349Journal of Pediatric Ophthalmology & Strabismus • Vol. 51, No. 6, 2014

INTRODUCTIONThe aim of surgery in strabismus is not only

to improve cosmetic appearance, but also to attain some grade of binocular single vision sufficient to maintain alignment of the eyes.1

Several materials have been used in strabismus surgery to attach the muscle to the sclera. Initially, silk suture was used to anchor the muscle to the sclera; however, it was associated with granuloma

formation, conjunctival inflammation, hypersensi-tivity, or allergic reaction and is also more irritat-ing to the patient.2 When 6-0 polyglactin became available, it became the suture of choice for sur-geons because it is absorbed and is associated with less postoperative reaction.2 The use of polyglactin suture also has been reported to be associated with complications such as postoperative inflammation, granuloma formation, and irritation.2

Purpose: To compare the safety and efficacy of fibrin glue and cyanoacrylate glue for refixating the recessed muscle to the sclera in patients undergoing strabismus surgery.

Methods: In this prospective, randomized, and inter-ventional case series, there were 15 patients in each group. Two different types of glue were used for refix-ating the muscle to the sclera after its recession: fibrin glue (fibrin group) and cyanoacrylate glue (cyanoacry-late group). Resection was performed as usual with a 6-0 polyglactin suture. The conjunctiva was closed with the same glue that was used for muscle recession.

Results: Average time required per muscle attachment was 1.48 ± 0.694 minutes in the fibrin group and 2.42 ± 0.584 minutes in the cyanoacrylate group. There was no significant difference in pain at all postoperative visits in both groups. Significantly more chemosis was

observed in the cyanoacrylate group at postoperative 3 weeks. At all other postoperative visits, there was no significant difference in chemosis in both groups. There was significantly more conjunctival reaction in the cya-noacrylate group at 1 and 3 weeks and 3 months; the difference was highly significant at 3 months (P = .00). Total inflammatory score was significantly high in the cyanoacrylate group at 1 week, 3 weeks, and 3 months.

Conclusions: Both fibrin and cyanoacrylate glue are equally efficacious for muscle reattachment; however, fibrin glue is more biotolerant compared to cyanoacry-late glue and results in less postoperative inflammation, and is thus recommended for recession in strabismus surgery.

[J Pediatr Ophthalmol Strabismus 2014;51(6):349-354.]

ABSTRACT

Comparative Evaluation of Cyanoacrylate and Fibrin Glue for Muscle Recession in Strabismus Surgery

Pratik Topiwala, MS; Rakesh K. Bansal, MS, FRCSEd

From the Department of Ophthalmology, Government Medical College and Hospital, Sector 32, Chandigarh, India.Submitted: May 14, 2014; Accepted: September 24, 2014; Posted online: November 26, 2014The authors have no financial or proprietary interest in the materials presented herein.Correspondence: Rakesh K. Bansal, MS, FRCSEd, Department of Ophthalmology, GMCH-32, Chandigarh, India. E-mail: bansalrk@hotmail.comdoi: 10.3928/01913913-20141021-10

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Over the past 10 years, several glues have be-come available and their use has been reported in various surgical procedures in ophthalmology.3-17 Darakshan and Amitava5 used cyanoacrylate glue for fixing the recessed muscle to the sclera and com-pared the results with 6-0 polyglactin suture. They found cyanoacrylate glue safe and effective.

Fibrin glue has also been used in humans for stra-bismus surgery, but mainly for closing the conjunc-tiva.18 There are studies on the use of fibrin glue for attaching the muscle to the sclera and results have been compared with other glues and sutures.15 These studies have shown that fibrin glue is superior to cyanoacrylate glue in terms of biocompatibility; however, bonding strength of cyanoacrylate glue is superior to that of fibrin glue. To the best of our knowledge, no studies are available with regard to the use of fibrin glue for refixating the recessed muscle to the sclera in human eyes. We compared the safety and efficacy of fibrin and cyanoacrylate glue for refixating the recessed muscle to the sclera in patients undergoing strabismus surgery.

PATIENTS AND METHODSThe study was conducted in optimally prepared

patients strictly in accordance with the ethical guide-lines for biomedical research on human subjects.

The study was performed in the Department of Ophthalmology at Government Medical College and Hospital, Sector 32, Chandigarh, India. Thirty pa-tients requiring strabismus correction for either esotro-pia or exotropia were included in the study. Patients with incomitant strabismus, history of any other ocular surgery, or strabismus surgery and with history of trau-ma to the eye were excluded from the study. Baseline evaluation included a detailed history with regard to age at onset, progression, and duration of strabismus.

Ocular examination included recording of un-corrected and best-corrected Snellen visual acuity. Retinoscopy under cycloplegia was performed in each patient and glasses were prescribed depending on the refractive error and type of deviation. Fundus exami-nation was performed with dilated pupils. Amblyopia therapy, if required, was performed before any sur-gical correction. Preoperative measurement of devia-tion was done by prism bar cover test for near and distance. Surgery was planned based on the amount and type of deviation. Patients requiring surgery were randomized into two groups. Fibrin glue (Tisseel; Baxter Healthcare Corp., Manesar, Gurgaon, India) was used in the fibrin group and cyanoacrylate glue (XOIN; Reevax Pharma, Hyderabad, India) was used in the cyanoacrylate group for attaching the recessed muscle to the sclera.

Surgical TechniqueThe surgical procedure was performed under

general anesthesia for patients younger than 18 years and under peribulbar anesthesia for patients 18 years and older. For muscle recession, conjuncti-val peritomy was done at the limbus with a fornix-based flap, Tenon’s capsule was separated, and the muscle was bridled with a muscle hook. A tempo-rary 6-0 silk suture was passed through the muscle. The amount of recession required was marked on the sclera and the muscle was reattached at its new marked recessed position with either fibrin glue or n-butyl-2-cyanoacrylate glue as per randomization (Figure 1). Intraoperative time taken for reattach-ment of muscle to the sclera was noted in each case. The temporary silk suture was removed when firm attachment of the muscle to the sclera was ensured. Resection of the muscle was done in the usual man-ner and the muscle was secured to the sclera with 6-0 polyglactin. Conjunctiva was closed on both sides with the same glue, which was used for muscle recession. Postoperative antibiotic and steroid drops were given four times daily for 4 weeks.

Postoperative evaluation for pain, chemosis, and conjunctival reaction was performed at day 1, 1, 3, and 6 weeks, and 3 months. Grading of pain, chemosis, and conjunctival reaction was from 0 to 3 (grade 0: none, grade 1: mild, grade 2: moder-ate, grade 3: severe) by a masked examiner who was not aware of which glue was used. The total score of these three parameters was also calculated at each postoperative visit. Ocular alignment and presence

Figure 1. Attachment of muscle with fibrin glue to the sclera after its recession.

351Journal of Pediatric Ophthalmology & Strabismus • Vol. 51, No. 6, 2014

of binocular single vision were assessed at 3 and 6 weeks and 3 months.

Confidence interval was kept at 95%. Mann–Whitney U test, Student’s t test, and chi-square test were applied for statistical analysis. A P value of less than .05 was considered significant for comparison between the two groups.

RESULTSThere were 21 eyes of 15 patients who under-

went recession in the fibrin group and 19 eyes of 15 patients in the cyanoacrylate group. Demographic details of these patients are given in Table 1.

Mean age of the patients was 11.6 ± 7.49 years (range: 1 to 28 years) in the fibrin group and 12.4 ± 9.982 years (range: 1.5 to 35 years) in the cyano-acrylate group. Both groups were comparable with respect to age (P = .806). There were 8 males and 7 females in both groups.

Average time required per muscle attach-ment was 1.48 ± 0.694 minutes in the fibrin group and 2.42 ± 0.584 minutes in the cyanoac-rylate group.

TABLE 1

Age and Sex Distribution of the Patients

CharacteristicFibrin Group

Cyanoacrylate Group P

Age (y)

Mean 11.6 12.4 .806

Standard deviation

7.49 9.98

Sex distribution

Males 8 8 –

Females 7 7 –

No. of eyes 21 19

TABLE 2

Postoperative Inflammatory Score in Both GroupsParameter Fibrin Group Cyanoacrylate Group P

Pain (mean ± SD)

Day 1 0.43 ± 0.598 0.63 ± 0.684 .598

1 week 0.10 ± 0.301 0.32 ± 0.478 .082

3 weeks 0.00 ± 0.00 0.16 ± 0.375 .058

3 months 0.00 ± 0.00 0.05 ± 0.229 .287

Chemosis (mean ± SD)

Day 1 1.05 ± 0.384 1.21 ± 0.631 .140

1 week 0.62 ± 0.498 0.68 ± 0.478 .666

3 weeks 0.10 ± 0.301 0.37 ± 0.496 .039

3 months 0.00 ± 0.00 0.16 ± 0.375 .058

Conjunctival reaction (mean ± SD)

Day 1 1.38 ± 0.498 1.53 ± 0.513 .356

1 week 0.81 ± 0.402 1.26 ± 0.452 .01

3 weeks 0.33 ± 0.483 0.68 ± 0.478 .027

3 months 0.00 ± 0.00 0.53 ± 0.513 .00

Total inflammatory score (mean ± SD)

Day 1 2.86 ±1.108 3.37 ±1.383 .186

1 week 1.52 ± 0.928 2.26 ± 0.933 .025

3 weeks 0.43 ± 0.676 1.21 ± 0.787 .002

3 months 0.00 ± 0.00 0.74 ± 0.806 .00SD = standard deviation

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Postoperative alignment within 10 prism di-opters was achieved in all patients at 6 weeks and 3 months except in one case in the cyanoacrylate group who developed consecutive exodeviation. Status of binocular single vision of the patients re-mained unaltered at 3 months of follow-up.

The scores for pain, chemosis, and conjunctival reaction are given in Table 2.

There was no significant difference in pain at all postoperative visits in both groups (chi-square test, day 1 [P = .598], 1 week [P = .082], 3 weeks [P = .058], 3 months [P = .287]).

Significantly more chemosis was observed in the cyanoacrylate group at postoperative 3 weeks (P = .039, chi-square test) (Figure 2). At all other postoperative visits, there was no sig-nificant difference in chemosis in both groups (day 1 [P = .140], 1 week [P = .666], 3 months [P = .058]).

Conjunctival reaction was significantly greater in the cyanoacrylate group at 1 week (P = .01), 3 weeks (P = .027), and 3 months (P = .000). The dif-

ference was highly significant at 3 months (P = .00, chi-square test) (Figure 3).

Total inflammatory score was significantly high in the cyanoacrylate group at 1 week (P = .025) and 3 weeks (P = .002). The difference was highly signif-icant at 3 months (P = .00, Mann–Whitney U test).

Two patients in the cyanoacrylate group developed localized granuloma formation over the site of muscle reattachment and required surgical removal (Figure 4).

DISCUSSIONThe 6-0 polyglactin suture is the most com-

monly used suture for attaching the recessed and resected muscles to the sclera. Searching for better materials has led to the use of various glues for this purpose. Glues with bioadhesive properties such as fibrin, cyanoacrylate, and polyethylene glycol-based compounds have been tested for muscle reattach-ment in animal eyes.9-11 Cyanoacrylate glue has been used in human eyes for muscle reattachment.5,10

Animal studies have shown that glues work bet-ter if the amount of recession is greater than 6 mm. Mulet et al.10 used Adal-1, which is a mixture of eth-yl cyanoacrylate and ethyl carboxylate, and average recession in their patients was 9.9 ± 3.08 mm, with a range of 5 to 14 mm. In the current study, aver-age recession per eye was 5.71 ± 1.963 mm in the fibrin group and 6.05 ± 1.892 mm in the cyanoac-rylate group. There was no muscle slippage in either group. The amount of recession depended on the amount of deviation. Spierer et al.14 compared fibrin glue with polyglactin suture in 42 eyes of 29 rab-bits and observed that for a recession greater than 6 mm, there was no statistically significant difference in muscle slippage between the two groups. They

Figure 2. Significant conjunctival chemosis at 3 weeks postopera-tively in a case of cyanoacrylate glue.

Figure 3. Conjunctival hyperemia at 3 months postoperatively in a case of cyanoacrylate glue.

Figure 4. Conjunctival granuloma at the site of muscle attachment in a case of cyanoacrylate glue.

353Journal of Pediatric Ophthalmology & Strabismus • Vol. 51, No. 6, 2014

concluded that fibrin glue is safe for a recession of more than 6 mm. In our study, mean recession was 5.71 mm in the fibrin group (range: 3.5 to 10 mm) and we did not observe any muscle slippage.

Time for the muscle to attach to the sclera may vary depending on the properties of the glue used. Average time required per muscle reattachment was 1.48 ± 0.694 minutes in the fibrin group and 2.42 ± 0.584 minutes in the cyanoacrylate group. The dif-ference between the two groups was significant (P = .00). The mean time required per muscle attach-ment in a study by Darakshan et al.5 with cyanoac-rylate glue was noted to be 10.29 ± 2.59 minutes (range: 6 to 15 minutes). The glue used by them was isoamyl cyanoacrylate, whereas the glue employed in our study was n-butyl-2 cyanoacrylate, which has better gluing properties. They also observed that dil-igent cauterization of bleeders is likely to markedly reduce the total time of muscle attachment to the globe. Thorough cauterization of bleeders was done in our patients, which could also be responsible for significantly less time taken for muscle reattach-ment. The average time required for muscle attach-ment with fibrin glue in animal eyes was 2 minutes, which is similar to our fibrin group.14

Postoperative pain was similar in both groups at all postoperative visits. There is no difference in postoperative pain with use of cyanoacrylate glue and polyglactin suture in a series by Darakshan and Amitava 5 and Mulet et al.10 However, chemosis was significantly greater in the cyanoacrylate group at 3 weeks. It was noticed that chemosis was similar in both groups until 1 week and significantly reduced after 1 week in the fibrin group. By 3 months, both groups behaved in a similar manner. Thus, it is pre-sumed that chemosis tends to disappear quickly with the use of fibrin glue. No study in the literature has investigated this parameter.

Conjunctival congestion started declining af-ter day 1 in the fibrin group, whereas it persisted in the cyanoacrylate group and lasted until 3 months. Darakshan and Amitava5 found no significant dif-ference in conjunctival injection between cyano-acrylate glue and sutures. Mulet et al.10 observed a significantly greater degree of conjunctival injection in the polyglactin suture group in the immediate postoperative period (1 and 3 months after surgery) when compared with Adal-1. Although the data in the current study are not comparable with those of Mulet et al.,10 it can be observed that cyanoac-

rylate glue produces a lesser reaction compared to polyglactin suture but a more conjunctival reaction compared to fibrin glue. We also observed that there was more overall inflammation in the cyanoacrylate group compared to the fibrin group. Tonelli et al.15

also observed that tissue reaction produced by cya-noacrylate glue is more comparable to that of fibrin glue and is similar to our observation.

Two patients in the cyanoacrylate group devel-oped foreign body granuloma, necessitating surgical removal. Cyanoacrylate glue has a tendency to form a mass when applied to the surface that behaves like a foreign body and results in inflammatory reactions and conjunctival ulcerations.19 Mulet et al.10 re-ported two cases of granuloma in the cyanoacrylate group with the use of Adal-1. It may have better bio-tolerability than n-butyl-2 cyanoacrylate when used alone. Ethyl carboxyacrylate is supposed to act as a plastifier, improving flexibility, producing less exo-thermal reaction, and hence reducing toxicity. We did not observe any case of conjunctival ulceration in the cyanoacrylate group because the glue was ap-plied beneath the muscle bulk; hence, the spicules of glue could not cause any conjunctival ulceration.

As made evident by our study, fibrin and cya-noacrylate glue are equally efficacious for muscle reattachment; however, fibrin glue is more biotoler-ant compared to cyanoacrylate glue and results in less postoperative inflammation. Our study recom-mends the use of fibrin glue as a safe, effective, and biotolerant alternative to sutures and cyanoacrylate glue for recessions in strabismus surgery.

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