Multicenter evaluation of the safety and efficacy of an ocular sealant after cataract surgery with a premium intraocular lens Y. Ralph Chu 1 Steven J.

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Presentation transcript:

Multicenter evaluation of the safety and efficacy of an ocular sealant after cataract surgery with a premium intraocular lens Y. Ralph Chu 1 Steven J. Dell 2, John A. Hovanesian 3, Farrell C. Tyson 4, Mitch A. Jackson 5, John F. Doane 6 1 Chu Vision Institute, Bloomington, MN; 2 Texan Eye, Austin, TX; 3 Harvard Eye Associates, Laguna Hills, CA; 4 Cape Coral Eye Center, Cape Coral, FL; 5 Jacksoneye, Lake Villa, IL; 6 Discover Vision Centers, Independence, MO Study sponsored by Ocular Therapeutix, Inc. Y. Ralph Chu, Steven J. Dell, and John A. Hovanesian have financial interests in the company.

Purpose To investigate the safety and efficacy of the ReSure ® Sealant (Ocular Therapeutix, Inc.) compared to suture after cataract surgery in Crystalens ® (Bausch&Lomb) premium intraocular lens patients for prevention of fluid egress following cataract surgery.

Methods Uncomplicated cataract surgery with Crystalens premium intraocular lens (IOL) implantation 32 patients enrolled: ▫20 subjects randomized to the ReSure Sealant ▫12 subjects randomized to receive a single suture (3-1-1 technique with buried knot) Wound leads were evaluated using a Seidel test and Ocular Force Gauge (OFG). Follow-up visits scheduled at Days 1, 3, 7, 14, 21, and 28. Intraocular pressure and a slit lamp examination were performed at each visit.

Evaluation of Fluid Egress A Seidel test was performed to evaluate fluid egress in all patients. If spontaneous leak was observed the patient was enrolled into the study. If spontaneous leak was not observed, wounds were challenged using an Ocular Force Gauge (OFG)(Ocular Therapeutix, Bedford, MA). The foot of the applicator was placed near the CCI on the scleral side of the wound. Force was applied until a leak was observed, up to one ounce maximum.* If no leak was observed with up to one ounce force, the patient was not enrolled in the study. Foot *1.00 oz. force has previously been evaluated to elevate IOP a mean mmHg, consistent with light and firm digital pressure application in the literature. 1 1 Masket S, Hovanesian J, Raizman M, Wee D, Fram N. Use of a calibrated force gauge in clear corneal cataract surgery to quantify point-pressure manipulation. J Cataract Refract Surg Feb 21.

Pre-randomization leak rates

Post-randomization leak rates ReSure Sealant demonstrated superiority over sutures for prevention of wound leaks (5.0% vs. 41.7%, respectively) (p=0.0070) Significantly fewer adverse events in the ReSure group vs. Suture group (10.0% vs. 50.0%, respectively) (p=0.0302)

Additional Results No differences in: ▫Anterior chamber cells ▫Edema ▫Flare ▫Overall wound healing No safety concerns were reported Patients were comfortable overall Mean Intraocular Pressure (mmHg)

Conclusions The incidence of wound leaks and AEs were substantially fewer in the ReSure group after Crystalens implantation. There were no significant differences in overall wound healing, intraocular pressure, or edema, flare, or cells. Given the larger incision size required for Crystalens patients, the ReSure Sealant may offer a better alternative to wound closure than sutures.