Dr. Anita Ambastha, A08530,
Dr. Nazia Imam, Dr. Gyan Bhaskar, Dr. Rakhi Kusumesh
Introduction: SICS remains the most common method of Cataract Surgery in the developing world.Its continuing popularity is not the least because of predictable astigmatism,comparable to phacomulsification in many studies,(1,2,3).SICS is also preferred by many surgeons in cases of large nucleus,(4,5,6) and compromised endothelium. Many of these surgeries are performed by beginners where extended scleral flap, large incisions, torn or buttonholing of scleral flap is not an uncommon complication,(7). These compromized scleral tunnels lead to postoperative wound leak,shallow AC, increased risk of postop endopthalmitis and unpredictable astigmatism,( 6,7,8 ).This has mostly been managed by putting sutures but sutures are associated with suture related complications including Endopthalmitis,(9,10,11)
The purpose of this study was to study the safety and efficacy of Fibrin Glue with infinity sutures in cases of Small Incision Cataract Surgery with extended or buttonholed scleral flap.
MATERIALS AND METHODS: This was a retrospective comparative study of eighteen patients who were operated for cataract by Manual Small Incision Cataract Surgery between Sept 2016 to April 2017. Fibrin glue was used to seal incisions were there was a extended , torn or buttonholed scleral flap and wound integrity was compromised in 18 cases . Horizontal 10-0 monofilament was used in another 18 cases with similar flap related problems. In In all cases rigid 6.0mm posterior chamber lens implantation was done. Ethical clearance was taken. Tenets of the declaration of Helsinki were adhered to.
Fibrin glue is a biological, nonirritating substance that is absorbed in a few days, inducing collagen formation and cross-linking and thus promoting natural wound healing. 11The tensile strength of a clot formed with fibrin seal is approximately 200 g/cm2(17 kPA),(12). The clotting procedure is fast, with firm adhesion in three to five seconds,(11). Fibrin glue can also be used on wet tissue surfaces,(12).
The fibrin glue is applied using a double syringe that allows the two sealant components to be thoroughly mixed with one hand immediately before wound closure. It is important to apply the glue at 36 degrees Celsius. A thin film of glue was applied to the posterior part of the scleral pocket along its entire length . The conjunctiva was fixed onto the sclera with drops of fibrin. After the glue is applied fibrin consolidates in a few seconds.The wound was kept dry to enhance the adhesive strength of fibrin,( 11 ) .
We evaluated the effect of fibrin glue on wound closure,postop AC depth ,anterior chamber inflammation,IOP , postoperative astigmatism in eighteen consecutive patients . Patients were evaluated preoperatively and postoperatively at Day one, and end of One week,Four weeks and Six Weeks respectively. Astigmatism analysis was restricted to keratometric readings.SIA was examined by SIA Calculater version2.1. Data was analyzed by Epi Info 7 software.Size of incision was mean 7.20mm(range6.O-8.0 mm).
| Day I | 1 week | 4 week | 6week | |
| Integrity of wound | No wound gape
|
Subconjunctival
Bleb in one case |
No wound gape | No wound gape |
| Amount of inflammation | Minimal | minimal | Minimal | Minimal |
| Ant. Chamber depth | formed | formed | Formed | Formed |
| IOP by NCT | WNL | WNL | WNL | WNL |
RESULTS Postop slitlamp examination in SICS with fibrin glue
FIG 1
Postop slitlamp examination in SICS with sutures
| Day 1 | 1 week | 4 week | 6week
|
|
| WOUND INTEGRITY | WELL APPOSED | EXPOSED
KNOTS-5 CASES |
WELL APPOSED.SUTURES
REMOVED IN 5 CASES |
WELL
APPOSED |
| Amt of inflammation | Minimal | Minimal | Minimal | Minimal |
| AC DEPTH | FORMED | FORMED | FORMED | FORMED |
| IOP | WNL | WNL | WNL | WNL |
Fig 2
Statistical Analysis of difference in Astigmatic changes in Postop Visits in SICS with Suture VS SICS with glue
| Mean SIA
As plus cylinder/sutures |
SD
As plus cylinder/glue |
Tvalue | p value | |
| Day 1 | 1.99+-1.33 | 1.78+-1.30 | 0.49 | 0.62 |
| 1 week | 1.88+-1.09 | 2.77+-1.08 | -0.99 | 0.035 |
| 4 weeks | 1.77+-1.26 | 1.66+-0.75 | 0.23 | 0.81 |
| 6weeks | 1.76+-1.23 | 1.56+-0.69 | 0.49 | 0.621 |
FIG 3
Postoperative inflammation was minimal in all eyes.Subconjunctival bleb formation was seen in one patient with premature wound entry.However AC was formed and IOP was WNL.The bleb flattened by the end of second week. IOP was WNL in all cases.There was a steady increase in the SIA from first (mean SIA 1.78+-1.30) to seventh postoperative day (mean SIA 2.77+-1.08) which was significant and against the rule. Thereafter mean SIA decreased to 1.66+-0.75 at the end of first month.This was not significantly different from first postop day. At the end of six weeks,mean SIA was1.56+-0.69 ,ATR,with no statistically significant difference between the SIA from first to fortyfifth postoperative day.
Postop there was no complaint of foreign body sensation and no occurrence of Giant papillary conjunctivitis or Endopthalmitis. In patients were SICS with infinity sutures was given, mean SIA on first postop day was 1.99+-1.33. It decreased to mean SIA 1.88+-1.09 at the end of first week whhich was not significantly different from first post op day. At the end of one month Mean SIA was 1.77+-1.26 and at the end of 6 weeks it was 1.56+-0.69,both of which was not significantly different from mean SIA of first postop day. Difference in mean SIA between the two groups was significant at the end of first postop week(p<0.035). On all other days mean SIA in SICS with glue group was less than SICS with suture though the difference was not significant. At the end of 6 weeks there was no statistically significant difference in SIA between the two groups. Exposed suture knots were seen in 5 patients which were causing FB sensation and redness. They were removed at the end of 4 weeks.AC was formed,wound well opposed,inflammation minimal and IOP WNL on all postop days.
Discussion Small Incision Cataract Surgery with extended or buttonholed scleral flap has usually been managed by sutures but sutures are associated with complications. Cyanoacrylate glue is not favoured as it forms a solid, impermeable mass in situ which acts as a foreign body causing inflammatory reactions like giant papillary conjunctivitis and corneal neovascularization,(13). Unlike cyanoacrylate glue, fibrin glue forms a uniform seal along the length of the wound edge and hence provides greater postoperative comfort to the patient with fewer complications,(14).Though Fibrin glue has been used in scleral pocket phacoemulsification for controlling SIA in previous studies but literature regarding use of fibrin glue in extended or buttonholed sclera l pocket incision in manual Small incision cataract surgery and its outcome revealed no such study.
Buschmann W,(15) has used fibrin intraocularly to close traumatic defects of the lens capsule without reporting any side effects.Alvarado,(16) et al evaluated the inflammatory activity with bioadhesives such as fibrin and cyanoacrylate versus unsutured valved closure and suturing. They demonstrated that on day thirty, both fibrin and cyanoacrylate adhesives had generated a slightly greater inflammatory response than sutured and unsutured techniques for closure in his cases. Kim JC et al,(17) noted that although cyanoacrylate glue initially demonstrates a strong adhesive quality, it causes a severe inflammatory response that inhibits subsequent collagen remodeling. They concluded that Fibrin tissue adhesives may have an application as adjunctive means of closing scleral tunnel incisions. In our study however postoperative inflammation was minimal in all eyes.
There was no wound leak in seventeen of our cases. Only one case showed presence of subconjunctival bleb formation where premature entry(p>.05) was recorded in medical records .However AC was formed and IOP WNL on all days. A t the end of second week the bleb had flattened .This could be due to the reconstituted fibrin glue forming a coagulum and not a thin layer in this case, as required, due to failure to maintain required temperature during reconstitution. This may have decreased the adhesiveness of the fibrin glue which took time to seal the wound. Henrick,( 18)found that applying fibrin glue in rabbits led to equal or superior scleral incision wound closure compared to suturing . Alió JL,(19) et al tested the efficacy of synthetic , biological bioadhesives and 10-1 nylon anchor suture for incision closure in scleral tunnel phacoemulsification in 126 eyes with high myopia( axial length > 28.0 mm) and noted that in the fibrinogen group, 3 eyes developed postoperative hypotony requiring reclosing of the incision with sutures and 5 eyes developed intraoperative hypotony requiring suture closure.However we did not come across any incidence of hypotony in our cases.The reason maybe that in high myopia there is low scleral rigidity ,(20)and fibrin glue is unable to provide the required tensile strength to the wound margin in these cases. Henrick A etal ,(21)analyzed the use of biologic glue in posterior beveled and scleral pocket incisions for cataract surgery in fresh cadaveric eyes and closed them with nylon sutures, glue, or a combination of both and concluded that biologic glue was an alternative to suture closure of scleral pocket cataract incisions. Shigemitsu et al, (22) demonstrated that both cyanoacrylate and fibrin glue had tensile strength comparable to the sutures used in cataract surgery.
In our study, mean SIA at the end of 6 weeks postop was ATR 1.76+-1.23 in SICS with suture while it was 1.56+-0.69 in SICS with glue .
Mester et al,(20) discussed astigmatism after phacoemulsification with scleral pocket incision using small incision technique with fibrin adhesive for wound closure and concluded that Surgically induced astigmatism was smaller in the fibrin group (vector analysis: 0.80 diopters [D]) than in the single-stitch group (vector analysis: 0.99 D).The increased ATR in our cases could be due to increased length of the scleral incision and extended or buttonholed scleral flap,(23). We found significant increase in ATR at the end of 1st week in SICS with glue grp which could be due to an intraoperative or postoperative dehiscence of the scleral wound lips caused by increased intraocular pressure (lOP) in the initial phase of wound healing,(24) and the fact that Clot organization takes two weeks to complete after glue application,(11). Another added reason could be the subconjunctival bleb formation in one case which showed higher SIA at the end of first week. Alió JL,(20) etal noted that the difference in Mean induced astigmatism at twelve weeks between the bioadhesive groups and the suture group was not significant in there cases.
Postoperatively, 5 patients in SICS with suture group developed exposed suture knots with complaints of FB Sensation and redness. None of the SICS with glue patients showed any such discomfort and patent satisfaction was more in them.
Conclusion Biologic Fibrin glue can be safely used in securing the scleral pocket incision in SICS when there is extended scleral flap or buttonholing of the scleral flap. It strengthens the incision margin, prevents unpredictable astigmatism and does not cause untoward inflammation or hypotony. It also avoids suture relared complications.
References
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Acknowledgement The authors acknowledge the use of the SIA Calculator version2.1,2010,Dr Saurabh Sawhney, Dr Aashima Aggarwal in the present study
.
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