Evaluation of Ocular Sealant for Prevention of Fluid Egress After Cataract Surgery: Multicenter Randomized Pivotal Trial
Narrative Responses:
Purpose
To evaluate the effectiveness of an ocular sealant (ReSure® Sealant, Ocular Therapeutix, Inc., Bedford, MA) against suture(s) for prevention of fluid egress in patients with a demonstrated clear corneal wound leak.
Methods
487 healthy patients at 24 sites undergoing uncomplicated cataract or intraocular lens placement surgery with incisions ≤ 3.5 mm were randomized in a 5:3 ratio to receive the sealant or suture(s), respectively. 10-0 nylon sutures were placed using a 3-1-1 technique with buried knot. A Seidel test was performed to evaluate spontaneous leaks, and a Calibrated Force Gauge was used on the remaining wounds to challenge the effectiveness of each device by placing up to 1.0 oz. force on the scleral side of the limbus next to the incision, simulating intraocular pressure fluctuations which may be caused by patient manipulation.
Results
50% of eyes exhibited spontaneous leakage prior to randomization. After device application, sutures (n=183) presented a wound leak rate of 31.7%, whereas the sealant (n=304) presented a wound leak rate of only 3.6%, demonstrating statistical superiority over sutures (p<0.0001). 30.6% of sutured patients experienced at least one device-related adverse event (AE), compared to only 1.6% of sealant patients (p<0.0001). 12.6% of sutured patients required premature device removal due to an AE, compared to sealant patients at 0.3%. Remaining sutures were removed at day 28, whereas the sealant sloughed off in the first post-operative week. Patients were comfortable overall.
Conclusion
The ReSure Sealant demonstrated superiority in prevention of fluid egress from wounds with a demonstrated wound leak, and presented less adverse events than sutures. Fluid egress has been linked to a number of post-operative complications, and in this study, the ReSure Sealant was more effective with less complications than sutures.