RU2118142C1 - Method of treating glaucoma - Google Patents

Abstract

FIELD: ophthalmology. SUBSTANCE: capillary-type drainage channel is formed in deep layers of sclera, its walls being own sclera and a fragment of amniotic membrane. Intraocular fluid is drained into intrascleral ways. Postoperative complications are eliminated because of using natural material with unique properties, including antiinflammatory, immunosuppressive, antianginoidal, and trophic effects. EFFECT: improved treatment efficiency.

Description

 The invention relates to medicine, in particular to ophthalmology, and can be used for surgical treatment of both primary and secondary glaucoma.

 The glaucomatous process is accompanied by a persistent increase in intraocular pressure (IOP), changes in visual fields, gradual atrophy of the optic disc and in the terminal stage leads to irreversible blindness, sometimes accompanied by the need for enucleation of the eyeball.

 Known methods of treating glaucoma by antiglaucomatous operations: deep scleroectomy, subscleral sinusotrabeculectomy, goniotomy, sinusotomy, etc. and their modifications (Krasnov M.M.Glaucoma microsurgery. - M., 1974; A. Nesterov. Primary glaucoma. - M., 1982; Klin. Mbl-Angenheilk, 1990, Bd. 196. - 5, s. 387 - 388; Eye. - 1990, v. 4 - 3, p. 425 - 438 and others), using laser technology (Herald ophthalmol. - 1992, N 4 - 6, p. 40 - 41, etc.), epibulbar administration of drugs, oral and parenteral administration of antihypertensive drugs, physiotherapeutic meth rows (Red Journal "Vestnik ophthalmia..." -. M., 1989, 8, etc...).

 We investigated the biological and functional effect of the new method of surgical correction of increased IOP proposed by us for primary and secondary glaucoma with the formation of an intrascleral drainage tubule by the type of a water vein and the use of biological tissue - amnion - as an immunosuppressive, protective, forming the upper wall of the tubule of the interscleral graft.

 A known method of treating glaucoma with the formation of intrascleral drainage tubules from the lens capsule (M.M.Krasnov et al. // Vestn. Ophthalm. - 1987, N 6, t. 103, p. 6 - 11). After cutting out the episcleral flap and the formation of an anti-glaucomatous perforation hole in the anterior chamber of the eye, a lens capsule is placed on the scleral bed over which the episcleral flap is fixed in its original position. The effect should be due to the formation of folds of the elastic capsule of the lens, which the authors consider as drainage tubules. The lens capsule can occupy 3 positions: - between the outer and inner layers of the sclera; - in the anterior chamber, crushing the root of the iris; - in the suprachoroidal space.

The presented method of treatment is, of course, interesting from the point of view of using biological tissue for the formation of drainage tubules. However, we believe that despite the described positive effect, this method of treatment has several disadvantages that should be taken into account when using biological material:
it is impossible to normalize and calculate the size (size) of the drainage tubules formed by the arbitrary folding of the lens capsule;
the immunological properties of the lens capsule are not proven, while the tissues used in the treatment of glaucoma should have not only immunological tolerance properties, but also a certain immunosuppressive quality, which could guarantee the absence of postoperative complications;
the lens capsule may be vascularized;
to obtain a lens capsule, it is necessary to perform a lens extraction operation for cataract - senile, traumatic, congenital, etc. which it is normal with a clear crystalline lens) trophic effect;
the contact of any foreign tissue with the elements of the choroid (the root of the iris or the ciliary body when the lens capsule 2 and 3 are described by the authors) can lead to the appearance and development of sluggish uveitis with subsequent dystrophy of the ciliary body. This phenomenon can be aggravated when using the lens capsule obtained during surgery for traumatic cataracts, toxic or radiation injuries (a clear differentiation of the etiology with mature or complete cataracts is not always possible);
a thin folded lens capsule can fill in the area of sinusotrabeculectomy;
the formation of a filtration cushion in the postoperative period, due to which the effect of the operation is carried out, indicates the outflow of intraocular fluid (HPW) under the conjunctiva. The filtration cushion is the most vulnerable area accessible for infection (especially when a cystic cushion is formed), the conjunctiva in the filtration zone undergoes a process of dystrophy;
the postoperative period requires mandatory correction with anti-inflammatory drugs.

 These disadvantages are absent in the proposed method of treatment, in which an artificial capillary type drainage tubule is formed in the deep layers of the sclera, the machines of which are the sclera on three sides, and the amnial tissue fixed in the stretched position is on top.

 IHV transport is carried out under the action of increased IOP through trepanation sinotrabecular and basal iridectomy openings formed by an intrascleral tubule (similar to a water vein) to the intrascleral outflow tract.

 The technical solution of antiglaucomatous inter-scleral bio-drainage of the eye.

 Conjunctival flap 7.5 to 8.0 mm high, conjunctival incision 4 to 6 mm long. A flap 3–5 mm wide, 6.7–7.0 mm long, 1/3 of the sclera thickness (about 0.2 mm) is formed on the episclera site, free from large episcleral vessels (to avoid injury to the latter). Its dimensions depend on the individual size of the eyeball and the intensity of the location of the blood vessels. The flap leans back up. After the localization of the sinotrabecular zone in it through an incision (to maintain the tone of the eyeball), a section of a trepanation hole with a diameter of 0.6 - 1.0 mm is planned, a direct continuation of which is the intrascleral tubule formed in the deep layers of the sclera (0.2 - 0.3 mm height) of 5.0 • 0.6 - 1.0 mm. A dark ciliary body is visible through the scleral bottom of the tubule, the integrity of which is not broken. Trepanation of the sinotrabecular zone with a diameter of 0.6 - 1.0 mm, basal iridectomy. Then, above the outflow zone formed by the operative access, the segment of the amniotic membrane (5 - 7 • 8 mm), the edges of which extend 1.5 - 2.0 mm beyond the periphery of the cut, is fixed by interrupted sutures in the tension state to the episclera. The episcleral flap carved out at the initial stage of the operation is laid on the amnion and fixed at the corners with interrupted sutures through the amnion and deep scleral layers. Continuous suture on the conjunctiva.

 Thus, we have a two-stage intrascleral drainage zone, at the bottom of which there is a microchannel filling through the trepanation hole with intraocular fluid, and a zone of additional fluid resorption, which can also serve as a transitional container for transporting fluid from the eye cavity to the intrascleral outflow paths. Experimental studies have shown that after 5 - 7 days endothelial cells begin to migrate into the microchannel, subsequently completely lining its bottom and walls. Due to the capillarity effect, liquid from the chambers of the eye constantly enters the microchannel, which prevents it from overgrowing during the first 5-7 days of the initial stage of the formation of an artificial vessel through the migration of endotheliocytes.

 The positive results of experimental and immunological studies have allowed us to use the amniotic membrane for the first time to treat glaucoma. The high significance of the use of namely amnion lies in its antiangioid (preventing vascularization), protective, anti-inflammatory, antibacterial, antiviral, trophic properties (Galiullina R.Sh. Keratoamnioplasty. - 1992; Scane T., Hawkins D. // Brit. J. Obstet. Gynecol. - 1986. - 93, N 6. - P. 577 - 581; Yamada K. et al. // Acta Obstet. Gynecol. Jap. - 1986, 38, N 9, p. 1535 - 1538; RaoT.V . et al. // Arch. Surg., 1981, 116, p. 891 - 896). The amniotic membrane has the ability to suppress the development of immune responses, thus exerting a pronounced immunosuppressive effect (Lomakin M.S. et al. // Akush. And Gynec. 1980, N 4, p. 19; Gorlina N.K., Golovistikov I N. Immunology, 1980, N 2, pp. 38-40; Galiullina R. - 2 ICP, Japan, 1994, p. 107). Along with this effect, the amniotic membrane has a lysing effect on inflammatory complexes, polymorphonuclear leukocytes, free red blood cells, preventing the development of postoperative complications and normalizing the vital activity of pathologically altered tissues in secondary glaucoma.

 Nature itself created the amnion as a membrane to protect the fetus from any pathogenic external influences. Amnion is a young, biologically active tissue that carries vital functions. Amnion has a very rich and valuable biochemical composition: hormones, enzymes, prostaglandins, metal ions, complement factors, elastin, collagen, activated substances, type-specific antibodies to antigens of a number of bacteria and viruses, immunoglobulins and many other active components.

 The amniotic membrane is obtained by cesarean section or sterile during childbirth. Fresh washed and treated or sublimated fabric is used. The sublimation method provides sterility, allows easy transportation of the material, long-term storage, does not require additional costs associated with the use of preservatives. Amnion is a widely available material with the properties of vector permeability for nutrients, high plasticity, elasticity, low elongation ability, it is easily and reliably fixed by sutures that are not cut through the elasticity of the fabric. From one amniotic membrane, up to 300 complete samples can be obtained.

Due to the above properties, the complete absence in the postoperative period of any complications is noteworthy. The postoperative period does not require injections of anti-inflammatory drugs under the conjunctiva or parabulbar - you can limit yourself to using the drug epibulbar in drops (sofradex, mesatone) for 5 to 7 days. The normal functioning of the drainage operating area is accompanied by an intrascleral outflow of intraocular fluid, there is no filter cushion. We observed the normalization of tonographic indicators, the expansion of the field of view by 5 - 12 ^o . The visual acuity associated with secondary clouding of the lens practically did not change - obviously, the trophic effect of the amniotic membrane affects. Staying in a hospital after surgery is limited to 4 to 5 days. The proposed method operated on 84 patients, of which 56 people had a follow-up period of 3 years, during which there was no relapse in the rise of IOP and associated complications.

 The treatment method is illustrated by the following examples.

Example 1. Patient N., 68 years old, medical history N 836. Received in railway station clinic with a diagnosis of Open-angle glaucoma (OAG) III C, complicated initial cataract of the right eye, OAG II B of the left eye. Right eye: Vizus - 0.3, tonometric IOP (P _t ) - 38 mm RT. Art., true IOP (P _o ) - 56.4 mm RT. Art. , the coefficient of ease of outflow (C) - 0.03 mm ³ / min • mm RT. Art. Concentric narrowing of the visual fields, from the nose - up to 15 ^o , from above - up to 20 ^o . Antihypertensive therapy contributed to a decrease in P _o to 43.6 mm RT. Art. The anterior chamber angle (CCP) is wide, with moderate endogenous pigmentation. The patient was offered an anti-glaucomatous operation - inter-scleral bio-drainage of the right eye, which was performed with the consent of the patient. In order to avoid ciliochoroidal detachment in the postoperative period with high IOP (more than 33 mm Hg), it is recommended to supplement the glaucomatous surgery with posterior trepanation of the sclera, which was done in this case. On the 1st postoperative day, P _t 21 mm RT. Art., there is no filtration pad, which indicates the functioning of the intrascleral outflow paths - there is no danger of conjunctival dystrophy in the operation area and infection through the filtering zone. Under the conjunctiva, 1 mg dexazone and 1% mesatone 0.3 ml were injected once. 5 day after surgery P _t 23 mm RT. Art., visus - 0.3. The field of view expanded from above by 5 - 6 ^o . There are no signs of choroidal detachment, edema of the elements of the fundus, the filtration zone is functioning. The patient was discharged with the recommendation of outpatient observation. Inspection after 1 month: visa - 0.3, P _t - 21 mm RT. Art., P _o - 16.4 mm RT. Art., C - 0.5 mm ³ / min • mm Hg. Art. The field of view is the same. Consultation after 3 years 1 month: Visa - 0.3, P _t - 23 mm Hg. Art., P _o - 17.1 mm RT. Art., C - 0.5 mm ³ / min • mm Hg. Art. The field of view from the nasal side did not change, expanded from above by 7 ^o . It is used by honey drops as an anti-cataract.

Example 2. Patient K., 58 years old, medical history N 1054. Received with a diagnosis of Secondary post-traumatic glaucoma with high IOP, complicated incomplete cataract of the right eye. Right eye: visual acuity - 0.1, P _t - 33 mm RT. Art., P _o - 52.6 mm RT. Art., C - 0.01 mm ³ / min • mm Hg. Art. Field of view - concentric narrowing to 30 - 35 ^o . CPC is narrow, multiple gonosynechia, moderate pigmentation. Antihypertensive therapy did not reduce IOP. The foregoing surgical intervention on the right eye is proposed, the consent of the patient is obtained. 1 day after surgery: P _t - 17 mm RT. Art., the previous visa. Intrascleral outflow functions. Given the multiple gonosynechia, under the conjunctiva N 3 injections of dexazone 1 mg, lecozyme 1 unit. 4 day: P _t - 20 mm RT. Art., visus and field of view without dynamics. The number of synechiae in the CPC has decreased, long-standing dense adhesions are preserved. Discharged during normal functioning of the drainage zone on day 6, was observed in the clinic 1 time per month. Inspection after 2.5 years: visual acuity - 0.08, P _t - 22 mm RT. Art., P _o - 16.8 mm RT. Art., C - 0.7 mm ³ / min • mm Hg. Art. Field of view without dynamics, intrascleral filtration, cataract phenomena slowly increase.

Example 3. Patient V., 43 years old, medical history N 1048. Received with a diagnosis of: Prolonged acute attack of angle-closure glaucoma of the left eye. Intense pain in the eyeball, radiating to the paraorbital tissue, head. He was ill for 3 months, refused surgical treatment, used 2% pilocarpine in drops 4 times a day and diuretics. Locally: edema of all layers of the cornea, anterior chamber 2 mm deep in the center, pupil 1 mm in diameter, CPD closed, single tender synechiae. P _t - 36 mm RT. Art., P _o - 56.1 mm RT. Art., C less than 0.01, Visus - projection of light from the temporal side. The use of antihypertensive drugs is not effective, diuretics temporarily (for 6 hours) decreased P _m to 33 mm Hg. Art., the next day P _t - 38 mm RT. Art. With the consent of the patient, an operation was performed - inter-scleral bio-drainage, posterior trepanation of the sclera of the left eye. Already at the end of the surgery, corneal edema significantly decreased, the pupil expanded to 3 mm in diameter. A day after the operation: corneal endothelial edema persists, anterior chamber 3 mm deep, pupil 3 mm, P _t - 16 mm Hg. Art., the operating area is calm, there are no signs of subconjunctival filtration. Drops used: 1% gomatropin 3 times a day, Sofradex 4 times a day; under the conjunctiva, 4% taufon was injected once (as a trophic component). 2 day: the cornea is transparent, the anterior chamber is 3.1 mm deep, the pupil is 5 mm, P _t - 20 mm RT. Art. From the temporal side, objective vision appeared at a distance of 14 cm from the eye behind a thick "fog". Day 4: the operating area is calm, intrascleral filtration, the optical media are transparent, the anterior chamber is 3 mm, the pupil is 5 mm, P _t is 19 mm Hg. Art. The field of view is determined in the temporal part in the interval 35 - 50 ^o , a vertical length of 15 ^o up, 7 ^o down. Subtotal atrophy of the optic disc. Discharged on day 5, was observed on an outpatient basis in the clinic, the condition stabilized. Examined after 3 months: visus - 0.01 eccentric from the temporal side, P _t - 21 mm RT. Art., temporal field of view between 38 and 48 ^o , a height of 15 ^o . Observed for three years, the achieved functional parameters are preserved.

 Patients were discharged with rehabilitation possible for this stage of the glaucomatous process during an inpatient postoperative treatment period of an average of 5 days. In no case was a reactive amniotic transplant syndrome observed. On the contrary, in the first days after the operation, attention was drawn to the absence of usual hyperemia during the intervention, and good tonographic parameters.

 Comparative treatment of patients was carried out according to the prototype method (24 people), which showed that the treatment time is 9-12 days, the level of functioning of the filter pad and its type (flat, cystic, etc.) are unpredictable, anterior uveitis was observed in 4 cases, valued by us as a hyperreactive response to implantation of the lens capsule (stopped by glucocorticoids). The negative aspects of the method described above took place.

 Thus, in comparison with the method adopted by us for the prototype, the proposed method of treatment allows to reduce the length of stay of the patient in the hospital by half, and the number of complications reduces to almost zero.

 The proposed method of treatment will reduce the postoperative period of a patient’s stay in hospital by an average of 5 days, eliminates complications, significantly reduces the economic costs of anti-inflammatory, enzymatic, trophic drugs.

 The method is not time-consuming, with the right technical performance guarantees high quality anti-glaucomatous intervention and the absence of postoperative complications.

Claims (1)

 \\\ 1 A method for treating glaucoma by forming an intrascleral drainage zone using an inter-scleral biograft as part of its wall, characterized in that the amniotic membrane is used as a graft.