Intrascleral fibrin glue intraocular lens fixation combined with Descemet-stripping automated endothelial keratoplasty or penetrating keratoplasty

Intrascleral fibrin glue intraocular lens fixation combined with Descemet-stripping automated endothelial keratoplasty or penetrating keratoplasty

ARTICLE Intrascleral fibrin glue intraocular lens fixation combined with Descemet-stripping automated endothelial keratoplasty or penetrating keratop...

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ARTICLE

Intrascleral fibrin glue intraocular lens fixation combined with Descemet-stripping automated endothelial keratoplasty or penetrating keratoplasty Rajesh Sinha, MD, FRCS, Himanshu Shekhar, MD, Namrata Sharma, MD, Radhika Tandon, MD, FRCSEd, FRCOphth, Jeewan S. Titiyal, MD, Rasik B. Vajpayee, MS, FRCSEd, FRANZCO

PURPOSE: To evaluate the outcomes of intrascleral haptic fixation of an intraocular lens (IOL) with fibrin glue combined with penetrating keratoplasty (PKP) or Descemet-stripping automated endothelial keratoplasty (DSAEK) for aphakic or pseudophakic bullous keratopathy (BKP). SETTING: Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. DESIGN: Case series. METHODS: Eyes with BKP had combined PKP or DSAEK with fibrin glue-assisted intrascleral posterior chamber (PC) IOL fixation; PKP was performed in eyes with a corneal scar and DSAEK in eyes without a scar. The parameters evaluated were corrected distance visual acuity (CDVA), anterior segment biomicroscopy, intraocular pressure, central corneal thickness (CCT), and IOL status. Intraoperative events and postoperative complications were recorded. RESULTS: The study evaluated 11 patients (11 eyes). Intrascleral fixation of a PC IOL with PKP or DSAEK was successfully performed in all eyes; PKP was performed in 6 eyes (54.54%) and DSAEK in 5 eyes. The mean CDVA improved from 1.95 logMAR G 0.29 (SD) to 0.40 G 0.16 logMAR (P<.001). The mean CCT was 0.741 G 0.71 mm preoperatively and 0.579 G 0.20 mm postoperatively (P<.001). There were no cases of intraoperative or postoperative IOL decentration or other complications. CONCLUSIONS: Fibrin glue-assisted intrascleral fixation of a PC IOL combined with DSAEK or PKP was a safe, effective method to manage BKP with aphakia or malpositioned IOLs. The IOL fixation was strong enough to sustain the manipulation required for corneal procedures. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. J Cataract Refract Surg 2012; 38:1240–1245 Q 2012 ASCRS and ESCRS

Bullous keratopathy (BKP) is a major complication of cataract surgery. In most cases, penetrating keratoplasty (PKP) or Descemet-stripping automated endothelial keratoplasty (DSAEK) are effective surgical modalities for treating the condition.1–3 Some cases may require implantation or exchange of the intraocular lens (IOL). Intraocular lens exchange is recommended in cases with closed-loop IOLs, semiflexible anterior chamber IOLs (AC IOLs), iris-supported IOLs, or unstable IOLs because these IOLs have been increasingly associated with poor macular function 1240

Q 2012 ASCRS and ESCRS Published by Elsevier Inc.

postoperatively. Balazs et al.3 recommend that the IOL be retained if its position is adequate and the pupil is mobile. In patients with recurrent hemorrhages, uncontrolled glaucoma, or chronic iritis resistant to medical treatment, the IOL should be removed. Current techniques for IOL exchange during keratoplasty, especially in cases with a deficient posterior capsule, are less than satisfactory. Transsclerally sutured IOLs have been described in these situations.4,5 However, the technique is associated with a longer learning curve, prolonged intraoperative 0886-3350/$ - see front matter doi:10.1016/j.jcrs.2012.02.042

INTRASCLERAL GLUED IOL WITH CORNEAL PROCEDURES

manipulation, postoperative pseudophacodonesis, and risk for postoperative decentration resulting from suture degradation or knot slippage.6–12 To overcome these problems, a new technique of fibrin glue– assisted sutureless fixation of posterior chamber IOLs (PC IOL) in eyes with deficient posterior capsule support has been described.13 In this study, we evaluated the technique and outcomes of intrascleral fixation of IOLs with fibrin glue combined with corneal transplantation (ie, PKP or DSAEK) for the treatment of endothelial decompensation. PATIENTS AND METHODS This retrospective study analyzed data of consecutive patients who had PKP or DSAEK combined with intrascleral fixation of PC IOLs with fibrin glue for postsurgical endothelial decompensation. The study was performed at a tertiary care ophthalmic hospital. The original surgery was performed elsewhere in all cases. The institute's ethics committee approved the study, and all patients provided informed written consent.

Patient Evaluation A detailed examination was performed in all eyes. The assessment included uncorrected distance visual acuity; corrected distance visual acuity (CDVA); slitlamp biomicroscopy of the anterior segment; intraocular pressure (IOP); central corneal thickness (CCT); IOL status; fundus evaluation, if possible; and ultrasonography to rule out posterior segment pathology. Intraoperative events were recorded and evaluated. In the postoperative period, the patients were evaluated for similar parameters as well as for the presence of complications.

Surgical Technique The same surgeon (R.S.) performed all surgeries using peribulbar anesthesia of 5 mL lignocaine hydrochloride 2.0% and 5 mL bupivacaine hydrochloride 0.5% for both techniques. The corneal procedure performed was based on the presence of corneal scarring; PKP was performed in eyes with a corneal scar and DSAEK in eyes without a scar.

Descemet-Stripping Automated Endothelial Keratoplasty with Glued Intraocular Lens The donor corneoscleral tissue was mounted on an artificial anterior chamber (Moria ALTK, Moria). A 350 mm head was chosen for the microSubmitted: November 6, 2011. Final revision submitted: February 12, 2012. Accepted: February 14, 2012. From the Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Corresponding author: Rajesh Sinha, MD, FRCS, S-7, Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. E-mail: [email protected].

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keratome (Moria). The lamellar dissection was performed with the microkeratome. The posterior lamella with the corneoscleral rim was placed on a polytetrafluoroethylene (Teflon) block with the endothelial side up, and an 8.0 mm donor lenticule was fashioned using a circular cutting trephine. A temporal approach was used in all the cases. A 20-gauge infusion cannula was placed via a sclerotomy in the inferotemporal area after a limited conjunctival peritomy was performed. A localized peritomy was made near the superior (12 o'clock) and inferior limbus (6 o'clock). The sclera was marked 1.5 mm and 3.0 mm from the limbus. Two partial-thickness radial scleral incisions were created parallel to each other between 1.5 mm and 3.0 mm from the limbus. A crescent blade was used to perform the lamellar dissection between the 2 incisions. The lamellar dissection was extended beyond the radial incisions on the temporal aspect on 1 side and on the nasal aspect on the other side. Partial-thickness scleral flaps were raised by cutting the roof of the tunnel at the fornix side to create a limbusbased scleral flap (Figure 1). A 20-gauge microvitreoretinal blade (Alcon Laboratories, Inc.) was used to create 2 sclerotomies, 1 each in the bed of the flap, 1.5 mm from the limbus. The center of the cornea was marked with an 8.00 mm circular cutting disposable corneal trephine. A temporal limbal tunnel was made with a 2.75 mm keratome. A paracentesis was created at the limbus adjacent to the corneal incision. Trypan blue dye was injected into the anterior chamber to stain Descemet membrane. Descemet membrane and the endothelium were scored with a reverse Sinskey hook following the superficial 8.00 mm mark on the cornea, and the membrane was removed. A limited anterior vitrectomy was performed to clear vitreous strands. The limbal tunnel was enlarged to 6.0 mm. A multipiece PC IOL was introduced into the anterior chamber with a McPherson forceps. The haptic was then guided into the bent tip of a vitreoretinal forceps introduced through the superior sclerotomy site. The haptic was externalized through the sclerotomy site under the superior scleral flap (Figure 2). The second haptic was managed similarly, externalized with the help of a vitreoretinal forceps inserted through the inferior sclerotomy and guided into the scleral pocket dissected nasally adjacent to the scleral flap. The superior tip of the haptic was then guided into the dissected scleral pocket. A drop of an ophthalmic viscosurgical device was placed on the endothelial side, and the donor lenticule was folded in a 40/60 fashion. It was held gently with a noncrushing forceps and inserted into the anterior chamber (Figure 3). The donor lenticule was unfolded and brought into position by gently stroking the cornea. The corneal tunnel was closed with a single 10-0 monofilament nylon suture. Air was injected to fill the anterior chamber and achieve tamponade for 10 minutes. The reconstituted fibrin glue (Baxter AG) was then injected into the pockets and over the beds of the scleral flap. The scleral flap was replaced and gentle pressure applied locally over the flap for 20 to 30 seconds to promote adherence of the glue to the scleral flaps. The irrigation cannula was removed and the port closed with a 6-0 polyglactin suture. The conjunctival flaps were closed by sticking them to the sclera with the application of fibrin glue. At the end of 10 minutes, 50% of the air in the chamber was exchanged with saline.

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INTRASCLERAL GLUED IOL WITH CORNEAL PROCEDURES

Figure 1. Lamellar scleral flap.

Figure 2. Haptic being externalized through the superior sclerotomy.

Postoperatively, the patient was asked to remain in a strict supine position with the face toward the ceiling for 8 to 10 hours. Topical moxifloxacin 0.5% 3 times a day, prednisolone acetate 1.0% eyedrops 4 times a day, tropicamide 1.0% eyedrops 2 times a day, and preservative-free lubricating drops 6 times a day were given postoperatively and subsequently tapered.

tucked into the scleral pocket dissected on both sides. The graft was placed, and 10-0 monofilament nylon interrupted cardinal sutures were applied. Similarly, the other 12 sutures were applied to appose the graft–host junction. The reconstituted fibrin glue was injected through the cannula of the double-syringe delivery system under the superior and inferior scleral flaps (Figure 4). Local pressure was applied over the flaps for 30 seconds to allow adhesion of the flap to the bed. The conjunctiva was also apposed with the glue. Postoperatively, topical moxifloxacin 0.5% 3 times a day, prednisolone acetate 1.0% eyedrops 4 times a day, tropicamide 1.0% eyedrops 2 times a day, and preservative-free lubricating drops 6 times a day were prescribed and subsequently tapered.

Penetrating Keratoplasty with Glued Intraocular Lens

The donor tissue was prepared using a manual trephine from a freshly prepared corneoscleral button by punching on a polytetrafluoroethylene block. The scleral flaps and the adjacent groove were created in a fashion similar to that for DSAEK. The host cornea was trephined using a 7.2 mm circular cutting disposable trephine. A multipiece PC IOL was held with a McPherson forceps at the pupillary plane with 1 hand and then externalized through the sclerotomy on 1 side and then the other side with a vitreoretinal forceps inserted through sclerotomy sites, as described earlier. The tips of the haptics were

Figure 3. Donor lenticule being inserted into the anterior chamber with a vitreoretinal forceps.

RESULTS The study comprised 11 patients (11 eyes). The mean age of the 7 men (63.63%) and 4 women (36.36%)

Figure 4. Fibrin glue being applied on scleral bed after securing donor tissue in PKP with 16 10-0 monofilament nylon interrupted sutures.

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INTRASCLERAL GLUED IOL WITH CORNEAL PROCEDURES

was 64 years (range 54 to 78 years). Table 1 shows the patient characteristics and surgical outcomes. Intrascleral fixation of a PC IOL with fibrin glue combined with PKP or DSAEK was successfully performed in all eyes. Penetrating keratoplasty was performed in 6 eyes (54.54%). Of these, 1 eye had an AC IOL, 1 had a PC IOL in the anterior chamber, and 2 had a decentered PC IOL that required explantation. Descemet-stripping automated endothelial keratoplasty was performed in 5 eyes, all of which were aphakic except 1. In the latter case, a decentered PC IOL was present and required explantation. The mean CDVA improved significantly, from 1.95 logMAR G 0.29 (SD) (range 1.3 to 2.3 logMAR) preoperatively to 0.40 G 0.16 logMAR (range 0.18 to 0.48 logMAR) postoperatively (P!.001). The mean CCT was 0.741 G 0.71 mm (range 0.633 to 0.991 mm) and 0.579 G 0.20 mm (range 0.546 to 0.612 mm), respectively (P!.001). By the 6-month follow-up, all 11 patients had maintained the 3-month CDVA, all grafts were clear, and all IOLs were well centered (Figures 5 and 6). There were no keratoplasty-related problems (infection, rejection, dehiscence) or IOL-related complications (vitreous incarceration, endophthalmitis, subluxation, haptic extrusion). There were no cases of intraoperative or postoperative IOL decentration.

surgical options for endothelial decompensation have changed significantly. At present, DSAEK is the procedure of choice to manage endothelial diseases such as Fuchs endothelial dystrophy, PBK, and endothelial graft failure. The advantages of DSAEK over PKP include faster visual recovery, relative refractive neutrality, increased intraoperative safety, and a smaller incision (5.0 mm), which leaves the eye stronger and less prone to traumatic rupture.18,19 However, in the presence of a dense corneal scar, PKP is the only surgical option because the visual axis clarity is inadequate for DSAEK. In our series, 6 of 11 patients had PKP because of deep corneal scarring. In cases of PBK, the IOL is not appropriately placed in some cases and may require removal, replacement, or repositioning. Intraocular lens exchange is recommended in cases with closed-loop IOLs, semiflexible AC IOLs, iris-supported IOLs, or unstable IOLs because these IOLs have been increasingly associated with endothelial compromise and poor macular function postoperatively. In our series, all cases required IOL explantation because the IOLs were decentered or malpositioned or were AC IOLs that were touching or were very close to the endothelium, causing its decompensation. Brunette et al.20 found that implanting a PC IOL at the time of PKP provides better results than implanting an AC IOL; graft survival is longer, the IOP is lower, and the postoperative visual outcomes are better, even when the posterior capsule is damaged. Because all cases in our series had compromised capsule support, intrascleral haptic fixation of a PC IOL assisted with fibrin glue was a viable option.

DISCUSSION At the end of the 1990s, pseudophakic bullous keratopathy (PBK) was the most important indication for PKP14–17 because of the high rate of AC IOL implantation in the 1980s. In the past few years, the

Table 1. Patient details and surgical outcomes. Preoperative

Postoperative

Pt

Age (Y)

Sex

Indication

Corneal Surgery

CDVA (LogMAR)

CCT (mm)

IOP (mm Hg)

CDVA (LogMAR)

CCT (mm)

IOP (mm Hg)

Explanted IOL

1 2 3 4 5 6 7 8 9 10 11

62 54 74 66 56 60 64 63 59 70 78

F M M M F M M M M F F

ABK ABK PBK ABK ABK PBK ABK PBK ABK PBK PBK

DSAEK DSAEK PKP PKP DSAEK DSAEK PKP PKP DSAEK PKP PKP

2.00 1.78 2.30 2.30 1.78 2.00 2.00 1.78 1.30 2.30 2.00

820 788 642 633 792 832 712 697 763 678 798

18 16 19 18 20 14 17 16 14 16 12

0.60 0.48 0.30 0.30 0.18 0.60 0.60 0.48 0.18 0.30 0.48

585 562 573 612 598 605 589 564 578 546 560

14 12 16 16 18 14 16 18 12 12 14

None None AC IOL None None PC IOL None PC IOL None PC IOL PC IOL

ABK Z aphakic bullous keratopathy; AC IOL Z anterior chamber intraocular lens; CCT Z central corneal thickness; CDVA Z corrected distance visual acuity; DSAEK Z Descemet-stripping automated endothelial keratoplasty; IOL Z intraocular lens; IOP Z intraocular pressure; PBK Z pseudophakic bullous keratopathy; PC IOL Z posterior chamber intraocular lens; PKP Z penetrating keratoplasty; Pt Z patient

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INTRASCLERAL GLUED IOL WITH CORNEAL PROCEDURES

Figure 5. Clear cornea with intrasclerally fixated IOL 6 months after DSAEK.

Figure 6. Clear graft with intrasclerally fixated IOL 6 months after PKP.

Furthermore, in cases of aphakia, there is a risk for posterior migration of injected air and dislocation of the lenticule into the vitreous cavity.21 Placement of an IOL before the donor lenticule will not only improve the air tamponade but also reduce the risk for donor lenticule dislocation. Scleral fixation of a PC IOL combined with DSAEK has been successfully performed.22 The safety and long-term efficacy of a transsclerally sutured PC IOL are less than satisfactory.7,8,23 In addition to problems related to accurate suturing at the ciliary sulcus, there are issues with IOL–iris contact, pigment dispersion, high aqueous flare, and vitreous incarceration. Sutureless positioning of standard 3-piece PC IOLs by fixating the haptics in a limbus-parallel scleral tunnel has been reported in eyes without capsule support.24 Gabor and Pavlidis24 used a technique in which a sclerotomy is made in full-thickness sclera and the haptics are externalized and then introduced into a scleral tunnel created with a needle. In our study, we created a partial-thickness scleral flap and the sclerotomy was made in the scleral bed. This sclerotomy was covered by replacing the scleral flap back and sticking it with fibrin glue. Thus, there was no risk for the creation of a communication track from outside to inside the eye, theoretically reducing the risk for infectious organisms gaining access into the eye. Use of fibrin glue completely blocks the sclerotomy, reducing the risk for hypotony and infection. However, use of fibrin glue increases the cost of the procedure. Intrascleral glue fixation of a PC IOL combined with DSAEK has potential benefits over use of an AC IOL because it does not reduce the anterior chamber volume, does not require intact iris tissue, and unlike suture-fixated IOLs, does not carry the risk for knot

slippage or pseudophakodonesis.25 No patient in our series had a significant complication, and all maintained a stable CDVA of approximately 20/40. In PKP, intrascleral fixation of IOL with fibrin glue can also be a safe and effective alternative. This technique reduces the surgical time25,26 and the time required for IOL fixation in an open globe after host trephination. The only additional time required is for externalizing and tucking the haptic; this reduces the risk for expulsive hemorrhage or choroidal effusion. No intraoperative complication occurred in eyes having PKP with IOL fixation. Another aim of our study was to determine whether intrascleral fixation of an IOL by this technique is strong enough to sustain the manipulations required during DSAEK and PKP. Because there were no cases of IOL decentration during the procedures, we believe the technique provides strong fixation and an adequately stable IOL. A limitation of this study is its short follow-up because with transscleral fixation of IOLs, there is a risk for complications in the late postoperative period resulting from disappearance of fibrin glue. There is also the possibility of inadequate scleral-flap healing. In summary, fibrin glue-assisted intrascleral fixation of a PC IOL combined with DSAEK or PKP was a safe and effective method to manage pseudophakic corneal edema with aphakia or a malpositioned IOL. Although our initial results with this technique are good, larger comparative trials with a longer follow-up are needed to evaluate the longterm outcomes and to provide more conclusive evidence.

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WHAT WAS KNOWN  Intrascleral haptic fixation of a PC IOL with fibrin glue is a known technique for the visual rehabilitation of aphakia with inadequate or absent capsule support.  There are very few isolated case reports of the technique combining scleral fixation of IOL and DSAEK. WHAT THIS PAPER ADDS  Intrascleral haptic fixation of a PC IOL with fibrin glue offers adequate stability to the IOL so it can sustain manipulations required for DSAEK or PKP.  In cases of aphakia, there is a risk for posterior migration of injected air and dislocation of the lenticule into the vitreous cavity. A posterior chamber IOL fixated intrasclerally prevents posterior migration of air bubble, thereby enabling good air tamponade, which in turn may provide a better chance of donor lenticule adhesion.

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First author: Rajesh Sinha, MD, FRCS Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India