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GLUED IOL: GLUED INTRASCLERAL FIXATION OF POSTERIOR CHAMBER IOL

INTRODUCTION : Glued IOL is a new surgical technique for implantation of a posterior chamber IOL with the use of biological glue in eyes with deficient or absent posterior capsules. A quick-acting surgical fibrin sealant derived from human blood plasma, with both hemostatic and adhesive properties is used. IOL implantation in eyes that lack posterior capsular support has been accomplished in the past by using iris-fixated IOL, anterior chamber IOL and transscleral IOL fixation through the ciliary sulcus or pars plana. Surgical expertise, prolonged surgical time, suture-induced inflammation, suture degradation, and delayed IOL subluxation or dislocation due to broken suture are some of the limitations in sutured scleral-fixated IOL. It is also difficult and time-consuming, requiring minute and perfect adjustment of suture length and tension to ensure good centration of the scleral-fixated IOL. INVENTION: Sutureless intrascleral fixation of posterior chamber IOL was first described by Dr.Gabor Scharioth from Germany. This technique was further modified by making scleral flaps and creating scleral pockets for tucking the haptics.The flaps are then reattached to the bed with the help of Glue. HISTORY : On 22nd January 2008 ,Dr. Agarwal’s Eye Hospital, India’s one of the leading eye care provider, successfully performed Intraocular lens (IOL) implant on Anandhi, a 4 year old girl, using Glued IOL technology. For the first time in the World, tissue glue had been used to fix an intraocular lens in an eye.This new surgical procedure was invented & performed by Prof. Amar Agarwal, Chairman, Dr. Agarwal’s Eye Hospital, Chennai. Anandhi had a history of injury in her right eye 3 months ago while bursting crackers. She underwent emergency surgery for lens removal due to severe injury to the lens and routine IOL, which was specific for such cases. After 1 month, when the child came for follow up, it was found that there was a decenteration of IOL. The parents noted the child’s difficulty in performing activities in right eye. Under general anaesthesia Prof. Amar Agarwal removed the already existing IOL and placed the IOL using Glued IOL technique.

INDICATION: Glued IOL can be done both as a primary and as a secondary procedure. As a primary procedure it can be done in all cases of intraoperative posterior capsule rupture. It can also be done in all cases of subluxation or dislocation of lens eg. Marfans syndrome,traumatic dislocation of lens etc. As a secondary procedure it can be done in all the aphakic cases or can also be done as a part of IOL exchange following an AC IOL, subluxated or dislocated IOL.

FIBRIN GLUE Fibrin glue has been used previously in various medical specialties as a hemostatic agent to arrest bleeding, seal tissues and as an adjunct to wound healing. It is available in a sealed pack that contains freeze-dried human fibrinogen (20 mg/0.5 mL), freeze-dried human thrombin (250 IU/0.5 mL), aprotinin solution (1,500 KIU in 0.5 mL), one ampoule of sterile water, four 21-gauge needles, two 20-gauge blunt application needles, and an applicator with two mixing chambers and one plunger guide. Preparation of glue: The vials are placed in a water bath which is preheated to 37 degrees for 2 to 3 minutes. 0.5 cc of distilled water is then added to thrombin vial whereas aprotinin is mixed with fibrinogen. Both the components are then filled in separate syringes and a 26 G needle is attached to it.

TECHNIQUE : The glued IOL technique consists of making two partial thickness scleral flaps exactly 180° apart appx. 2.5mm by 2.5 mm (Figure 1) followed by a sclerotomy with a 22-gauge needle 1 mm from the limbus ( Figure 2). A 23 G vitrectomy cutter is introduced from the sclerotomy site and thorough vitrectomy is done removing all the vitreous tractions (Figure 3). A corneal tunnel is fashioned and then a 25-gauge MicroSurgical Technology forceps or 23 G Glued IOL forcep is passed through the sclerotomy site and the tip of the leading haptic of IOL is grasped( Figure 4), which is then externalised and brought out onto the ocular surface (Figure 5). Similarly the trailing haptic is then externalised (Figure 6). Scleral pockets are made at the edge of the flap with a 26-gauge needle (Figure 7) just parallel to the sclerotomy site, into which the two haptics are then tucked for additional stability (Figure 8). The scleral flaps are then glued back into place using biological glue (Figure 9). The IOLs that can be used are the three-piece foldable IOLs with slightly firm haptics or a three- piece non-foldable IOL. The glue is then used to seal the conjunctival closure(Figure 10). Figure 11 shows the process of externalisation of haptics in the cut section of human eye.

Fig.1

Fig.2

Fig.3 Fig.4 Fig.5 Fig.6

Fig.7 Fig.8 Fig.9 Fig.10

Fig.11  VERTICAL GLUED IOL : The vertical corneal diameter is always less than horizontal diameter. In cases of big eyes, the least corneal diameter (i.e. at 6’o clock & 9’ o clock) along the vertical axis can be chosen for making the sclera flaps. The IOL’s currently available in the market are 13 mm in length. Choosing the least corneal diameter allows extra length of the haptic available for tucking and so gives extra stability. Advantages: 1. Comfortable temporal seating 2. Vortex veins are not disturbed. So there is less bleeding. 3. The flaps get hidden beneath the lid margin in the fornices. So cosmetically it looks better. 4. Extra length of the haptic is available for tucking. This gives more stability to the IOL.

HANDSHAKE TECHNIQUE: This technique is used for easy externalisation of haptics especially for externalisation of the trailing haptic and in cases of small pupil. Two glued IOL forceps or MST forceps are needed for this technique. The haptic is hold with one forcep which is introducd from the corneal tunnel and the other forcep is introduced from the sclerotomy site.The tip of the haptic is then traced and is caught followed by externalisation from the sclerotomy site. Visualisation of the tip of the haptic becomes very difficult in cases of small pupil. Although iris hooks can be used the handshake technique simplifies the procedure.The exteriorization of the haptics is a key step in the glued IOL. Since the surgeon is maneuvering with both hands simultaneously, one hand injecting the IOL while the other grasps and exteriorizes the haptics, he/she needs to be familiar with the handshake technique as a means of transferring the haptic from one hand to the other. If one of the haptics is not caught or if it gets released accidentally after grasping it, the situation can be easily resolved using this technique. It utilizes two MST forceps, one of which holds one haptic. Depending on ease of access, the other MST forceps is introduced through the opposite sclerotomy or through the side-port. The first hand then transfers the haptic into the second MST forceps such that the first hand now becomes free. It is essential to hold the haptic at its tip before exteriorizing it so that it doesn't snag on the sclerotomy while being brought out. For this reason, this handshake transfer of the haptic between the two MST forceps is continued till the tip of the haptic is caught by the forceps on the side to which the haptic is to be exteriorized. This technique thus allows easy intra-ocular maneuvering of the entire haptic or IOL within a closed globe system.

MULTIFOCAL GLUED IOL: Multifocal glued IOLs have been done with the ReZoom (Abbott Medical Optics), ReSTOR (Alcon) and Tecnis (AMO) IOLs. This makes it possible to offer the accommodative IOL advantage even to patients with an absent capsule. These IOLs cannot be implanted via any other mode, including suturing. The modified Prolene polyvinylidene fluoride haptic in these IOLs helps in being more stiff as well as having superior memory. Sutured scleral-fixated IOLs in pediatric eyes have been known to be associated with problems. Good results are reported in multiple complicated pediatric glued IOL situations, such as homocystinuria with subluxation, aniridia with cataractous subluxated lens, Weill-Marchesani syndrome with microspherophakia and glaucoma. In dislocated posterior chamber PMMA IOL, the same IOL can be repositioned, thereby reducing the need for further manipulation. Multifocal IOLs allow good vision at a range of distances. Monofocal intraocular lenses which are commonly available give clear point of focus in the distance or closer, but you can choose only one focal point. Multifocal intraocular lenses are designed to avoid the need for glasses by providing two or more points of focus. These intraocular lenses are intended to be placed in the capsular bag. Until recently, it was difficult to provide multifocality for patients who had complicated cataract surgeries which lack normal capsules. Aphakia with deficient capsule has been a limitation for obtaining multifocality. Now multifocality is possible even in complicated cataract surgeries by the Multifocal Glued IOL procedure. In this multifocal IOL implantation is done even in eyes with large posterior capsular rupture (PCR) and aphakias with deficient posterior capsule. ANIRIDIA GLUED IOL: The glued IOL technique can be used in cases in which there is aphakia with aniridia. In such a cases one can use an aniridia IOL which has got an artificial iris with the IOL component. Thus we can get an aniridia glued IOL.

DISCUSSION: This fibrin glue-assisted sutureless posterior chamber IOL implantation technique would be useful in many clinical situations in which scleral-fixated IOLs are indicated, such as luxated IOL, dislocated IOL, zonulopathy or secondary IOL implantation. In a case with a dislocated posterior chamber PMMA IOL, the same IOL can be repositioned, thereby reducing the need for further manipulation. Externalization of the greater part of the haptics along the curvature stabilizes the axial positioning of the IOL and thereby prevents any IOL tilt. In the 12 eyes of our 12 patients, no complications such as postoperative inflammation, hyphema, decentration, glaucoma or corneal edema have been seen after a regular follow-up. There is less incidence of uveitis-glaucoma-hyphema syndrome in fibrin glue-assisted IOL implantation as compared with sutured scleral-fixated IOL implantation. In the former, the IOL is well stabilized and stuck onto the scleral bed and thereby has decreased intraocular mobility; in the latter, there is increased possibility of IOL movement or persistent rub over the ciliary body. Visually significant complications due to late subluxation, which has been known to occur in sutured scleral-fixated IOLs, may also be prevented as sutures are avoided in this technique. Moreover, the frequent complications of secondary IOL implantation, such as secondary glaucoma, cystoid macular edema or bullous keratopathy, were not seen in any of our patients. Another important advantage of this technique is the prevention of suture-related complications such as suture erosion, suture knot exposure, or dislocation of IOL after suture disintegration or broken suture. The other advantages of this technique are the rapidity and ease of surgery. The technique eliminates tying the difficult-to-handle 10-0 Prolene suture to the IOL haptic eyelets, the time required to ensure good centration before tying down the knots, and the time required for suturing scleral flaps and closing the conjunctiva, so the total surgical time is significantly reduced. It is also easier and does not require much surgical expertise to use the 25-gauge forceps to grasp and exteriorize the haptic. Fibrin glue takes only 20 seconds to act in the scleral bed, and it helps in adhesion and hemostasis. Fibrin glue has been shown to provide airtight closure, and by the time the fibrin starts degrading, surgical adhesions would have already occurred in the scleral bed. The commercially available fibrin glue that we used is virus inactivated and is checked for viral antigen with polymerase chain reaction; hence, the chance of transmission of infection is low. But with tissue derivatives, there is always a theoretical possibility of transmission of viral infections; therefore, it is mandatory to get informed consent from the patient before the procedure. Although the use of fibrin glue in ophthalmology is considered off-label, it has been successfully used in the eye. Its various uses in the eye include repair of lacerated canaliculi to seal full thickness macular holes, cataract incisions, corneal perforations and traumatic lens capsule perforations. It has also been used for temporary closure of scleral flaps after trabeculectomy in eyes with hypotony, conjunctival fistula closure, conjunctival autografts and amniotic membrane transplantation.

Gabor et al have shown sutureless scleral IOL fixation by placing the IOL haptic in a scleral tunnel. Glued IOL technique differs from other sutureless methods by use of the fibrin glue, which enhances the rate of adhesion of scleral flaps with hemostasis. There is also no danger of intraocular infection gaining entry through the tunnel, as the fibrin glue hermetically seals the flaps, leaving behind no possible entry route for microbes. There is no glue-induced intraocular inflammation in any of the patients, and all eyes have clear media on the postoperative visits. Scleral indentation performed in the operated eyes showed no change in the axial positioning of the IOL. No IOL decentration or any other complication is seen in any of the operated eyes.

ADVANTAGES: The Glued IOL technique would be useful in a myriad of clinical situations where scleral fixated IOLs are indicated such as luxated IOL, dislocated IOL, zonulopathy or secondary IOL implantation.

NO SPECIAL IOL’S: It can be performed well with rigid 3 piece PMMA IOL or a 3 piece PC Foldable IOL. One therefore, does not need not to have an entire inventory of special Scleral Fixated IOLs with eyelets. In dislocated posterior chamber PMMA IOL, the same IOL can be repositioned thereby reducing the need for further manipulation. Furthermore, there is no need for newer haptic designs or special instruments other than the Glued IOL forceps.

NO TILT: Since the overall diameter of the routine IOL is about 12 to 13 mm, with the haptic being placed in its normal curved configuration and without any traction, there is no distortion or change in shape of the IOL optic. Externalization of the greater part of the haptics along its curvature stabilizes the axial positioning of the IOL and thereby prevents any IOL tilt. The two factors that contribute to the ability of IOL loops to maintain their original symmetrical configuration are loop rigidity — the resistance of the haptic to external forces that act to bend the loops centrally — and loop memory — the ability of the loops to re-expand laterally to their original size and configuration. Loop rigidity is seen as the centrifugal force vector of the haptics that resists compression by the capsular bag in an in-the-bag IOL. Loop memory is responsible for the gently stretched haptics following the globe curvature and creating a centripetal force that, along with the intralamellar scleral tuck, stabilizes the IOL. These two concepts can be understood by compressing or stretching the haptics in vitro. Another issue to be addressed is IOL centration and tilt. Using optical coherence tomography, we measured IOL centration with dilated pupil on retroillumination slit lamp photographs processed with Matlab version 7.1. IOL tilt was assessed using the anterior segment OCT and also by assessing the change in the third and fourth Purkinje images. Difference in the topographic (Orbscan) and manifest refraction was also found to be constant in all eyes during the entire postoperative period, which was suggestive of minimal new IOL-induced astigmatism. In our study, centration of the IOL was good with no detection of IOL tilt. Postoperative follow-up anterior segment OCT also showed perfect scleral flap adhesion as early as day 1, which continued at 1 week and 1 month. Two weeks’ continuous immersion of the IOL with haptics on stretch in a water bath with balanced salt solution maintained at body temperature did not show any change in measurements from pre- to post-immersion. Neither was there any change with drying after 2 weeks.

LESS PSEUDOPHACODONESIS: When the eye moves, it acquires kinetic energy from its muscles and attachments and the energy is dissipated to the internal fluids as it stops. Thus pseudophacodonesis is the result of oscillations of the fluids in the anterior and posterior segment of the eye. These oscillations, initiated by movement of the eye, result in shearing forces on the corneal endothelium as well as vitreous motion lead to permanent damage. Since the IOL haptic is stuck beneath the flap, it would prevent the further movement of the haptic and thereby reducing the pseudophacodonesis.

LESS UGH SYNDROME: We expect less incidence of UGH syndrome in fibrin glue assisted IOL implantation as compared to sutured scleral fixated IOL. This is because; in the former the IOL is well stabilized and stuck onto the scleral bed and thereby, has decreased intra-ocular mobility whereas in the latter, there is increased possibility of IOL movement or persistent rub over the ciliary body.

NO SUTURE RELATED COMPLICATIONS: Visually significant complications due to late subluxation which has been known to occur in sutured scleral fixated IOL may also be prevented as sutures are totally avoided in this technique. Another important advantage of this technique is the prevention of suture related complications like suture erosion, suture knot exposure or dislocation of IOL after suture disintegration or broken suture.

RAPIDITY AND EASE OF SURGERY: Since all the time taken in SFIOL for passing suture into the IOL haptic eyelets, to ensure good centeration before tying down the knots as well as time for suturing scleral flaps and closing conjunctiva are significantly reduced. The risk of retinal photic injury which is known to occur in SFIOL would also be reduced in our technique due to the short surgical time. Fibrin glue takes less time to act in the scleral bed and it helps in adhesion as well as hemostasis. The preparation time can also be reduced in elective procedures by preparing it prior to surgery as it remains stable upto 4 hours from the time of reconstitution. Fibrin glue has been shown to provide airtight closure and by the time the fibrin starts degrading, surgical adhesions would have already occurred in the scleral bed. This is well shown in the follow up anterior segment OCT where postoperative perfect scleral flap adhesion is observed.

STABILITY OF THE IOL HAPTIC: As the flaps are manually created, the rough apposing surfaces of the flap and bed heal rapidly and firmly around the haptic, being helped by the fibrin glue early on. The major uncertainty here is the stability of the fibrin matrix in vivo. Numerous animal studies have shown that the fibrin glue is still present at 4 – 6 weeks. Because post-operative fibrosis starts early, the flaps become stuck secondary to fibrosis even prior to full degradation of the glue.The ensuing fibrosis acts to form a firm scaffold around the haptic which prevents movement along the long axis(Figure 1) .The tucking the haptic tip into the scleral wall through a tunnel prevents all movement of the haptic along the transverse axis as well (Figure 2).The stability of the lens first comes through the tucking of the haptics in the scleral pocket created. Fig.1                                                         Fig.2

The tissue glue then gives it extra stability and also seals the flap down. Externalization of the greater part of the haptics along its curvature stabilises the axial positioning of the IOL and thereby prevents any IOL tilt.

GLUED Vs SUTURED SCLERAL- FIXATED IOL : Cadaver studies on glued IOL vs. sutured scleral-fixated IOL were done. Graded pressure was applied using first a mercury barometer and then known weights placed on both the IOLs. Glued IOL showed on par or better results as compared with the sutured scleral-fixated IOL. Although iridodonesis was seen as in many in-the-bag IOLs, there was a lack of pseudophakodonesis. The steady configuration of this IOL as compared with the sutured scleral-fixated IOL would result in less endophthalmodonesis and hence decreased complications such as postop retinal detachment or cystoid macular edema. IOL implantation in eyes that lack posterior capsular support has been accomplished in the past by using iris-fixated IOLs, anterior chamber IOLs and transscleral IOL fixation through the ciliary sulcus or pars plana. Surgical expertise, prolonged surgical time, suture-induced inflammation, suture degradation, and delayed IOL subluxation or dislocation due to broken suture are some of the limitations in sutured scleral-fixated IOL. It is also difficult and time-consuming, requiring minute and perfect adjustment of suture length and tension to ensure good centration of the scleral-fixated IOL. The other advantage of the glued IOL is that in case of intraoperative capsular loss, one does not need to have an entire inventory of special scleral-fixated IOLs with eyelets, unlike with sutured scleral-fixated IOLs.

SUMMARY : Fibrin glue-assisted sutureless posterior chamber IOL implantation is appropriate for eyes with deficient or absent posterior capsule, and this can be performed easily with the available IOL designs and instruments and with less surgical time. However, a longer duration follow-up might be necessary to judge the long-term functional and anatomical results of the procedure.

FOR MORE  INFORMATION: •	Amar Agarwal, MS, FRCS, FRCOphth is director of Dr. Agarwal’s Group of Eye Hospitals and Eye Research Centre. Prof. Agarwal is the author of several books published by SLACK, Incorporated, publisher of Ocular Surgery News, includingPhaco Nightmares: Conquering Cataract Catastrophes, Bimanual Phaco: Mastering the Phakonit/MICS Technique, Dry Eye: A Practical Guide to Ocular Surface Disorders and Stem Cell Surgery, and Presbyopia: A Surgical Textbook. He can be reached at 19 Cathedral Road, Chennai 600 086, India; fax: 91-44-28115871; e-mail: dragarwal@vsnl.com; Web site: www.dragarwal.com.

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