RU2086218C1 - Method for treating glaucoma - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves forming superficial scleral graft, dissecting limbus strip together with trabecula, making peripheral iridectomy, placing collagenous explant into the bed formed under the graft and having comb shape. The superficial scleral graft is to be cut in full thickness leaving only thin leaf of deep sclera layer on the bed fundus being 0.05-0.1 mm in thickness. The bed is filled with 5% 5-fluorouracyl solution or 0.1% prospidine solution before placing the explant there. In producing collagen, 5-7 mg of 5-fluorouracyl or prospidine is added to collagen and the explant is treated with β-/5-fluorouracyl-2/-acrolein during 9-10 h. EFFECT: enhanced effectiveness of treatment. 1 dwg, 1 tbl

Description

 The invention relates to medicine, namely to ophthalmic surgery and can be used to treat various forms of glaucoma in adults and children with dystrophic altered sclera.

 Currently, glaucoma treatment is carried out by forming an anastomosis between the anterior chamber angle and the intrascleral, suprachoroidal and subconjunctival space.

 Given the mixed nature of the difficulty in the outflow of aqueous humor in the corner of the anterior chamber, sinusotrabeculoectomy is the main and most widespread method for treating glaucoma. This method allows to overcome the trabecular-intrascleral retention of aqueous humor and is used in the treatment of various forms and types of glaucoma.

 However, the method is not without drawbacks, the main of which is the repeated scarring of the created paths of the outflow of aqueous humor, as a result of which this intervention is characterized by unpredictability of results and poor reliability.

 A large number of existing modifications of sinusotrabeculectomy indicates its low efficiency.

 In addition, this method provides for the outflow of aqueous humor mainly into the subconjunctival space, as a result of which it is possible to form cysts of a filtration pad, or external filtration of aqueous humor, or the formation of a giant filtration pad. The presence of such complications leads to the development of a secondary infection, severe hypotension, or to repeated hypertension.

 Another direction of antiglaucomatous interventions, based on the formation of an outflow of aqueous humor into the suprachoroidal space, makes it possible to avoid the formation of filtering pads, but these methods lead to rapid scarring of the outflow of aqueous humor, an unpredictable state of ophthalmotonus, and the possible development of hypotension and ciliochoroid detachment.

 Another direction in glaucoma surgery is intrascleral microdraining proposed by Professor P.I. Lebekhov. Intrascleral microdraining involves the creation of an anastomosis between the anterior chamber and the intrascleral space formed during the operation in the form of channels in the middle layers of the fibrous capsule of the eye. This method is intended to create outflow paths close to natural. It almost eliminates the outflow of aqueous humor under the conjunctiva, while maintaining the outflow into the suprachoroid space through a thin deep leaf of the sclera, as well as into the vascular network of the episclera. However, this method, which ensures the successful treatment of most patients with open-angle glaucoma, turns out to be untenable in patients with thinned or friable sclera, in which the allocation of intrascleral grooves is almost impossible. In addition, the complexity and complexity of the operation of scleral tubule excision make this operation inappropriate in somatically severe patients with glaucoma, in which the intervention time should be limited.

 In addition, due to the technical complexity of monitoring the implementation of scleral tubules, their small size, there is a risk of perforation of the deep layers of the sclera and loss of ciliary body into the surgical wound. At the same time, the formation of scleral canals of insufficient depth leads to difficulty in the outflow of aqueous humor through the thickened bottom of the tubules into the suprachoroidal space. The presence in a number of patients with advanced stages of glaucoma of a thin or loose fibrous capsule makes it impossible to form tubules of the required depth. So, in a number of patients at a far advanced stage of the glaucomatous process, the sclera thickness does not exceed 0.4 mm, as well as in children with congenital glaucoma and glaucoma complicated by high myopia. Such tubules are unreliable, shapeless and quickly scarring, which leads to repeated obstruction of the outflow of aqueous humor.

 There is another method of intrascleral microdraining, which we have chosen as a prototype. It provides the formation of intrascleral outflow of aqueous humor by explantation into the layers of the sclera of drainage made of antimicrobial collagen. Thereby, the procedure for performing intrascleral drainage was simplified, the invasiveness of the operation was reduced by eliminating the process of cutting scleral grooves from the sclera’s own tissue and replacing it with an implant in the form of a “comb” made of antimicrobial collagen. This method provides reliable prevention of intraocular infection, high reliability of the created pathways of the outflow of aqueous humor due to the separation of the superficial and deep leaves of the sclera, the formation of outflow paths close to natural, without the risk of rejection.

 This method also allows you to reduce the time of surgery, is simpler to perform, and expands the possibilities of performing an intrascleral microdrainage operation in patients with thin, stretched, dystrophically altered sclera, as well as in those patients where, due to scleral tissue fracture, there is a threat of rapid overgrowth of newly formed watery outflow pathways moisture.

 However, this method, despite the noted advantages, has its negative sides. Thus, the implementation of the method does not exclude the possibility of filling intrascleral channels with fibrin, which leads to difficulties in the outflow of aqueous humor along the created channels and proliferation of connective tissue in the drainage area and around the explant, as a result of which overgrowth of the created outflow paths of aqueous humor occurs.

 In addition, when performing the operation on the prototype in front of the eyes with a thin, dystrophically altered sclera, the possibility of its further stretching after the operation creates conditions for the difficulty of the outflow of aqueous humor, and can also cause staphylum formation at the site of intervention.

 The 24-48-h treatment of the collagen explant with β - / 5-nitrofuryl-2 / -acrolein used transfers the material into an almost polymeric state, which excludes the possibility of a plastic effect of the explant on a dystrophically altered sclera. However, the operation of the prototype provides for the excision of the middle layers of the sclera. At the same time, the formed thin sclera flap does not provide the necessary completeness of the vascular intrascleral outflow of aqueous humor due to the weak vascularization of this flap.

 The technical result of the present invention is to increase the reliability of the operation, reducing the number of its complications.

 This result is achieved by the fact that in the known method of treating glaucoma, including the formation of a superficial scleral flap, excising a stripe of limbus beneath it with a trabecula, peripheral iridectomy, laying in a comb-shaped collagen explant bed formed under the flap, according to the invention, the surface flap is cut from the entire thickness of the sclera, leaving a thin sheet of the deep layer of the sclera at the bottom of the bed with a thickness of 0.05-0.1 mm, the bed is filled with a 5th solution of 5-fluorouracil before placing the explant in it a 0.1-m prospidina solution, and the manufacture of the explant into the collagen was added 7.5 mg of 5-fluorouracil or prospidina then explant for 9-10 h with a solution b - / 5-nitrofuryl-2 / -akroleina.

 Cutting a surface flap from the entire scleral thickness with a thin, deep layer of 0.05-0.1 mm thick provides reliable protection of the filtering zone from external mechanical and infectious influences by covering it, and also creates optimal conditions for vascular intrascleral outflow of aqueous humor through an abundant network vessels of the surface flap, the thickness of which is 0.3-0.4 mm

 This allows you to save the intrascleral vasculature in full and enhance the intrascleral outflow of aqueous humor, to provide reliable protection of the drainage zone from external influences, which in turn improves the reliability of the operation.

 In addition, cutting a surface flap from the entire thickness of the sclera with leaving a thin deep layer with a thickness of 0.05-0.1 mm eliminates the procedure for excision of the middle layer of the sclera, which in turn allows to reduce time and simplify the operation.

 Filling the bed before placing the explant with a 5-m solution of 5-fluorouracil or a 0.1-m solution of prospidine provides direct contact of the tissues of the filter zone with an antifibroblastic drug.

 It is known that to increase the reliability of the operation, in order to suppress inflammatory exudative and proliferative processes in the operated eyes, leading to overgrowing of the created outflow pathways, various antifibroblastic drugs prospidin, 5-fluorouracil, mitomycin-C are used, but the routes of their administration in the form of subconjunctival injections are used do not provide a sufficient concentration of the drug in the drainage zone, as a result of which the drugs do not give the expected results.

 In addition, this route of administration leads to complications in the form of divergence of the sutures of the conjunctival wound, external filtration of aqueous humor and the development of a secondary infection.

 Our proposed filling of the bed before placing the explant with a 5th solution of 5-fluorouracil or a 0.1-m solution of prospidine provides direct contact of the tissues of the filtering zone with the antifibroblastic drug. This leads to a decrease in inflammatory exudative reactions in the first 3 days after the operation, which is especially important in this period, since direct contact with the antifibroblastic drug prevents filling of the created filtering zone with fibrin films, "plugs", clots that can block the outflow of aqueous humor. At the same time, the filtering zone begins to be actively filled with aqueous humor, rich in enzymes, anti-inflammatory substances, which help to stabilize the filtering effect until the antifibroblast drug leaves the collagen explant.

 The proposed addition of 5-fluorouracil or prospidine to collagen during the manufacture of the explant suppresses inflammatory proliferative reactions 3 days after the operation, which is ensured by the entry of an antifibroblastic drug from the collagen explant over its entire area due to the moisture of the anterior chamber, washing out a molecularly unbound drug from collagen, and subsequently due to the drug entering the surrounding tissues of the eye as the collagen material is depolymerized.

 Thus, the total effect of the antifibroblastic drug on the eye tissue in doses necessary to stabilize the drainage of aqueous humor is up to 1 month.

 To maintain the necessary concentration of the drug during this period, as we have shown, it takes 5-7 mg of 5-fluorouracil or prospidine, which is introduced into the 1st collagen solution, from which plates for the explant are then prepared.

 It is this concentration of the drug in collagen that ensures the suppression of cicatricial fibroblastic processes in the tissues of the drainage zone, without affecting the wound of the conjunctiva and the general condition of the body. Such a concentration of the antifibroblastic drug is the minimum dose that ensures stabilization of the filtering zone, acts for a limited time and at the same time does not interfere with the plastic effect of the collagen explant on thinned, dystrophically altered eye tissues and the transition of the collagen explant into the connective tissue skeleton, preserving its native form.

 Such a metered dose of the drug into the tissues and the regulated nature of the decay and conversion of the exogenous collagen explant is ensured by a 9-10-hour treatment with a solution of b - / 5-nitrofuryl-2 / -acrolein. The specified 9-10-hour modification of collagen preserves its plastic properties and leads to the strengthening of scleral tissue, increase its strength, rigidity (3 times), reduces the ability of the sclera to ectasia and stretching.

 We obtained a similar result in an experiment on chinchilla rabbits during this operation and the subsequent study of biopsy samples of the drainage zone and scleral tissue for rupture.

 Giving the collagen explant anti-fibroblastic activity does not suppress its plastic properties, but ensures their uniform and long-lasting character.

 The drawing shows a diagram of the operation, where 1 conjunctival flap, 2 - superficial scleral flap, 3 thin layer of scleral tissue at the bottom of the formed bed, 4 strip of limbus, 5 drainage explant in the form of a "comb".

 The method is as follows.

 In any quadrant of the eyeball, a conjunctiva is cut 10.0 mm long at 7.00 mm from the limbus. The conjunctival flap (1) is separated to the limbus. A scleral surface flap (2) is isolated with a base to the limb 0.3-0.4 mm thick, 5.0-6.0 mm long along the limb, 5.0-6.0 mm wide in the meridional direction. At the bottom of the formed bed under the surface flap, only a thin 0.05-0.1 mm layer of scleral tissue is left (3). Under the superficial flap with two notches 6.0 mm long, concentric to the limb and 1.0 mm apart from each other, the projection of the trabecula zone on the sclera surface is indicated. A limb strip (4) is excised, limited by incisions and containing the scleral sinus and trabecular tissue. Peripheral iridectomy is performed. The formed scleral bed under a superficial flap is filled with a 5th solution of 5-fluorouracil or a 0.1-meter solution of prospidine. A drainage explant (5) in the form of a “comb” is placed in the bed, the superficial scleral flap (2) is put in place and fixed with four side seams. A continuous suture is placed on the wound of the conjunctiva.

 Example 1. Patient K., 12 years old, was admitted to the eye microsurgery department of Children's City Hospital No 19 named after K. A. Rauchfus 02.09.93, (and / b N 10403) with a diagnosis of Congenital operated glaucoma of the right eye in a far advanced stage with moderately elevated intraocular pressure, complicated by high myopia. Previously, the patient underwent a sinusotrabeculectomy in the right eye twice. The left eye is healthy. Visual acuity of the right eye of 0.06, with a correction of 0.7. Visual acuity of the left eye 1.0. The diameter of the cornea of the right eye is 14.0 mm, the left eye is 11.5 mm. The anteroposterior size of the right eyeball is 27.6 mm, the left 23.5 mm. Refraction of the right eye myopia 7.0 D, left emmetropia. On the fundus of the right eye, glaucomatous excavation of the optic disc is 0.6 of the diameter of the disc (DD). Intraocular pressure (IOP) of the right eye is 29 mm. Hg. Art. left eye 19 mm. Hg. Art. In connection with the non-compensation of IOP, the unsatisfactory outcome of previous operations, with the presence of a dystrophically altered stretched, thinned sclera, a decision was made to conduct surgery according to the proposed method. After separating the conjunctival flap with a length of 10.0 mm and a width of 7.0 mm, a surface sclera flap was selected with a limb length of 6.0 mm, a width of 5.0 mm in the meridional direction with the base to the limb, over the entire thickness of the sclera, leaving a thin deep leaf with a thickness 0.1 mm Under the surface flap with two notches 6.0 mm long, concentric to the limb and 1.0 mm apart, the projection of the trabecula zone on the sclera surface is indicated. The limbus strip was excised along with the trabecular mesh. Peripheral iridectomy. The formed scleral bed under the superficial flap is filled with 0.2 ml of the 5th solution of 5-fluorouracil. A drainage explant containing 5-fluorouracil in the form of a "comb" is laid in the bed. The superficial scleral flap is put in place and fixed by four side seams. Continuous suture on the conjunctiva. The postoperative period was uneventful. Signs of postoperative inflammation were moderate and persisted for up to 3 days. After surgery, the formation of a moderate flat filter pad was noted. Divergence of the edges of the conjunctival wound was not noted. IOP 10 days after surgery was 18 mm. Hg. Art. Visual functions remained the same. During gonioscopy, the presence of a limbectomy opening with explant strips located in it was noted in the intervention zone. Discharged from the clinic on September 18, 93. 2 years after the operation (June 3, 1995, and / b N 12394) visual functions remain the same. The filter cushion is preserved, flat. IOP 19 mm. Hg. Art. without the use of myotics. Excavation of the optic disc decreased to 0.4 disc diameter (DD). Gonioscopy noted the presence of cracks in the created drainage zone.

 Example 2. Patient M., 8 years old, was admitted to the Department of Eye Microsurgery on 02.11.93, with a diagnosis of Secondary uveal glaucoma of the left eye with moderately elevated intraocular pressure. The right eye is healthy. In connection with glaucoma a year ago, the patient underwent a sinusotrabeculectomy operation. Visual acuity of the right eye of 1.0, the left eye of 0.6 (not corrected). The diameter of the cornea of the right eye is 11.0 mm, the left eye is 13.0 mm. The anteroposterior size of the right eyeball is 23.4 mm, the left 25.7 mm. Glaucomatous excavation of the optic disc on the left 0.5 of the diameter of the disc. IOP of the right eye 18 mm. Hg. Art. left eye 28 mm. Hg. Art. Due to the non-compensation of IOP, as well as the risk of inflammatory proliferation and early overgrowth of the outflow paths of aqueous humor, an operation was performed according to the proposed method using a drainage explant containing prospidin, the formed bed was filled with 0.2 ml of 0.1-percent prospidine solution. The technique of surgery is similar to example 1. The postoperative period was uneventful. The postoperative inflammatory reaction lasted up to 5 days, was moderate. IOP stably kept at the level of 18 mm. Hg. Art. The follow-up period was 1.5 years. After 1.5 years (and / b N 2034), 04.-10.05.95, the next control examination was carried out. The level of visual functions has not changed. IOP was maintained at 20 mm. Hg. Art. without the use of myotics. Biometric parameters are stable. The proposed method operated on 10 children aged 7 to 14 years. 50 children were previously operated using traditional interventions, but did not stabilize the glaucomatous process. The observation period for children operated on by the proposed method was 2 years.

 In the table. 1 presents the results of treatment of these patients in comparison with the results obtained in 15 children with glaucoma after conducting operations on the prototype.

 The proposed method for the treatment of glaucoma in comparison with the known has the following advantages.

 1. Improving the reliability of the operation due to: a) eliminating the possibility of overgrowing created drainage paths; b) increase the strength of the sclera in the area of operation; c) increase the volume of filtration of aqueous humor by expanding the intrascleral vascular outflow and activating the uveal outflow through a thin deep layer of the sclera under the superficial flap.

 2. Reducing the number of complications due to: a) suppression of inflammatory exudative and proliferative processes in the tissues of the eye; b) prevent stretching and the formation of staphylae sclera; c) elimination of external filtration of aqueous humor; d) elimination of a secondary infection by direct introduction of an antifibroblastic drug into the drainage zone, strengthening the sclera superficial flap, and increasing the plastic properties of the collagen explant.

 3. Reducing the time and simplifying the operation by eliminating the procedure for removing the middle layers of the sclera.

 The method was developed at the Department of Pediatric Ophthalmology of the St. Petersburg Medical Academy of Postgraduate Education and passed clinical trials in the Department of Eye Microsurgery, Children's Hospital No 19 named after K. A. Rauchfus with a positive effect in 10 children.

Claims (1)

 A method for the treatment of glaucoma, including the formation of a superficial scleral flap, excision of the limb cavity together with the trabecula, peripheral iridectomy, laying in the bed formed in the form of a "comb" collagen explant under the flap, characterized in that the surface flap is cut out from the entire thickness of the sclera, leaving a thin sheet a deep layer of sclera at the bottom of the bed with a thickness of 0.05 0.1 mm, the bed is filled with a 5% solution of 5-fluorouracil or a 0.1% solution of propidine before placing the explant in it; After explant is added to collagen, 5 7 mg of 5-fluorouracil or prospoidin are added, after which the explant is treated with a solution of β- (5-nitrofuryl-2 -) - acrolein for 9-10 hours.

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