EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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EW RESIDENTS 64 December 2014 and postoperative endophthalmitis. One retrospective analysis cited by the authors demonstrated a 44-fold increased risk of endophthalmitis with a wound leak during the first postoperative day. 5 However, there were no cases of endophthalmitis in either treatment group of this study to prove or disprove this theory, and a much larger cohort of patients would be required to demonstrate this difference for such a rare event. The study confirmed that the hy- drogel sealant is well tolerated by patients and easy to apply, although there was no statistically significant difference in any of the secondary outcomes including astigmatism, OCI results, or BCVA. In this study, the cases com- pared were all deemed "routine," and yet the great majority of sur- geons do not perform any wound closure apart from stromal hydration in such cases. 1 The use of sutures is typically reserved for cases with greater complexity, such as flop- py iris, sulcus lens placement, or vitreous loss. As these cases were not compared in this trial, it is difficult to apply the study results for the cases where sutures are used most. Another limitation of this study is the method of wound creation that was employed during cata- ract surgery. The study's choice of a uniplanar incision resulted in an exceedingly high initial rate of wound leakage after surgery (98% of patients). Multiplanar incisions have been shown to have greater stability compared to single plane incisions, and testing of multiplanar incisions would likely result in significantly lower initial rates of wound leakage. 6 In fact, the same study group led by Dr. Masket demonstrated that bipla- nar incisions had a lower incidence of leakage compared to single inci- sions when testing their Calibrated Force Gauge. 4 Given this knowledge, it is unclear why an arm for multi- planar incisions was not investigated in the current study. The size of the incision was also not well defined by the authors beyond requiring that the length be less than 3.5 mm in length. It would be very important to know if there were any differenc- es in incision size between the two groups, as this would likely influ- ence leakage rate. A recent review by Dewey et. al recommended a 2.2 mm incision as the ideal length minimizing the amount of astigma- tism. 7 Finally, as mentioned above, it is unclear what methods were used at the surgeon's discretion in of 1.6% in the hydrogel group versus 0.5% in the suture group. The incidence of minor device- related adverse events including irritation, foreign body sensation, and subconjunctival hemorrhage were higher in the group of patients that received sutures (30.6%) than hydrogel sealant (1.6%) (p<0.0001). However, there was no significant difference between the two groups in the results of the OCI, suggesting that the majority of this difference is attributed to subconjunctival hem- orrhage in the suture group. The au- thors later state that the percentage of patients with at least one adverse event was similar between the two groups and that the majority were minor in severity. There were no statistically significant differences in the secondary endpoints: BCVA, IOP, and astigmatism. The strengths of this study include the large number of patients and prospective, randomized design. The authors demonstrated that wounds as constructed and tested in the study were more effectively sealed with ReSure Sealant than a suture up to postoperative day 7. In theory, fewer wound leaks prevents fluid ingress into the wound, a source of bacterial entry best corrected visual acuity (BCVA), intraocular pressure (IOP), ocular comfort measured with the Ocular Comfort Index (OCI), and surgically induced astigmatism as secondary endpoints. Non-inferiority was analyzed with one-sided tests with a 5% significance level. Other statis- tical tests were two-sided with a 5% significance level. After randomization, the two groups of patients had no statisti- cal differences in gender, race, age, ethnicity, tobacco use, or diabetic status. By the seventh postopera- tive day, leakage occurred in 4.1% of wounds sealed with hydrogel compared to 34.1% of the sutured wounds, with the vast majority of leakage events occurring in the immediate postoperative period. This was statistically significant (p<0.0001). Only 2 eyes in the su- ture group and 1 eye in the sealant group leaked between days 1 and 7, demonstrating that the greatest po- tential benefit of the sealant occurs during the first postoperative day. There was no statistically significant difference in the number of severe adverse events between the two groups relating to the intervention as determined by the Medical Moni- tor, although there was an incidence Review of continued from page 62 Left to right (standing): Albert Hazan, MD, Brad Kligman, MD, Megan Ridley-Lane, MD, Gregory Stein, MD, and Stacy Scofield, MD. Left to right (sitting): Larissa Habib, MD, and Dov Sebrow, MD Source: Bryan J. Winn, MD