RU2812773C1 - Method of treatment of refractory glaucoma - Google Patents

Abstract

FILED: ophthalmology.

SUBSTANCE: invention can be used to treat refractory glaucoma. After standard treatment of the surgical field with a blade, corneal paracentesis is performed at 9 o’clock position. A paralimbal incision of the conjunctiva and Tenon's membrane 4 mm long is formed. Episcleral vessels are coagulated. A superficial scleral flap (SSF) of size 3 is formed× 3 mm, base to limbus, one third of the thickness of the sclera. In the anterior chamber of the PC, 0.2–0.3 ml of viscoelastic is injected through paracentesis. Under the SSF, retreating 0.5 mm from the limbus, in the center of the intrascleral cavity under the cut flap, a hole in the FC is created with a 27G needle. Using an injector, a mini-shunt model P-50 is implanted into this hole. The SSF is fixed on the sides with two interrupted sutures. 0.2 ml of Healaflow gel drainage implant is injected above the SSF. A continuous suture is placed on the conjunctiva. 0.2 ml of viscoelastic is injected into the FC through paracentesis. Having retreated 4–5 mm from the operation area towards the upper fornix, 0.3 ml of Healaflow is injected subconjunctivally.

EFFECT: invention makes it possible to form a stable pathway for the outflow of intraocular fluid, ensuring stable compensation of ophthalmotonus and preservation of visual functions.

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Description

The invention relates to medicine, namely to ophthalmology, and can be used for the treatment of refractory glaucoma.

Refractory glaucoma (RG) combines a variety of clinical forms of glaucoma, characterized by increased fibroplastic activity, leading to obliteration of the outflow tracts of intraocular fluid (IOH) created during standard fistulizing operations (Bettin P., Di Matteo F. Glaucoma: present challenges and future trends. Ophthalmic Res 2013;50(4):197-208. DOI: 10.1159/000348736).

Today, for the treatment of patients with RG, various drainage devices are increasingly used to provide a relatively controlled level of intraocular pressure (IOP) after surgery by creating an additional path for the outflow of IOP from the anterior chamber (AC) (Harsh Kumar, Mithun Thulasidas Pars plana implantation of glaucoma drainage devices - The way to succeed in refractory glaucoma. Indian Journal Ophthalmol 2021 Jul;69(7):1650-1651. doi: 10.4103/ijo.IJO_688_21). One such device is the Express mini-shunt (MS), implanted under the superficial scleral flap (SFL). At the proximal end of the MS there is a spur for local fixation, at the distal end there is a cap to prevent dislocation of the device (Marco N., Chiara P., Francesco N., Michele F. Mini Drainage Devices for Anterior and Intermediate Filtration. Dev Ophthalmol 2017; 59:90 -99.doi:10.1159/000458489).

There is a known method (RF Application No. 2013126762), in which at the beginning of the operation, 0.1-0.2 ml of mitomycin C solution was applied to the sclera in the projection of the PSL on a tuppher, using 0.0005-0.001 mg of dry matter, the PSL was cut out in size 3×3 mm by 1/3 of the thickness of the sclera, perforation of the sclera was performed with an injection needle with a diameter of 30G at an angle of 3-500 from the surface of the iris, an MS was implanted and a scleral groove was additionally cut out to cover the entire volume of the intrascleral cavity.

The method has significant disadvantages. Intraoperative use of mitomycin C leads to long-term maladaptation of the edges of the postoperative wound, and cutting out an additional scleral groove leads to excessive trauma to the intrascleral cavity.

The closest analogue is the method (RF Patent No. 2 531 133), where the authors formed an L-shaped conjunctival incision, the incision began normal to the limbus, 1 mm long, then extended along the limbus 3-4 mm long, the surgical area under the conjunctiva was cleared by temporary movement of the conjunctiva. After separating the conjunctiva and Tenon's membrane, a PSL was sequentially formed with the base to the limbus measuring 4x4 mm, 1/2 the thickness of the sclera, extending 0.5-1.0 mm into the zone of the corneal limbus. Under the PSL in the zone of transition of the cornea to the sclera, in the center of the cut flap, a 27G needle was inserted, through which 0.2-0.3 ml of viscoelastic (Provisk) was injected into the PC, and then the MS Model P 50 (Alcon, USA) was installed there ) using an injector. Then, a hydrogel drainage was implanted parallel to the limbus, distal to the MS, 3 mm from the limbus onto the scleral bed. After reposition, the PSL was fixed with one interrupted suture in the center, while simultaneously fastening and fixing the hydrogel drainage; the free edges of the drainage were straightened between two additional sutures on the sides of the PSL. On the first day after surgery, 5-fluorouracil was injected at a dosage of 0.2-0.3 ml (20-30 mg/ml), subconjunctivally into the filtration cushion. In the postoperative period, 5-fluorouracil was additionally administered once a week, 5-7 times.

The method is not without its drawbacks. Injections of 5-fluorouracil lead to the formation of a cystic filtration cushion of an excessively large volume, and suturing hydrogel drainage often blocks the outflow of intraocular fluid in the surgical area, which leads to relapse of ocular hypertension.

The objective of the invention is to develop an effective and safe method for treating refractory glaucoma.

The technical result of the invention is the formation of a stable outflow path of the intraocular fluid, providing stable compensation of ophthalmotonus and preservation of visual functions.

The method is carried out as follows. After standard treatment of the surgical field with a blade, corneal paracentesis is performed for 9 hours. A paralimbal incision of the conjunctiva and Tenon's membrane 4 mm long is formed, and the episcleral vessels are coagulated. A PSL measuring 3×3 mm is formed, with the base towards the limbus, one-third of the thickness of the sclera, and 0.2-0.3 ml of viscoelastic is injected into the PC through paracentesis. Under the PSL, retreating 0.5 mm from the limbus, in the center of the intrascleral cavity under the cut flap, a hole is formed in the PC using a 27G needle, then using an injector, a model R-50 MS is implanted into this hole. The PSL is fixed on the sides with two interrupted sutures, 0.2 ml of Healaflow gel-like drainage implant is inserted over the PSL, and a continuous suture is placed on the conjunctiva. 0.2 ml of viscoelastic is injected into the PC through paracentesis. Having retreated 4-5 mm from the operation area towards the upper fornix, 0.3 ml of Healaflow is injected subconjunctivally.

There is a cause-and-effect relationship between the set of essential features and the achieved technical result.

Beginning the operation with corneal paracentesis promotes a smooth decrease in IOP, and filling the anterior chamber with viscoelastic prevents the development of hypotension during surgery and reduces trauma to intraocular structures. PSL measuring 3x3 mm is minimal in size and sufficient in functional characteristics. The introduction of the Healaflow gel-like drainage implant above the PSL and in the area of the upper fornix prevents scarring in the area of the formed filtration cushion and ensures long-term stabilization of the formed outflow path of the intraocular fluid.

The invention is demonstrated by the following examples.

Example 1. Patient V.; 69 years old. Hospitalized with a diagnosis of OD Primary open-angle glaucoma, operated on. Artifakia. Visual acuity on admission 0.3; IOP 35 mm Hg. (according to Maklakov) on a hypotensive regimen. Ophthalmoscopy: The optic disc (OND) is gray, the boundaries are clear, the disc excavation (ED) is 0.9. The macula is without features.

Gonioscopy: The anterior chamber angle (ACA) is open, narrow, at 12 o'clock and 13 o'clock there are zones of anti-glaucoma operations (AGO), blocked by synechiae. Treatment was carried out according to the proposed method, in which a paralimbal incision of the conjunctiva and Tenon's membrane 4 mm long was formed, a PSL measuring 3x3 mm was formed, and 0.2 ml of viscoelastic was injected into the PC through paracentesis. Under the PSL, retreating 0.5 mm from the limbus, a hole was formed in the PC; 0.2 ml of Healaflow was injected above the PSL; at the end of the operation, 0.2 ml of viscoelastic was injected into the PC through paracentesis. Having retreated 5 mm from the operation area towards the upper fornix, 0.3 ml of Healaflow was injected subconjunctivally.

On the first day after surgery, IOP was 13 mm Hg. (pneumotonometry), visual acuity without changes. In the long-term postoperative period (up to 9 months), IOP was 17 mm Hg. (according to Maklakov), stable, compensated without additional use of antihypertensive drugs.

Example 2. Patient R.; 65 years old. Hospitalized with a diagnosis of OS Primary open-angle glaucoma, operated on. Complicated cataract. Visual acuity on admission 0.2; IOP 30 mm Hg. (according to Maklakov) on a hypotensive regimen. Ophthalmoscopy: The optic disc (OND) is gray, the boundaries are clear, disc excavation (ED) is 0.9. Macula without features.

Gonioscopy: The anterior chamber angle (ACA) is open, narrow, at 11 o'clock and 12 o'clock and areas of anti-glaucoma operations (AGO), blocked by synechiae. Treatment was carried out according to the proposed method, in which a paralimbal incision of the conjunctiva and Tenon's membrane 4 mm long was formed, a PSL measuring 3x3 mm was formed, and 0.3 ml of viscoelastic was injected into the PC through paracentesis. Under the PSL, retreating 0.5 mm from the limbus, a hole was formed in the PC; 0.2 ml of Healaflow was injected above the PSL; at the end of the operation, 0.2 ml of viscoelastic was injected into the PC through paracentesis. Having retreated 4 mm from the operation area towards the upper fornix, 0.3 ml of Healaflow was injected subconjunctivally.

On the first day after surgery, IOP was 11 mm Hg. (pneumotonometry), visual acuity without changes. In the long-term postoperative period (up to 12 months), IOP was 15 mm Hg. (according to Maklakov), stable, compensated without additional use of antihypertensive drugs.

15 patients with refractory glaucoma were treated using the proposed method. In all cases, IOP compensation was achieved; no surgical or postoperative complications were observed. The healing processes took place within 2 weeks. The long-term observation period was up to 12 months.

Claims (1)

A method for treating refractory glaucoma, which consists in forming a conjunctival incision and a superficial scleral flap (PSL) with the base to the limbus, an opening in the anterior chamber (AC) with a 27G needle, into which a mini-shunt (MS) model P-50 is implanted using an injector, characterized by that after standard treatment of the surgical field with a blade, a paracentesis of the cornea is performed for 9 hours, a paralimbal incision of the conjunctiva and Tenon’s membrane 4 mm long is formed, a PSL measuring 3 × 3 mm per one third of the thickness of the sclera, 0.2-0.3 is injected into the PC through paracentesis ml of viscoelastic, a 27G needle is used to create a hole under the PSL, 0.5 mm away from the limbus, in the center of the intrascleral cavity under the cut flap, the PSL is fixed on the sides with two interrupted sutures, then 0.2 ml of the Healaflow gel-like drainage implant is inserted over the PSL onto the conjunctiva a continuous suture is applied, 0.2 ml of viscoelastic is injected into the PC through paracentesis, retreating 4-5 mm from the operation area towards the upper fornix, 0.3 ml of Healaflow is injected subconjunctivally.