RU2815407C1 - Method for preventive intrascleral flange monofixation of an intraocular lens - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to ophthalmosurgery. Cataract phacoemulsification, intraocular lens and intracapsular ring implantation are performed. Before implantation of the intraocular lens, it is pre-pierced with a microsurgical stabbing needle with polypropylene suture 8-0, orienting the prick from the bottom up, and the left free rear end of the suture at distance of 30 mm from the prick is coagulated by means of a thermocauter to form a rear fixing flange. Implantation of the pierced intraocular lens into the capsular sac through the cartridge is carried out together with portion of 8-0 polypropylene suture remaining after the needle is cut off, by orienting it posteriorly from the intraocular lens when using the injector with a flat metal pusher and anteriorly when using the injector with a round silicone pusher. After lens implantation, the intraocular portion of polypropylene suture 8-0 is captured and brought out through the corneocentesis with the formation of an extraocular loop, and its free front end is oriented intraocularly towards the intended place of suturing. A solution containing 1.0 % lidocaine and 0.5 % phenylephrine, as well as a cohesive viscoelastic is introduced intraocularly into the posterior chamber in the area of the intended attachment point. Using a curved injection needle with diameter of 32 gages, a primary scleral puncture is performed 2.5 mm from the limb so that the intraocular injection needle is above the capsular sac in the posterior chamber of the eye, removal of the free front end of 8-0 polypropylene suture from the eye is carried out by inserting it at angle of 130° into a lumen of an injection needle with diameter of 32 gages and removing it from the eye. Intrascleral fixation of the extraocular part of the free front end of polypropylene suture 8-0 is carried out using a bent injection needle with diameter of 32 gages, with polypropylene suture 8-0 inserted into its lumen, by its intrascleral delivery from the primary scleral puncture site to a pre-formed corneal-scleral pocket made using a microsurgical keratoma knife with width of 2.2 mm, removing the free front end of polypropylene suture 8-0 from this pocket and forming a front fixing flange by means of a thermal snapper, which is immersed back into the corneal-scleral pocket.

EFFECT: method enables to minimize the number of surgical interventions, increase the safety of cataract phacoemulsification, provides prevention of postoperative decentration of complex "capsular sac + intraocular lens" in conditions of ligamentous apparatus weakness or subluxation of crystalline lens when performing cataract phacoemulsification.

1 cl, 2 ex, 19 dwg

Description

The invention relates to medicine, namely to ophthalmic surgery, and can be used to prevent postoperative decentration of the “capsular bag + intraocular lens” complex in conditions of ligamentous weakness or lens subluxation when performing cataract phacoemulsification.

Phacoemulsification of cataracts (PEC) with intracapsular implantation of an intraocular lens (IOL) is currently the standard of surgical treatment for patients with lens opacities due to the achievement of the most physiological position of the IOL. However, one of the main contraindications to intracapsular IOL implantation today is lens subluxation, especially pronounced, with the presence of phaco- and/or iridodonesis [Yusef Yu.N. et al., 2020]. The improvement of ophthalmic surgical technology is aimed at performing FEC with intracapsular fixation of the IOL, even with severe disorders of the ligamentous-capsular apparatus [Avetisov S.E. et al., 2015; Yusef S.N. et al., 2013].

At the same time, new techniques for performing FEC introduced into clinical practice do not exclude late spontaneous dislocations of the “capsular bag + intraocular lens” complex in complicated clinical cases, the frequency of which remains quite high.

Thus, according to the Khabarovsk branch of the Federal State Institution National Medical Research Center "MNTK" Eye Microsurgery" named after. Academician S.N. Fedorov” of the Ministry of Health of Russia, about 15,000 dislocations of the “capsular bag + intraocular lens” complex were registered after FEC. The dislocation time varies from 1 to 8 years, but patients began to notice the first signs already 1 year after surgery. At the same time, severe ones (grades 3 and 4) account for 69% of all cases of dislocations, and in 21% of cases it occurs in eyes with initially optimal conditions for performing FEC [Krivko S.V. et al., 2018].

Thus, despite the improvement of ophthalmic surgical techniques, the frequency of dislocations of the “capsular bag + intraocular lens” complex remains very high, does not depend on the initial state of the ligamentous-capsular apparatus and inevitably leads to repeated surgical interventions.

In such conditions, the development of new promising methods for preventing postoperative decentration of the “capsular bag + intraocular lens” complex is becoming increasingly in demand.

The present invention relates to medicine, in particular to ophthalmic surgery, and is intended for the prevention of postoperative decentration of the “capsular bag + intraocular lens” complex in conditions of weakness of the ligamentous apparatus or subluxation of the lens when performing phacoemulsification of cataracts.

There is a known method of transscleral fixation of a posterior chamber intraocular lens (IOL), which includes preliminary making a “hammock” incision at 1/2 the thickness of the sclera at 12 o’clock and cutting out scleral flaps at 9 and 3 o’clock, followed by the formation of two opposing scleral flaps with their bases to the limbus, stitching the supporting elements of the IOL with a thread on two needles and fixing these threads under the prepared scleral flaps after implantation of the IOL in the ciliary sulcus, after which the prolene thread on two needles is carried out using a guide needle with a puncture and puncture under the scleral flaps of 0.5 -0.75 mm from the limbus, through the scleral incision, the middle part of the thread is brought out, cut in half, the resulting ends are tied to the haptic elements of the IOL, which is implanted, pulling it by the threads, and the needles are then additionally passed through the sclera and the sutures are tied.

This method provides effective fixation of a posterior chamber intraocular lens on an aphakic eye, but its use involves the need to perform a large number of incisions that injure the cornea, which are likely to cause postoperative complications. In addition, increased trauma is associated with the need to create scleral flaps and suture the conjunctiva. There is also a risk of external cutting of the sutures securing the IOL to the sclera and the associated risk of postoperative endophthalmitis.

These disadvantages are partially eliminated in another method of fixing an intraocular lens [Patent for invention RU 2446777, cl. A61F 9/007, 2010], which consists in making a corneal incision in the upper sector at 9-12 o’clock in the form of a corneal tunnel incision 1.8-6 mm wide, while additionally opposing peripheral incisions of the cornea are made above the places where the needles were punctured from sclera, and the transscleral passage of this thread through the shell of the eye is carried out at a distance of 1-3 mm from the limbus in the projection of the iridociliary sulcus in opposition or with the help of a guide needle, or without it, with a puncture and puncture or a guide needle or, accordingly, a needle fixed at the end of the thread. The middle part of the thread is removed through a corneal tunnel incision using a microhook or surgical tweezers. When implanting an IOL, it is centered by appropriately pulling up the ends of the thread on which the needles are placed, while at the site of the puncture of the corresponding needle at the ends of the thread, a second injection is made, and the needles attached to the ends of the thread are passed intrascleralally and brought out into the opposition incisions, while the ends of the threads are fixed in the layers of the cornea with interrupted sutures. The thread is selected from a non-absorbable material with a thickness of 8.0 to 12.0, and the injection guide needle is selected with a size of 20 to 27 gauge.

The method allows you to improve vision and obtain a lasting clinical effect while minimizing the number and size of additional corneal incisions, however, it is not intended for prevention, but for secondary fixation of the already deployed “capsular bag + intraocular lens” complex, which is a separate surgical intervention.

The closest to the proposed invention is a method of repositioning a posterior chamber intraocular lens with suturing through the flat part of the ciliary body [RF Patent No. 2691925, cl. A61F 9/007, 2019], which was chosen as the prototype. The method consists in the following: two through punctures of the sclera and ciliary body were previously made in the projection of the haptic elements with a 25 or 23 G needle 2.5 mm from the limbus oppositionally (diametrically opposite) in one of the oblique meridians. Accordingly, one limbal puncture was formed above the puncture sites corneal paracentesis, and two more diametrically located limbal corneal paracenteses were formed in the perpendicular oblique meridian. Through one of the scleral punctures (the first puncture), a needle with a thread was passed in the form of a loop, back first, over the IOL without touching it. The dorsum of the needle was then withdrawn through a corneal paracentesis located 90 angular degrees from the first puncture. Then, into the first puncture (into which a needle with a thread was inserted), a 25 or 23 G needle-guide was passed under the IOL-capsular bag complex, in the area of the near haptic element, and the IOL was centered. The cutting part of the needle with a thread was passed through the needle-guide and they were brought out (the complex - a needle with a thread and a needle-guide) out through the first puncture. Then a “noose” loop was formed from the outside, which was tightened on the haptic element of the IOL. Then a needle and thread were inserted into the first puncture and carried out intrasclerally and intracorneally through both lips of the paracentesis closest to this puncture. The needle and thread were removed from the paracentesis with its back side outwards. An “anchor” knot was formed, the remainder of the thread and needle was cut off, and the knot was immersed in paracentesis. The same surgical actions were performed on the oppositional (opposite side) through the second scleral puncture. Since no incisions were made in the sclera and conjunctiva, after the operation there were no stitches left on the eye that would need to be removed later.

The main disadvantages of the prototype are:

1. not intended for the prevention of dislocation of the “capsular bag + intraocular lens” complex at the time of primary phacoemulsification;

2. is a separate surgical intervention, the purpose of which is to perform secondary fixation of the already dislocated “capsular bag + intraocular lens” complex;

3. the formation of a noose loop is possible only if there is a double thread pressed into 1 needle, which limits the surgeon in choosing a limited range of products on the Russian market;

4. formation of 2 additional corneocenteses of the cornea;

5. the scleral hole from 23-25G needles increases the risk of hemorrhagic complications and can lead to difficulty sealing the eye at the end of the operation;

6. puncture of the capsular bag carries the risk of damage to the anterior hyaloid membrane and loss of vitreous fibers into the anterior chamber of the eye;

7. The method is not applicable to all designs of intraocular lenses: in some cases, due to the special structure of the haptic elements, the formation of a noose loop causes difficulties.

The technical result when using the invention is the prevention of postoperative decentration of the “capsular bag + intraocular lens” complex in conditions of weakness of the ligamentous apparatus or subluxation of the lens when performing phacoemulsification of cataracts.

This technical result is achieved by the fact that the method of preventive intrascleral flange monofixation of an intraocular lens includes phacoemulsification of cataracts, implantation of an intraocular lens and an intracapsular ring, characterized in that before implantation of the intraocular lens it is pre-stitched with a microsurgical piercing needle with an 8-0 polypropylene thread, orienting the injection is made from bottom to top, and the left free rear end of the thread at a distance of 30 mm from the injection is coagulated using a thermal cautery with the formation of a rear fixing flange, the implantation of the stitched intraocular lens into the capsular bag through a standard cartridge is carried out together with the part of the 8-0 polypropylene thread remaining after cutting off the needle, orienting it posteriorly from the intraocular lens when using an injector with a flat metal pusher and anteriorly when using an injector with a round silicone pusher, after implantation of the lens, the intraocular part of the 8-0 polypropylene thread is grabbed and removed through corneocentesis to form an extraocular loop, and its free anterior end is oriented intraocularly towards the intended suturing site, then a solution containing 1.0% lidocaine and 0.5% phenylephrine, as well as a cohesive viscoelastic, is injected intraocularly into the posterior chamber in the area of the intended suturing site, and a primary scleral puncture is performed using a curved injection needle with a diameter of 32 gauge 2.5 mm from the limbus so that the intraocular injection needle is above the capsular bag in the posterior chamber of the eye, removing the free anterior end of the 8-0 polypropylene thread from the eye is carried out by introducing it at an angle of 130° into the lumen of an injection needle with a diameter of 32 gauge and withdrawing it from the eye, intrascleral fixation of the extraocular part of the free anterior end of the 8-0 polypropylene thread is carried out using a curved injection needle with a diameter of 32 gage, with an 8-0 polypropylene thread inserted into its lumen, by intrascleral passage from the site of the primary scleral puncture to the pre-formed corneal scleral pocket, made using a microsurgical keratome 2.2 mm wide, removing the free anterior end of the 8-0 polypropylene suture from this pocket and using a thermal cautery to form an anterior fixing flange, which is immersed back into the corneal-scleral pocket.

The invention is illustrated by the following figures: figure 1 schematically shows the main stages of preventive intrascleral flange monofixation of an intraocular lens. Figures 2, 3 show clinical case 1 (in figure 2, biomicroscopic and OCT (optical coherence tomography) picture of the operated eye 2 hours after surgery using the proposed method; in figure 3, the same, after 2 weeks), sleep fig. .4-5 presents clinical case 2 (in Fig.4 is a biomicroscopic and OCT (optical coherence tomography) picture of the operated eye 2 hours after surgery using the proposed method; in Fig.5 is the same, after 2 weeks).

Under biomicroscopic control using an operating microscope, as shown in Fig. 1, phacoemulsification of the cataract is performed (if necessary, with implantation of an intracapsular ring), after which the factory intraocular lens (1) is stitched with a microsurgical stabbing needle (2) with an 8-0 polypropylene thread (3 ), the injection is oriented from bottom to top, and the left free rear end of the thread (4) at a distance of 30 mm from the injection is coagulated using a thermal cautery (5) with the formation of a rear fixing flange (6), then the intraocular lens (7) is stitched together with the remaining one after cutting off microsurgical stabbing needle (2) part of the 8-0 polypropylene thread (3) is implanted into the capsular bag (8) through a standard cartridge (9), while the remaining part of the 8-0 polypropylene thread (3) is oriented posteriorly to the stitched intraocular lens (7) when using an injector with a flat metal pusher (10), and when using an injector with a round silicone pusher (11) - anteriorly, then the intraocularly located remaining part of the 8-0 polypropylene thread (3) is removed through corneocentesis performed at the stage of cataract phacoemulsification (12) and an extraocular loop of 8-0 polypropylene suture (13) is formed, and the intraocular anterior end of the 8-0 polypropylene suture (14) is oriented towards the intended suturing site (15), then intraocularly into the posterior chamber of the eye (16) in the area of the intended suturing site ( 15) a solution containing 1.0% lidocaine and 0.5% phenylephrine (17), as well as cohesive viscoelastic (18), is introduced, using a curved injection needle with a diameter of 32 gauge (19) a primary scleral puncture (20) of 2.5 mm is made from the limbus (21) so that the intraocularly curved injection needle with a diameter of 32 gauge (19) is located above the capsular bag (8) in the posterior chamber of the eye (16), then the intraocular anterior end of the 8-0 polypropylene suture (14) is removed from the eye by immersing it at an angle of 130° into the lumen of a curved injection needle with a diameter of 32 gage (19) and removing it from the eye, intrascleral fixation of the extraocular anterior end of an 8-0 polypropylene thread (22) is carried out using a curved injection needle with a diameter of 32 gage (19), with inserted into its lumen with the extraocular anterior end of an 8-0 polypropylene thread (22), by intrascleral passage from the site of the primary scleral puncture (20) to a pre-formed corneal-scleral pocket (23), made using a microsurgical knife-keratome (24) wide 2.2 mm, withdrawing the extraocular anterior end of the 8-0 polypropylene suture (22) from the corneal-scleral pocket (23) and using a thermal cautery (5) to form an anterior fixing flange (25), which is plunged back into the corneal-scleral pocket (23).

The main advantages of the proposed method are:

1. allows you to prevent dislocation of the “capsular bag + intraocular lens” complex at the time of performing primary phacoemulsification in conditions of weakness of the ligamentous apparatus of the lens;

2. performed simultaneously with primary phacoemulsification of cataracts, avoiding re-operation;

3. fixation of the intraocular lens is carried out using a single thread, which does not limit the surgeon either in the choice of double threads (the range of which is not widely represented on the Russian market) or in the choice of needle shape;

4. the formation of additional corneocenteses is not provided, which does not increase the invasiveness of the operation;

5. a small hole in the sclera (32 gauge) guarantees high-quality sealing at the end of the operation;

6. complete preservation of the anatomy and relative position of the capsular bag and retrolenticular space without the risk of damage to the anterior hyaloid membrane;

7. The method is applicable to all designs of intraocular lenses and does not depend on the design of the haptic elements;

8. the effective position of the intraocular lens in comparison with its classic endocapsular position does not change, which does not require adjustment when calculating the optical power of the implanted intraocular lens;

9. a minimum number of scleral punctures is provided, which minimizes the risk of developing hemorrhagic complications;

10. the absence of ovalization of the anterior edge of the capsulorhexis preserves the barrier function of the square edge of the intraocular lens, which has a positive effect on the prevention of secondary opacities of the posterior capsule of the lens;

11. The method can be effectively used both with and without implantation of an intracapsular ring.

The essence of the invention is illustrated by the following clinical examples.

Clinical example No. 1

Patient A. was diagnosed with: Initial complicated cataract, pseudoexfoliation syndrome, grade 3 lens subluxation.

Under biomicroscopic control using an operating microscope, phacoemulsification of the cataract was performed with implantation of an intracapsular ring and subsequent preventive intrascleral flange monofixation of the intraocular lens according to the proposed method.

For dynamic monitoring of the position of the intraocular lens in the postoperative period, photorecording of the biomicroscopic picture and OCT of the operated eye were performed.

Already 2 hours after the operation using the proposed method, the centered position of the “capsular bag + intraocular lens” complex was biomicroscopically determined. According to optical coherence tomography, a clinically insignificant tilt of the complex in the horizontal plane was recorded (Fig. 2).

2 weeks after surgery using the proposed method, the correct centered position of the intraocular lens and the predictable achievement of the target refraction were biomicroscopically determined. According to optical coherence tomography data, the absence of tilt of the complex in all planes was recorded (Fig. 3).

Clinical example No. 2

Patient B. Referred with a diagnosis of: Initial complicated cataract, pseudoexfoliation syndrome, grade 2 lens subluxation.

Under biomicroscopic control using an operating microscope, phacoemulsification of cataracts was performed without implantation of an intracapsular ring and subsequent preventive intrascleral flange monofixation of the intraocular lens according to the proposed method.

For dynamic monitoring of the position of the intraocular lens in the postoperative period, photorecording of the biomicroscopic picture and optical coherence tomography of the operated eye were performed.

Already 2 hours after the operation using the proposed method, the centered position of the “capsular bag + intraocular lens” complex was biomicroscopically determined. According to optical coherence tomography, a clinically insignificant tilt of the complex in the horizontal plane was recorded (Fig. 4).

2 weeks after surgery using the proposed method, the correct centered position of the intraocular lens and the predictable achievement of the target refraction were biomicroscopically determined. According to optical coherence tomography data, the absence of tilt of the complex in all planes was recorded (Fig. 5).

Thus, the proposed method is an atraumatic option for preventing postoperative decentration of the “capsular bag + intraocular lens” complex in conditions of ligamentous weakness or lens subluxation when performing cataract phacoemulsification both with and without intracapsular ring implantation, and its effectiveness has been clinically proven.

The proposed method is of great importance for practical healthcare, in particular for minimizing the number of surgical interventions, increasing the safety and effectiveness of cataract phacoemulsification even in the most difficult cases.

Claims (1)

A method of preventive intrascleral flange monofixation of an intraocular lens, including phacoemulsification of cataracts, implantation of an intraocular lens and an intracapsular ring, characterized in that before implantation of the intraocular lens it is pre-stitched with a microsurgical piercing needle with an 8-0 polypropylene thread, orienting the injection from bottom to top, leaving the free rear end the threads at a distance of 30 mm from the injection are coagulated using a thermal cautery with the formation of a posterior fixing flange, the implantation of the stitched intraocular lens into the capsular bag through the cartridge is carried out together with the part of the 8-0 polypropylene thread remaining after cutting off the needle, orienting it posterior to the intraocular lens when using an injector with flat metal pusher and anteriorly when using an injector with a round silicone pusher, after implantation of the lens, the intraocular part of the 8-0 polypropylene suture is grabbed and removed through corneocentesis to form an extraocular loop, and its free anterior end is oriented intraocularly towards the intended suturing site, then intraocularly into a solution containing 1.0% lidocaine and 0.5% phenylephrine, as well as cohesive viscoelastic, is injected into the posterior chamber in the area of the intended suturing site; using a curved injection needle with a diameter of 32 gauge, a primary scleral puncture is made 2.5 mm from the limbus in such a way that so that the intraocular injection needle is above the capsular bag in the posterior chamber of the eye, removal of the free anterior end of the 8-0 polypropylene thread from the eye is carried out by introducing it at an angle of 130° into the lumen of an injection needle with a diameter of 32 gauge and removing it from the eye, intrascleral fixation of the extraocular part of the free the anterior end of the 8-0 polypropylene thread is carried out using a curved injection needle with a diameter of 32 gage, with an 8-0 polypropylene thread inserted into its lumen, by intrascleral insertion from the site of the primary scleral puncture to a pre-formed corneal-scleral pocket, made using a microsurgical knife -keratome 2.2 mm wide, withdrawing the free anterior end of the 8-0 polypropylene suture from this pocket and using a thermal cautery to form an anterior fixing flange, which is immersed back into the corneal-scleral pocket.