Glued endocapsular hemi-ring segment for fibrin glue–assisted sutureless transscleral fixation of the capsular bag in subluxated cataracts and intraocular lenses

TECHNIQUE

Glued endocapsular hemi-ring segment for fibrin glue–assisted sutureless transscleral fixation of the capsular bag in subluxated cataracts and intraocular lenses Soosan Jacob, MS, FRCS, DNB, Amar Agarwal, MS, FRCS, FRCO, Athiya Agarwal, MD, DO, Kaladevi Sathish, MS, Gaurav Prakash, MD, Dhivya Ashok Kumar, MD

Surgical expertise, prolonged surgical time, suture-related problems, and delayed intraocular lens (IOL) subluxation or dislocation due to broken sutures are limitations of suture fixation of the capsular bag to the scleral wall. We describe a new device made of IOL haptic material (polyvinylidene fluoride) that allows sutureless fibrin glue–assisted transscleral fixation of the capsular bag to address these issues. The device has a hemi-ring portion that lies in the capsular fornix and a double scroll mechanism that engages the capsulorhexis rim. The scroll extends forward as a haptic that is exteriorized through a sclerotomy under a lamellar scleral flap and tucked into a scleral tunnel. The flap is closed with fibrin glue. The device is used for subluxated cataracts and IOLs. It anchors the capsular bag to the sclera, giving vertical and horizontal stability, while providing fornix expansion and allowing stabilization of the bag intraoperatively and postoperatively. The device has been used in 4 patients who had good intraoperative and postoperative courses over a 5-week period. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. J Cataract Refract Surg 2012; 38:193–201 Q 2012 ASCRS and ESCRS Online Video

Subluxated cataracts are challenging from construction of the capsulorhexis to insertion of the intraocular lens (IOL).1,2 However, the greatest challenge is stabilization of the capsular bag during and after surgery. Surgical expertise, prolonged surgical time, suture-related problems, and delayed IOL subluxation or dislocation due to broken sutures are limitations of suture fixation of the capsular bag to the scleral wall. We describe a new device that allows sutureless fibrin glue–assisted transscleral fixation of the capsular bag, which stabilizes the bag intraoperatively and postoperatively. Submitted: August 30, 2011. Final revision submitted: September 27, 2011. Accepted: October 9, 2011. From Dr. Agarwal’s Eye Hospital and Eye Research Centre, Chennai, India. Corresponding author: Amar Agarwal, MS, FRCS, FRCO, Dr. Agarwal’s Eye Hospital and Eye Research Centre, 19, Cathedral Road, Chennai-600086, India. E-mail: [email protected]. Q 2012 ASCRS and ESCRS Published by Elsevier Inc.

The device (Epsilon Eye Instruments), designed by one of us (S.J.), is made of a single piece of polyvinylidene fluoride (PVDF) that has been wound into the desired configuration (Figure 1, A). The device has 2 arms that constitute the hemi-ring segment portion. One arm extends to the other side and then loops back in a double-loop fashion, close to the original arm, until it reaches the center of the ring segment. At this point, it winds into a 2.5 mm diameter safety pin loop–like double scrolled structure (Figure 1, B), which extends tangentially into a peripheral extension that is the haptic of the glued endocapsular hemi-ring segment. The arms are designed to sit within the fornix of the capsular bag; the scrolls engage the capsulorhexis margin, and the haptic anchors the entire bag transsclerally. The length from arm to arm is 14.0 mm, although the device can be manufactured in different lengths according to surgeon preference. SURGICAL TECHNIQUE The device can be used in patients with subluxated cataracts, colobomatous lenses, or subluxated IOLs. 0886-3350/$ - see front matter doi:10.1016/j.jcrs.2011.12.001

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Figure 1. A: The PVDF device winding into the double scrolled structure and then into a peripheral extension, which is the haptic of the glued endocapsular hemi-ring segment. B: The double scrolls of the device that engage the capsulorhexis rim in an atraumatic manner.

Exclusion criteria include patients with autoimmune or other rheumatological diseases. Surgical Technique for Subluxated Cataracts and Colobomatous Lenses The side of missing or weak zonular fibers is determined, and a partial-thickness scleral flap is made in this quadrant. Once the flap is created, the next few steps are as described for phacoemulsification in subluxated cataracts. Anterior vitrectomy is done if vitreous is prolapsing into the anterior chamber in the area of dialysis. The capsulorhexis is created in a manner comfortable to the surgeon, avoiding excessive traction on the zonules and using the microrhexis forceps as required (Figure 2 A). Hydrodissection and hydrodelineation are then performed gently to loosen the cortex and to delineate the nucleus, being careful not to churn up the cortex. A sclerotomy is made under the scleral flap with a 20-gauge needle about 1.5 mm from the limbus (Figure 2, B). The needle should emerge in the space between the iris and the anterior lens capsule. A cohesive ophthalmic viscosurgical device (OVD) may be injected under the iris to create space and to push the iris upward at the site of zonulodialysis to make this step easier. The haptic of the glued endocapsular hemi-ring segment (Figure 2, C) is inserted into the anterior chamber through the main port. The tip of the haptic is introduced into the jaws of a waiting microforceps that has been introduced through the sclerotomy. Any microforceps with serrated (preferred)/plain jaws that can pass through the 20-gauge sclerotomy can be used. Using a similar forceps inserted through the side port and the handshake technique, the haptic is transferred between the 2 hands (Figure 2, D) until the surgeon is holding the haptic at its extreme tip with the forceps passed under the scleral flap (Figure 2, E). The haptic is exteriorized while, at the same time, the rest of the ring segment is held at the double scrolls and flexed into the anterior chamber

using the other hand. Since the glued endocapsular hemi-ring is made of flexible material, it can be easily pushed in through the main port by holding it at the scrolls and fishtailing it in a 1-handed technique (Figure 2, F). Once inside the anterior chamber, the hemi-ring segment opens. The 2 arms of the ring segment are then inserted under the capsulorhexis (Figure 3, A). The circular scrolls are caught by the microforceps and maneuvered so the capsulorhexis margin slips into the plane between 2 circular loops of the scrolls (Figure 3, B). Once the capsulorhexis margin is engaged by the scrolls, pulling on the exteriorized haptic pulls the entire capsular bag complex and centers it (Figure 3, C). The haptic is cut (Figure 3, D), ensuring that a sufficient length is retained to tuck into a scleral tunnel (Figure 3, E) made with a 26-gauge needle at the edge of the scleral flap, curving toward the limbus. The tangentially oriented haptic is tucked into the scleral tunnel to hook it to the scleral wall (Figure 3, F). It winds around the eye intrasclerally, hugging the eye wall, and retains the entire capsular bag complex in its centered position. Phacoemulsification is performed as usual, followed by epinucleus and cortex aspiration. The IOL is finally implanted in the bag. Further centering of the bag, if desired, is done by adjusting the degree of tuck of the haptic into the scleral tunnel. The scleral flap, as well as the conjunctiva, is closed with fibrin glue (Reliseal, Reliance Life Sciences or Tisseel, Baxter) (Video, available at http://jcrsjournal.org). RESULTS This technique was used as described in 4 patients with varying degrees of cataractous lens subluxation (Table 1, Figure 4 A to I). The glued endocapsular hemi-ring segment was easy to insert and provided adequate capsule support in all patients. The IOL was implanted in the bag. The mean Snellen corrected distance visual acuity (CDVA) was 0.395 (decimal

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Figure 2. A: A 180-degree subluxation is seen. A scleral flap has been created inferiorly and a capsulorhexis is being created. B: A sclerotomy is made under the scleral flap with a 20-gauge needle, which emerges in the space between the iris and the anterior lens capsule. C: Glued endocapsular hemi-ring segment to be inserted in the orientation shown. D: The haptic of the glued endocapsular hemi-ring segment is caught by a microforceps introduced from the side port and transferred into the jaws of a waiting end-gripping microforceps introduced through the sclerotomy. E: Using the handshake technique, the haptic is transferred between the surgeon’s 2 hands. F: The haptic is exteriorized while the rest of the ring segment is fishtailed into the anterior chamber using the other hand.

equivalent) preoperatively and 0.582 on day 1 postoperatively. At 1 week and 5 weeks, the mean CDVA was 0.825 and 0.868, respectively. All the patients had a CDVA of more than 0.67 at 5 weeks. The visual acuity was stable from the 1-week to 5-week period and the IOL remained centered during the 5-week follow-up in all patients. One eye had grade 2 cells and flare, which subsided by the third postoperative day with topical corticosteroids. All eyes were quiet without cells or flare at 5 weeks. There was no significant change in the mean intraocular pressure. No major anterior or posterior segment complications were encountered during the follow-up (Figures 5 and 6). Technique for Subluxated in-the-Bag Intraocular Lens Space is created in the bag with OVD–assisted dissection and the glued endocapsular hemi-ring segment is implanted in the bag in a manner similar to that described previously. The haptic is tucked in the scleral tunnel, and the degree of tuck is adjusted until good centration of the IOL–capsular bag complex is attained. The scleral flap and conjunctiva are then glued down using fibrin glue.

DISCUSSION Subluxated cataracts have been a surgical challenge. Surgeons around the world have worked to overcome hurdles associated with surgery and successful implantation of IOLs and to obtain better results in these cases. The endocapsular ring was first described by Hara et al. in 1991.3 Nagamoto4 and BissenMiyajima5 almost simultaneously used an open poly(methyl methacrylate) (PMMA) ring model for better adaptability to the capsular bag. Legler et al.A further popularized its use. Since then, various modifications have been proposed. The Henderson and Kim6 capsular tension ring has 8 equally spaced indentations, which makes cortical removal easier. The square truncated edge rings described by Nishi et al.7 and the foldable closed capsular bending ring described by Dick8 reduce anterior capsule fibrosis as well as posterior capsule opacification. These rings do not have an element for scleral fixation and hence cannot be used in dialysis of more than 3 to 4 clock hours. To overcome this problem, Cionni and Osher9 introduced the modified capsular tension ring, the Cionni ring, which has a hook that allows suture fixation of

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Figure 3. A: The 2 arms of the ring segment are inserted under the capsulorhexis using a forceps. B: The circular scrolls are caught by the microforceps and maneuvered to engage the capsulorhexis margin in the plane between 2 circular loops of the scrolls. C: After the capsulorhexis rim is engaged by the scrolls, pulling on the exteriorized haptic pulls the entire capsular bag complex and centers it. D: The haptic is cut, retaining a sufficient length. E: A 26-gauge needle is used to create a scleral tunnel at the edge of the scleral flap. F: The tangentially oriented haptic is tucked into the scleral tunnel.

the endocapsular ring to the scleral wall, making safe phacoemulsification and in-the-bag IOL implantation in eyes with subluxation of greater than 3 to 4 clock hours possible. Microhooks in the form of iris retractors10,11 and capsule stabilization devices such as the Mackool capsular retractor12,13 or the device described by Nishimura et al.14 were proposed for capsular bag stabilization during cataract surgery to avoid stress on the remaining zonular apparatus during the steps of phacoemulsification. Capsular tension segments such as the Ike segments15,B and the Assia anchors16 can be inserted at any time during surgery for intraoperative support and are sutured onto the scleral wall with 9-0 or 10-0 polypropylene (Prolene) sutures for intraoperative and postoperative support and centration of the capsular bag. Yaguchi et al.17 have described

T-shaped capsule stabilization hooks, which have a 3.75 mm footpad that engages the capsule and are sutured to the sclera. The hooks are attached to a curved needle. Lens removal and secondary IOL implantation has also been described for subluxated cataracts.18,19 In 2007, we described the glued IOL technique for posterior chamber IOL (PC IOL) fixation in eyes with insufficient capsule support.20 We subsequently used it with good results in subluxated cataracts, in which we perform a primary lensectomy/lens extraction and glued IOL implantation.21 The glued endocapsular hemi-ring segment was designed using PVDF of about 130 mm diameter. This is the same material and gauge used for manufacturing IOL haptics and hence has a long and

Table 1. Patient characteristics. Patient 1 2 3 4

Age (Y)

Sex

Cause of Subluxation

Degree of Zonulodialysis (Degree)

Follow-up (Wk)

55 50 45 60

Female Male Male Male

Trauma with hand Trauma with shuttle cock Marfan syndrome Trauma with stick

180 inferior 180 inferior 180 inferonasal 180 superonasal

7 6 6 5

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Figure 4. A: The design of the glued endocapsular hemi-ring is seen as well as its positioning in the direction of dialysis. B: A lamellar scleral flap and sclerotomy are created in the area of dialysis. The haptic of the device is introduced into the anterior chamber. C: The haptic is caught by an end-gripping microforceps introduced through the sclerotomy. D: The rest of the glued endocapsular hemi-ring is flexed in using a singlehanded fish-tailing technique. E: The circular scrolls engage the capsulorhexis rim. F: The capsular bag is centered. G: A scleral tunnel is created at the edge of the scleral flap with a 26-gauge needle. H: The haptic is tucked into the tunnel. I: Fibrin glue is applied and the flap is sealed down over the haptic.

safe history of biocompatibility within the eye. Polyvinylidene fluoride was chosen because it is known to have better shape recovering capability and better memory than other IOL haptic materials, especially polypropylene.22,23 Our experience with the glued

IOL over the past 4 years,20,21 as well as that reported by Scharioth et al.,24,25 shows that this material is biocompatible within the scleral wall and remains in place without significant long-term issues. The flexibility of the material allows it to be inserted through the

Figure 5. A: At 1 day, the IOL is well centered, the cornea clear, and the eye quiet. B: At 1 month, the IOL remains well centered and the eye is quiet. The terminal loop of the device is seen near the margin of the fully dilated pupil. It is lying inert and causing no reaction.

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Figure 6. A: Case 3, 3 months postoperatively. The IOL is well centered, and the eye is quiet. Superior iris chafing that occurred during phacoemulsification is seen. B: Case 4, 1 month postoperatively. The eye is quiet, the pupil round, and the IOL well centered. The scleral flap can be seen superiorly in the area of dialysis.

main port in a single-handed manner, unlike the 2-handed fishtailing technique for the PMMA ring. The fishtail technique, described by Angunawela and Little26 also decreases shearing and tractional forces on the zonules as well as the chance of tearing the capsule. At the same time, the ring segment does not have the potential disadvantage of cracking while being inserted that a PMMA endocapsular ring might have. There is also no need for extension of the incision as the ring segment easily flexes on itself. Once the 2 arms are in the fornix, the double scrolls of the device engage the capsulorhexis rim in an atraumatic manner, similar to the manner in which the single scroll of the polypropylene structure of the Malyugin ring27 (MicroSurgical Technology) engages the pupillary border for pupil expansion.C The anterior capsule rim around the capsulorhexis should be adequate to engage the double scroll locking mechanism. A capsulorhexis that is too small or one that extends up to the equator should therefore be avoided. The hemi-ring segment is flexible and has an opensegment design. It may be suitable for smaller as well as bigger capsular bags, although further studies are required to corroborate its use as a one-size-fits-all solution. We recommend caution in its use in very small eyes, such as pediatric and microspherophakic eyes, until further studies are carried out. If the pupil is constricted during surgery, it might be advisable to insert iris hooks to allow steps from capsulorhexis construction to glued endocapsular hemi-ring segment insertion to phacoemulsification and IOL implantation to be carried out easily and with good visualization. In the presence of vitreous prolapsing around the subluxation, an anterior vitrectomy should be performed at the start of the procedure to prevent traction on vitreous strands. The haptic of the glued endocapsular hemi-ring segment is manufactured tangential to the scroll and is easy to grasp using the handshake technique.D It is turned and tucked into an intrascleral tunnel as in a glued IOL technique.20,21 This prevents the ring

segment from moving within the tight tunnel created by the 26-gauge needle (Figure 7). Once the tip is tucked into the scleral tunnel, it stabilizes the entire capsular bag intraoperatively as well as postoperatively by anchoring the bag transsclerally, as with a glued IOL.20,21 We called the device a hemi-ring segment because with an overall diameter of about 14.0 mm and an arc length of 180 degrees, it extends 6 clock hours and occupies 2 quadrants of the capsular bag. Therefore, despite not extending around the entire circumference of the bag, it provides centrifugal equatorial expansion of the capsular bag in the area of zonulodialysis. It also redistributes stress to an extent from the intact zonules to the areas of absent zonules, depending on the extent of zonulodialysis. It therefore provides horizontal and vertical stability and decreases the flaccidity of the posterior capsule even though it is a segment and not a complete ring. By being longer than endocapsular segments, it is likely

Figure 7. The tangentially oriented haptic of the glued endocapsular hemi-ring segment is turned and inserted into a scleral tunnel, preventing it from moving within the tight tunnel created by the 26-gauge needle.

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to provide better expansion of the fornix and decrease chances of fornix–capsular bag aspiration into the phaco tip while also decreasing the chances of vitreous prolapse through the area of dialysis. Endocapsular rings have been reported to drop into the vitreous either intraoperatively or postoperatively28–30 and often require pars plana vitrectomy for its removal. As the haptic of the glued endocapsular hemi-ring segment is externalized via the sclerotomy at the very beginning of the procedure, the chances of the segment dropping into the vitreous intraoperatively through an area of a large zonular defect are less likely, and therefore no preplaced sutures are required. Also, as the haptic is anchored in the sclera along its length, the chances of a postoperative drop of the endocapsular ring into the vitreous are also less. The other advantage that the glued endocapsular hemi-ring segment has over sutured scleral fixation is the ease and rapidity of surgery. Overall surgical time is reduced as exteriorizing the segment is easy and fast and does not involve the use of thin, difficult to maneuver needles (as with 10-0 or 9-0 polypropylene or 8-0 polytetrafluoroethylene [Gore-Tex]), which are technically more challenging. A larger gauge also allows more sturdy and robust fixation of the capsular bag to the scleral wall. The current use of 9-0 polypropylene and 8-0 polytetrafluoroethylene sutures have been shown to have smaller breakage rates, although their use has not been studied as long. These would have to be compared with the glued endocapsular hemi-ring on a long-term basis to determine the advantages and disadvantages of each. In our experience, the glued endocapsular hemi-ring segment also gave greater stability to the bag intraoperatively for all the maneuvers that are required for phaco compared with sutured scleral fixation. Faster surgery is also likely to decrease the chances of developing retinal photic injury from prolonged exposure to microscope light. The glued endocapsular hemi-ring segment expands the capsular fornix as well as centers the bag by engaging the capsulorhexis, pulling the capsular bag toward the side of subluxation. The capsulorhexis is ovalized toward the direction of pull. Tucking the haptic should be done only to the desired extent of centration of the bag to avoid over pulling and affecting the zonules on the other side. Intraoperatively, the amount of centration of the capsular bag can be easily and rapidly adjusted at any stage of surgery by simply adjusting the tuck of the haptic. This is unlike sutured scleral fixation where final centration depends on the tautness of the suture and once the suture is tied down, readjusting centration of the capsular bag is more complicated and takes more time and effort by the surgeon. We also feel that

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compared with sutured scleral fixation, it might give more rotational stability to the bag and less pseudophakodonesis as it is an extension of the intracapsular segment that carries out through the scleral wall and there is a tight intrascleral tuck of a significant length of this externalized haptic. This is unlike the sutured rings that are suspended from the scleral wall by means of sutures. This is analogous to the greater amount of pseudophakodonesis seen in a sutured scleral fixated IOL than with a glued IOL. The glued endocapsular hemi-ring also has an advantage over sutured rings and segments in its mode of transscleral fixation. With the glued endocapsular hemi-ring segment, similar to the glued IOL, it is the intrascleral tuck of the haptic that fixates the capsular bag. Therefore, all postoperative suture-related complications that are associated with sutured endocapsular rings such as knot exposure, suture erosion, suture degradation resulting in late subluxation, and dislocation are eliminated. There have been various reports postulating long-term instability of 10-0 polypropylene sutures within the eye when used for scleral fixation of a PC IOL.31–35 Localized degradation and cracking of sutures are reported by Price et al.35 on microscopic evaluation of suture remnants found on dislocated sutured scleral-fixated IOLs. This might be especially significant in pediatric eyes, in which long-term fixation is particularly important.36,37 The scleral flap is sealed with fibrin glue over the haptic. This creates a hermetic seal around the haptic that prevents egress from or ingress into the eye. Surgical fibrosis develops early under the flap and around the haptic, sealing the flap into place to ensure flap adhesion even when fibrin glue has degraded. We have been using glue to seal the scleral flap over the haptic of glued IOLs since 2007 and have found it safe and effective.20,21 The commercially available fibrin glue is virus inactivated and is checked for viral antigen and antibodies with polymerase chain reaction; hence, chances of infection transmission are low. Other techniques for closing the flap such as multiple sutures on the flap may be used along with a Siedel test to check for leakage, but we personally recommend the use of fibrin glue and believe that when fibrin glue is used to seal the flap, it seals the sclerotomy hermetically. If the surgeon wants to explant the glued endocapsular hemi-ring segment for any reason during surgery, this can be done relatively simply. The haptic is released from the scleral tunnel and is pushed inward gently so it comes to lie within the anterior chamber. It may simultaneously also be pulled inward with a microforceps passed through a paracentesis. Under cover of an OVD, the scrolls are then grasped with an end-gripping microforceps

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Figure 8. A: The glued endocapsular hemi-ring segment is easy to remove by grasping the scrolls with an end-gripping microforceps introduced through the main port. B: It is then pulled toward the incision after releasing the tucked haptic. C: The entire segment flexes out through the main port without chances of dropping, breaking, or having to extend the incision. D: The segment is brought out completely. The procedure is done under a dispersive OVD.

introduced through the main port and pulled toward the incision. The entire segment flexes out through the main port, and there is no need for extension of the wound (Figure 8, A to D). In conclusion, the glued endocapsular hemi-ring segment is a new device to stabilize the capsular bag intraoperatively and postoperatively and allows sutureless fibrin glue-assisted transscleral fixation of the capsular bag. It has been designed to eliminate issues associated with suture fixation of capsular tension rings. It anchors the bag to the scleral wall, providing vertical and horizontal stability while also providing fornix expansion. Our initial intraoperative and postoperative results are promising. Further studies including more patients and with longer follow-up are required to assess the long-term safety and stability. REFERENCES 1. Santoro S, Sannace C, Cascella MC, Lavermicocca N. Subluxated lens: phacoemulsification with iris hooks. J Cataract Refract Surg 2003; 29:2269–2273 2. Jacob S, Agarwal A, Agarwal A, Agarwal S, Patel N, Lal V. Efficacy of a capsular tension ring for phacoemulsification in eyes with zonular dialysis. J Cataract Refract Surg 2003; 29:315–321 3. Hara T, Hara T, Yamada Y. “Equator ring” for maintenance of the completely circular contour of the capsular bag equator after cataract removal. Ophthalmic Surg 1991; 22: 358–359 4. Nagamoto T. Origin of the capsular tension ring [letter]. J Cataract Refract Surg 2001; 27:1710–1711

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J CATARACT REFRACT SURG - VOL 38, FEBRUARY 2012

First author: Soosan Jacob, MS, FRCS, DNB Dr. Agarwal’s Eye Hospital and Eye Research Centre, Chennai, India