Single-Center Results of Ocular Sealant Evaluation Compared With Suture in Preventing Clear Corneal Incision Leakage After Cataract Surgery
Narrative Responses:
Purpose
To evaluate the safety and efficacy of the ReSure® Sealant (Ocular Therapeutix, Inc.) compared to suture for the prevention of wound leaks from clear corneal incisions in patients undergoing cataract surgery with phacoemulsification and intraocular lens placement.
Methods
40 eyes from a single site of 3 surgeons were treated as part of a prospective, randomized, parallel arm, controlled multicenter trial. Subjects were randomized to either the ReSure Sealant or suture if determined to be Seidel positive, either spontaneously or upon challenging with up to 1 oz. force using a Calibrated Force Gauge (Ocular Therapeutix, Inc.) immediately following cataract surgery. After device application, wounds were challenged again using the same method, and Seidel positive incisions were considered primary endpoint failures. Subjects were evaluated through Day 28, and a Seidel test was performed at Days 1, 3, 7 and 28.
Results
Prior to device randomization, 26 of 40 eyes (65%) leaked with no provocation, and 13 of the remaining 14 eyes (93%) leaked with ≤0.50ozf of provocation. After treatment, 0 of 24 (0%) subjects in the ReSure group and 5 of 16 (31%) subjects in the Suture group leaked when provoked. Mean incision width and tunnel length for the ReSure group was 2.62±0.16mm and 2.70±0.30mm, respectively. Mean incision width and tunnel length for the Suture group was 2.64±0.15mm and 2.73±0.35mm, respectively. 33% of subjects in the ReSure group versus 69% of subjects in the Suture group experienced transient adverse ocular events.
Conclusion
The ReSure Sealant was superior compared to sutures for preventing wound leaks in patients undergoing cataract surgery. Additionally, the ReSure Sealant was at least as safe as sutures demonstrated by the substantially lower adverse event rate.