RU2570039C1 - Method for surgical management of open-angle glaucoma in patients at age of presbyopia - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: method involves a phacoemulsification with an intraocular lens implantation and a minimally invasive antiglaocomatous intervention. A sclerotic lens is removed without regard to a degree of transparency. The minimally invasive antiglaocomatous intervention is performed by a transscleral graduated puncture of a trabecule with penetrating into an anterior chamber; a diameter of the formed opening is 50 mcm. After one opening is formed, a filtration level of intraocular fluid is visually assessed through a puncture area. If the filtration appears to be low, accessory openings are formed to achieve the visual filtration after the incision wound is dried. If creating more than one opening, their total diameter is expected to be less than 150 mcm, whereas a spread of openings provides their isolated nature.

EFFECT: method provides achieving a postoperative antihypertensive glide path that is a combination of a short-term and long-term antihypertensive effect, making it possible to ensure smooth and long-term normalisation of the intraocular pressure that increases the effectiveness of the surgical intervention.

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Description

The invention relates to medicine, namely to ophthalmology.

Glaucoma is the leading cause of irreversible blindness in the world, which indicates the need for new effective methods of treatment. In the absence of normalization of intraocular pressure (IOP) against the background of the installation of drops from glaucoma, indications for antiglaucomatous surgery are considered. Most often, uncompensated open-angle glaucoma (OAG) occurs in patients at presbyopic age (from 45 years and older). The most widely used are penetrating and non-penetrating interventions for OAG. Penetrating techniques (trabeculectomy and its modifications) are characterized by a high risk of complications associated with a sharp drop in IOP after surgery (hypotension, choroid detachment, hyphema, retinal edema, subatrophy), non-penetrating techniques (non-penetrating deep sclerectomy and its modifications) are characterized by a low risk of hypotonic complications, but a more short-term effect, which is associated with scarring of the intervention zone.

Attempts to reduce the level of hypotonic complications when performing penetrating interventions for glaucoma have previously been used (Alekseev B.N. Tactics of operative diagnostics and pathogenetically oriented microsurgery of open-angle glaucoma // Vestnik Ophthalmology, 1974, No. 2, pp. 26-30): trans-scleral micro-dermatotherapy was performed access, in which micro holes were made on the inner wall of the Schlemm's canal and trabecula using a thin needle electrode for diathermopuncture. Previously, sterile air was introduced into the anterior chamber through a corneal incision to prevent collapse of the anterior chamber and tamponade of microholes in the trabecula with iris tissue, which indicates an excessive outflow of intraocular fluid through puncture holes and is explained by gaping of holes with charred edges, since they are performed by a hot coagulator. To contain the excess flow of intraocular fluid Alekseev BN resorted to hermetic suture fixation of the scleral flap, which also indicates the excessive effect of penetrating intervention and limits its clinical use at present.

Widespread use in clinical practice has received non-penetrating deep sclerectomy (NSGE) (Fedorov S.N., Kozlov V.I. et al. Method for the surgical treatment of open-angle glaucoma // Auth. Svid. SU 1286196 A1 of 09/11/1984): conjunctival incision 6 mm from the limb 8 mm long, separation of the superficial scleral flap 5 × 5 mm with the base to the limb, opening of the Schlemm's canal with removal of its outer wall along the width of the scleral flap bed, removal of the site of the deep layers of the sclera behind the drainage zone of the eye, nodal suturing on the surface flap and nodal sutures on the conjunctiva. The greatest danger of non-penetrating interventions is that neither patients nor ophthalmologists know when the hypotensive effect of the operation will stop and there will be a need to return to the conservative treatment of glaucoma. The time to resume the installation of anti-glaucomatous drops is often skipped, which leads to a rapid increase in IOP, progression of atrophy of the optic nerve, narrowing of the visual field and loss of visual functions.

Further searches to reduce surgical trauma led to the development of a microinvasive method for the surgical treatment of glaucoma (RF Patent No. 2184514, Takhchidi Ch.P., Ivanov DI, Strenev N.V., 2001): the operation begins with a conjunctival incision and the formation of a conjunctival and scleral flaps, which, after excision of the deep layers of the sclera are laid back, the conjunctival incision is performed along the limb at a distance of 0.5-1 mm from it and 1.5-2 mm long, and the superficial scleral flap is cut out 2.5 × 2 in size. 5 mm. The advantages of this method are fast healing processes, short rehabilitation periods and the possibility of repeated repeated anti-glaucomatous interventions in areas not injured during the previous operation. But one should pay attention to the fact that rapid healing in the area of antiglaucomatous surgery leads to a decrease in its effectiveness, as a result of which repeated repeated interventions may be required, which is not an advantage of the technique and questions the advisability of its isolated use as an antiglaucomatous intervention. In addition, the proposed technique suffers from the same drawback as other modifications of HSE - the period of scarring of the filter pad with increased ophthalmotonus is not known, which can lead to delays in the use of additional methods of treatment and the transition of glaucoma to a more severe stage.

The logical result of the search for increasing the effectiveness of non-penetrating glaucoma surgery was the addition of its lens removal in presbyopic patients (Komarova M.G. Optimal terms for lens surgery in patients with different refraction // Modern technologies of cataract and refractive surgery, Moscow, 2013, pp. 87-97 ) is a prototype. Patients with glaucoma (95 eyes, 30 of them with OAG) underwent NGSE and phacoemulsification with implantation of an intraocular lens (FE + IOL), with various degrees of transparency of the lens. The combination of NGSE with lens surgery increased the effectiveness of the intervention, since PV + IOL has a small (2-4 mm Hg), but long-lasting hypotensive effect (Rasin O.G. et al. Hypotensive effect of cataract phacoemulsification in patients with uncompensated primary open-angle glaucoma // Tauride Medical Biological Bulletin - 2012 - v. 15 - No. 2 - part 3 (58) - pp. 191-193; Poley BJ et al. Intraocular pressure reduction after phacoemulsification with intraocular lens implantation in glaucomatous and nonglaucomatous eyes: evaluation of a causal relationship between the natural lens and open-angle glaucoma. // J Cataract Refract Surg. - 2009 Nov-35 (11) - c. 1946-1955; Shingleton BJ et al. Three and five year changes in intraocular pressures after clear corneal phacoemulsification in open angle glaucoma patients, glaucoma suspects, and normal patients. // J. Glaucoma - 2006 Dec-15 (6) - p. 494-498). However, the implementation of non-GSE still has a significant drawback - the unpredictability of the effect of the operation in intensity and duration. It is impossible to predict the effectiveness of NGSE, since during the intervention all patients undergo the same procedure, regardless of differences in the clinical condition of the eye and the degree of retention of the intraocular fluid, the duration of the effect is also not predicted, since scarring of tissues in the Schlemm's canal and scleral cavity may vary significantly in terms in different patients.

In the developed method, the problem was solved of increasing the predictability of the hypotensive effect of surgical intervention with OAG in intensity and duration by optimizing the effect on the trabecular zone of the eye.

The technical result is to provide a smooth and predictable hypotensive effect - a combination of the short-term effect of microgoniopuncture and the long-term effect of FE + IOL, which allows to achieve normalization of ophthalmotonus in the postoperative period and to timely identify the need for additional methods of treating glaucoma.

The specified result is due to the fact that the developed combined intervention has the following advantages:

The performed antiglaucomatous part of the operation is a microinvasive intervention with a limited duration of action (within 2-4 weeks), which allows you to promptly prescribe a medical correction of ophthalmotonus in the postoperative period, if such a need arises.

- The main, and at the end of the postoperative period, PE + IOL becomes the only anti-glaucomatous component, which eliminates the influence on the glaucoma pathogenesis of the volume and weight of the lens growing throughout life (Scammon RE, Hesdorffer M.V. Growth in mass and volume of the human lens in postnatal life. // Arch. Ophthal. 1937, V. 17, p. 104-112), which allows to determine the natural level of ophthalmotonus in patients with glaucoma and artifact, without the influence of NSES.

- The performed hole or holes penetrating into the anterior chamber provide a hypotensive effect that is dosed in intensity. The total diameter of the holes should not exceed 150 μm, since with a larger diameter hypotonic complications are noted according to the experience of using the Express micro shunt of modification P-200 with a lumen diameter of 200 μm (Reyes M, Sarkisian SR “P200 Express Shunt Implantation in Neovascular Glaucoma, Uveitic Glaucoma and Primary Open Angle Glaucoma ”// ARVO, Presentation Abstract, 2010). The choice of the minimum hole diameter of 50 μm is explained by the results of the widespread clinical use of the Express P50 microshunt with a lumen diameter of 50 μm and the results of experimental in vitro studies (Estermann S. et al. Comparative in vitro flow study of 3 different Ex-Press miniature glaucoma device models. // J. Glaucoma, 2013, Mar, 22 (3), 209-14).

- The range of the number of microholes from 1 to 3, depending on the level of filtration, allows to achieve the target pressure individually for each patient, and not rely on the standard implementation of the surgical technique.

- The isolated nature of the microholes helps to dose the hypotensive effect in intensity and duration, which allows avoiding the effect of tissue incision and excessive fluid filtration and ensuring reparative regeneration of 50 microns within 2-4 weeks.

- The microscopic dimensions of the holes are comparable with the sizes of the cells of the trabecular network, which allows us to speak about the physiological effect of microgoniopuncture, enhancing the effect of filtering the liquid through the "sieve" of the trabecular apparatus. Normally, the openings of the trabecular network can reach 18 μm (Kagan II, Kanyukov VN Clinical anatomy of the organ of vision. St. Petersburg: Esculap, 1999, p. 65). The performed puncture with a diameter of 50 μm is so small and atraumatic that it is a way to expand the cells of the trabecular zone to sizes slightly exceeding the physiological ones, and not by cutting or thinning the tissues, which is confirmed by the absence of bleeding when performing the technique and the inability to determine the intervention zone during gonioscopy.

To reduce operational injury, microholes are formed sequentially, with the assessment of visually determined filtration after drying of the surgical wound, which allows you to form the minimum required number of holes.

The hypotensive effect of microgoniopuncture provides normotonicity after PV + IOL, which can provoke an increase in IOP within 2-4 weeks against the background of postoperative edema of the trabecular zone, the presence of cell suspension and residues of viscoelastic in the moisture of the anterior chamber, as well as during the installation of anti-inflammatory drugs containing steroid hormones . The anti-glaucomatous component plays the role of preventive intervention, which eliminates reactive hypertension, which often follows ultrasound removal of the lens on glaucoma eyes (Koretskaya Yu.M. Glaucoma of aphakic and artifact eyes // Glaucoma - 2002 - No. 1 - P. 21-23).

- The use of a sterile steel thread or wire of a given diameter for trabeculae puncture allows the formation of microholes in the elastic trabecular network that are physiological in size, without a tendency to prematurely reduce them, which could occur when using a micro-tool with a diameter of 50 μm with a sharp end, since each the trabeculae looks like a thin strand, in the center of which there is a collagen fiber entwined with elastic fibers (Kagan II, Kanyukov VN Clinical anatomy of the organ of vision I. St. Petersburg: Aesculapius, 1999, p. 63), due to which the trabecular network has extensibility.

The combination of the long-term and short-term antihypertensive effect of combined intervention allows to improve the treatment of OAG, achieve a smooth decrease in IOP, eliminate uncontrolled IOP rises, minimize the need for repeated interventions and completely eliminate the effect of an aging native lens on the progression of glaucoma throughout the patient's life. The clinical result of the application of the developed intervention is satisfied patients who receive not only the predicted normalization of ophthalmotonus, without hypotonic, hypertonic and hemorrhagic complications, but also a simultaneous increase in visual functions, without lengthening the time of postoperative rehabilitation.

The method is as follows.

Under local anesthesia, the conjunctiva is cut 3 mm long in the area of fixation to the limbus for 12 hours, then a perpendicular cut of the conjunctiva 3 mm long is made from the right edge of the cut towards the superior conjunctival arch, which allows you to separate the triangular flap of the conjunctiva and tenon membrane and expose the sclera. If necessary, hemostasis is performed with the tip of the coagulator, then a triangular scleral flap with a size of 2.5 × 2.5 mm is cut out with the base to the limb almost the entire depth of the sclera (without exposing the choroid) and with the opening of the outer wall of the schlemm's canal.

The area of antiglaucomatous surgery is covered with viscoelastic and phacoemulsification of the lens with implantation of the IOL through a corneal incision is performed.

After hydration of the corneal incision and restoration of the ophthalmotonus due to saline injected into the anterior chamber, a metered trabecula puncture is performed under the scleral flap under the scleral flap with penetration into the anterior chamber, with a diameter of the formed hole of 50 μm, for which a sterile steel thread or wire of specified diameter fixed in the needle holder or tweezers. Depending on the level of filtration obtained, which is visually assessed after drying of the area of the surgical wound (for example, with a tuffer), one to several separate holes can be made, while the total diameter of the holes should not exceed 150 microns, and the distance between the holes should ensure their isolated character .

After filtration of the intraocular fluid through the puncture zone is achieved, the scleral flap is placed in the scleral bed, the conjunctival flap covers the intervention zone and fixes with one nodal suture in the area of the angle of the L-shaped incision.

Example No. 1

Patient L., 75 years old, turned for surgical treatment of uncompensated open-angle glaucoma (OSH) III-b of both eyes. Over the past 12 years, she has received conservative treatment. By the time of the preoperative examination, she used 3 types of antiglaucomatous drops, which did not lead to compensation of intraocular pressure (IOP).

The narrowing of the fields of vision is concentric to 30 degrees.

Biomicroscopy: the eyes are calm, the cornea is transparent, the anterior chamber is of medium depth, the iris is atrophic, partial destruction of the pigment rim, the pupil is 3 mm in diameter, the reaction to light is flaccid, the lens is sclerosed, initial opacities under the posterior capsule are noted, the fundus reflex is pink, pale optic nerve disc, the boundaries are clear, E / D = 0.7-0.8 deep, a / v = l / 2, the arteries are narrowed, sclerosed, the veins are thickened, full-blooded, ML - reflexes are smoothed, no focal pathology is revealed. When gonioscopy: the anterior chamber angle is open, pigmentation 2 tbsp.

The patient underwent combined surgery according to the developed technique in the right eye, and after 1 month - in the left eye. Operations and the postoperative period were uneventful. There was a smooth normalization of ophthalmotonus, without hypotonic conditions. In the first day after surgery, the IOP was 15-16 mm RT. Art., 1 week after the intervention - 17-18 mm RT. Art., after 1 month - 22-23 mm RT. Art., which required the appointment of small doses of selective beta-blocker. Against the background of drug monotherapy, the ophthalmotonus stabilized at 14-16 mmHg. Art. within 14 months of observation. The visual acuity of both eyes increased to 0.9 without correction, the field of view expanded by 5-10 degrees.

Example No. 2

Patient K., 53 years old, was under observation after previously undergoing successful surgery of the left eye ophthalmic III-b. 2 years after performing a non-penetrating deep sclerectomy, the patient felt visual impairment of the left eye, periodic aching pains in the eyeball and in the left half of the head, he did not immediately seek specialized medical help. On examination, the left eye is calm, the optical media are transparent, the anterior chamber is deep, the destruction of the pupil pigment rim, the optic disc is pale with a gray tint, the boundaries are clear, E / D = 0.9, a / v = 2/3, ML - the reflexes are smoothed. The gonioscopic angle of the anterior chamber is open, pigmentation is 2-3 tbsp.

The field of view of OD is within normal limits, OS is concentrically narrowed to 5 degrees from the fixation point (tube).

The patient underwent a preoperative medical correction of the ophthalmotonus of the left eye, then the developed combined intervention was performed. The operation and the postoperative period were uneventful. In the first day after surgery, the IOP OS was 14 mm RT. Art., after 1 week - 17 mm RT. Art., after 1 month - 20 mm RT. Art. After the administration of the prostaglandin analogue, the IOP OS stabilized at 12-14 mm Hg. Art. during the entire observation period (18 months). The visual acuity of the left eye increased to 0.6, the field of view expanded by 3-5 degrees.

Claims (3)

1. A method for surgical treatment of open-angle glaucoma in presbyopic patients, including performing phacoemulsification of a sclerosed lens, regardless of its degree of transparency, with implantation of an intraocular lens and microinvasive anti-glaucomatous intervention, characterized in that the micro-invasive anti-glaucomatous intervention is performed by micropuncture access to the trabec the front chamber, with a diameter of the formed hole 50 μm open The steps are performed sequentially, evaluating after each formation the level of the obtained filtration of intraocular fluid through the micropuncture zone, the holes are formed until a visually detectable filtration is achieved, and the distance between the holes should ensure their isolated character. 2. The method according to p. 1, characterized in that the total diameter of the holes does not exceed 150 microns. 3. The method according to p. 1, characterized in that for micropuncture trabeculae use a sterile steel thread or wire of a given diameter.