomy 25G, contrasting and removal of the posterior hyaloid membrane (PMM), staining and peeling of the internal boundary membrane (IPM) were performed routinely. Subsequent convergence of the edges of the macular rupture was carried out by an extrusion cannula with a silicone tip in a perfluoroorganic compound (PFOS) medium - perfluorodecalin by passive aspiration. Then, within the VPM peeling zone, PRP was applied, followed by a six-minute exposure under the PFOS bubble. Then carried out the removal of perfluorodecalin. After removal of the ports, the sclerotomes were sutured. Tamponade of the vitreous cavity was not performed.

The examination was carried out on days 1, 10, 30 and 90 after treatment. According to the observation results, the BCVA after treatment was 0.08, 0.3, 0.3 and 0.6, respectively.

Patient I., 70 years old

I went to the clinic with complaints of a sharp decrease in the vision of the right eye.

According to objective examination, the maximum corrected visual acuity (MCVA) was OD - 0.08.

Status oculorum: the eye is calm, the cornea is transparent, opacity in the cortical layers of the lens. On the fundus of the optic nerve disc is pale pink, the course and caliber of the vessels is not changed, a pink rounded reflex is determined in the macular zone, single drusen, on the periphery without gross focal pathology.

Additional examination: according to OCT scan data, a through macular rupture is visualized, the edges of the rupture are thickened, cystic changes. Hypoechoic cavities are located in the inner and outer nuclear layers. The outer boundary membrane, the zone of articulation of the inner and outer segments of photoreceptors outside the gap are not changed. The edematous edges of the rupture are somewhat raised. Outside the gap, a wave-like change in the retinal pigment epithelium (RPE) is visualized. The size of the macular gap is 882 μm. The defect of the ellipsoid zone is 1499 microns.

A microinvasive three-port vitrectomy 25G, contrasting and removal of the posterior hyaloid membrane (PMM), staining and peeling of the internal boundary membrane (IPM) were performed routinely. Subsequent convergence of the edges of the macular rupture was carried out by an extrusion cannula with a silicone tip in a perfluoroorganic compound (PFOS) medium - perfluorodecalin by passive aspiration. Then, within the VPM peeling zone, PRP was applied, followed by a six-minute exposure under the PFOS bubble. Then carried out the removal of perfluorodecalin. After removal of the ports, the sclerotomes were sutured. Tamponade of the vitreous cavity was not performed.

The examination was carried out on days 1, 10, 30 and 90 after treatment. According to the observation results, the BCVA after treatment was 0.04, 0.2, 0.3 and 0.5, respectively.

Patient J., 60 years old

I went to the clinic with complaints of a sharp decrease in vision in the left eye and the appearance of a dark spot in the field of vision.

According to the objective examination, the maximum corrected visual acuity (MCVA) was OS - 0.15.

Status oculorum: OS of the eye is calm, the cornea is transparent, pseudophakia. On the fundus of the optic nerve disc is pale pink, the course and caliber of the vessels are not changed, a pink rounded reflex is determined in the macular zone, on the periphery without gross focal pathology.

Additional examination: according to OCT scan data, a through macular rupture is visualized, the edges of the rupture are thickened, cystic changes. Hypoechoic cavities are located in the inner and nuclear layers. The outer boundary membrane, the junction zone of the inner and outer segments of photoreceptors outside the rupture are not changed. The edematous edges of the rupture are somewhat raised. The size of the macular rupture is 718 microns. The defect of the ellipsoid zone is 1332 microns.

A microinvasive three-port vitrectomy 25G, contrasting and removal of the posterior hyaloid membrane (PMM), staining and peeling of the internal boundary membrane (IPM) were performed routinely. Subsequent convergence of the edges of the macular rupture was carried out by an extrusion cannula with a silicone tip in a perfluoroorganic compound (PFOS) medium - perfluorodecalin by passive aspiration. Then, within the VPM peeling zone, PRP was applied, followed by a six-minute exposure under the PFOS bubble. Then carried out the removal of perfluorodecalin. After removal of the ports, the sclerotomes were sutured. Tamponade of the vitreous cavity was not performed.

The examination was carried out on days 1, 10, 30 and 90 after treatment. According to the observation results, the BCVA after treatment was 0.15, 0.4, 0.5 and 0.7, respectively.

In all patients, according to the OCT scan the next day after the operation, hypoechoic tissue was visualized, filling the gap and spreading to the surface of the retina. On days 10, 30 and 90, a consistent significant decrease in the hypoechoic area and defect in the ellipsoid zone was determined.

Claims (1)

A method of treating large macular retinal tears without tamponade of the vitreous cavity, including performing a 25G vitrectomy, staining and peeling the internal border membrane (IPM), applying platelet-rich blood plasma (PRP) to the area of the rupture, characterized in that the application of PRP followed by a six-minute exposure is carried out under the bubble of perfluorodecalin, removal of the vitreous body is carried out in the direction from the anterior sections to the optic nerve head (optic nerve disc), the posterior layers of the vitreous body are stained with a vital dye and separated from the surface of the retina using aspiration technique, starting from the optic disc, raising them to the periphery, after staining the VPM mobilize it, carry out a circular membranorexis around the foveola 2 diameters of the optic disc, the VPM is separated from the periphery to the center by separate sections along the meridians, collecting it over the gap and removing it with tweezers, the subsequent convergence of the edges of the macular rupture is carried out by an extrusion canal Julia in perfluorodecalin medium by the method of passive aspiration, within the peeling zone of the VPM, using the distal end of the cannula installed above the rupture zone, the prepared PRP with a volume of 0.1 ml is applied, with a six-minute exposure under the perfluorodecalin bubble, perfluorodecalin is removed by passive aspiration, after removal sclerostomy ports are sutured, the operation is completed without tamponade of the vitreous cavity.