Multicenter Evaluation of Safety and Efficacy of Ocular Sealant After Cataract Surgery With Premium IOL

Chu, Y. Ralph

Multicenter Evaluation of Safety and Efficacy of Ocular Sealant After Cataract Surgery With Premium IOL

Friday, April 25, 2014

KIOSKS (Boston Convention and Exhibition Center)

Y. Ralph Chu, MD, Chu Vision Institute, Bloomington, MN, USA

Steven J. Dell, MD, Texan Eye, Austin, TX, USA

John A. Hovanesian, MD, Harvard Eye Associates, Laguna Hills, California, USA

Farrell C. Tyson, MD, FACS, Cape Coral Eye Center, Cape Coral, FL, USA

Mitchell A. Jackson, MD, Jacksoneye, SC, Lake Villa, IL, USA

John F. Doane, MD, Discover Vision Centers, Leawood, Kansas, USA

Narrative Responses:

Purpose
To investigate the safety and efficacy of ReSure® Sealant (Ocular Therapeutix, Inc.) compared to suture after cataract surgery with a premium intraocular lens, Crystalens® (Bausch & Lomb).

Methods
Following cataract surgery with Crystalens premium intraocular lens (IOL) implantation, 20 subjects were randomized to the ReSure Sealant and 12 were randomized to receive sutures. Incision leak rate was tested with Seidel test under no and minimal provocation using Calibrated Force Gauge (CFG) with up to 1 ounce force. Subject follow-up visits occurred at Days 1, 3, 7, 14, 21, and 28. Intraocular pressure and slit lamp examination were performed at each visit.

Results
1 of 20 (5%) ReSure Sealant-treated subjects leaked under CFG manipulation compared to 5 of 12 (42%) suture-treated subjects (p=0.0070). Mean incision width was 2.85±0.19 mm. ReSure subjects had a mean IOP of 14.49±2.94 mmHg at baseline and a mean IOP of 17.85±3.68 mmHg on postoperative Day 1 compared to 14.92±1.66 mmHg and 18.67±7.44 mmHg at the same time points for subjects who received suture, respectively. There were no differences in edema, flare, or cells at days 7 and 28. 50% of suture subjects had at least one adverse event (AE) compared to only 10% of ReSure subjects (p=0.0302).

Conclusion
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 or IOP. Given the larger incision size required for Crystalens patients, the ReSure Sealant may offer a better alternative to wound closure than sutures.