Single-Site Evaluation of Ocular Sealant Compared With Suture for Prevention of Clear Corneal Incision Leaks After Cataract Surgery
Narrative Responses:
Purpose
To evaluate the safety and effectiveness of the ReSure Sealant (Ocular Therapeutix, Inc.) compared to suture(s) for preventing incision leakage from clear corneal incisions (CCI) within the first 7 days of surgery for patients undergoing uneventful clear corneal cataract surgery with phacoemulsification and intraocular lens (IOL) placement.
Methods
Following cataract surgery conducted by two surgeons at one institution, 20 subjects (20 eyes) with a demonstrated wound leak were treated with the ReSure Sealant or suture and evaluated for 28 days post-procedure. Incisions were tested for spontaneous or unprovoked leaks via Seidel test. If no spontaneous leak was observed, incisions were provoked using a Calibrated Force Gauge (CFG) using up to 1 ounce force (ozf) next to the incision. Following treatment with the ReSure Sealant or suture, a second leak assessment was conducted using the CFG. A Seidel test was also performed at 1, 3, 7 and 28 days.
Results
11 of the 20 eyes (55%) leaked spontaneously pre-randomization immediately following cataract surgery. The remaining 9 eyes leaked with minimal provocation (≤ 0.50 ozf) with the CFG. Post-randomization, 0 of 13 (0%) ReSure Sealant-treated subjects and 3 of 7 (43%) suture-treated subjects leaked upon provocation with the CFG. Mean incision width and tunnel length for ReSure Sealant-treated subjects were 2.69 ± 0.30 mm and 1.91 ± 0.31 mm, respectively, and 2.91 ± 0.12 mm and 1.83 ± 0.49 mm, respectively, for suture treated subjects. No ReSure Sealant-related adverse events were experienced. One suture-related adverse event was reported.
Conclusion
The ReSure Sealant is significantly superior to sutures for the prevention of clear corneal incision leaks in patients undergoing cataract or intraocular lens placement surgery. Additionally, it has been demonstrated that the ReSure Sealant is at least as safe as sutures for ophthalmic use after cataract surgery.