Evaluation of Sutures for Wound Closure of Clear Corneal Incisions With Wound Leaks
Narrative Responses:
Purpose
To evaluate the effectiveness of sutures for wound closure following clear corneal cataract surgery in healthy patients with a demonstrated wound leak.
Methods
183 patients with demonstrated spontaneous or provoked wound leaks using a Calibrated Force Gauge (CFG)(up to 1 ozf.) were evaluated in a prospective study at 23 sites in the United States. One or more 10-0 nylon sutures using a 3-1-1 technique with buried knot were used to close the wound. Stromal hydration was used at the investigators’ discretion. A Seidel test was performed to detect any fluid egress, and the CFG was used to challenge wounds by simulating intraocular pressure fluctuations. A Seidel test was performed at days 1, 3, 7, and 28 post-operatively. Sutures were removed at day 28.
Results
Mean incision length was 2.72 mm ±0.21. Prior to suture application, 50.3% (n=93) of wounds leaked spontaneously, and the remaining wounds (n=90) leaked under CFG challenge. 76.9% of wounds were stromally hydrated in conjunction with suture placement. Following suture placement, 2.2% (n=4) of wounds leaked spontaneously, and an additional 29.5% (n=54) of wounds leaked under simulated intraocular pressure fluctuations using the CFG. 30.6% (n=56) of patients experienced at least one suture-related adverse event (AE), and 12.6% (n=23) of sutures had to be prematurely removed due to AEs.
Conclusion
Sutures failed to prevent fluid egress from approximately one-third of clear corneal incisions, and resulted in a number of device-related AEs. Additional measures or alternative devices, such as ocular sealants, may be needed for definitive wound closure without leak.