Multi-Center Study of Safety and Efficacy of Toric IOL and Wound Closure Method After Cataract Surgery

Lane, Stephen

Multi-Center Study of Safety and Efficacy of Toric IOL and Wound Closure Method After Cataract Surgery

Sunday, April 27, 2014: 2:01 PM

Room 152 (Boston Convention and Exhibition Center)

Stephen S. Lane, MD, Associated Eye Care, Stillwater, MN, USA

James A. Katz, MD, The Midwest Center for Sight, Des Plaines, IL, USA

Parag A. Majmudar, MD, Rush University Medical Center, Hoffman Estates, Illinois, USA

Bonnie An Henderson, MD, Tufts University School of Medicine, Waltham, MA, USA

Satish S. Modi, MD, FRCS (C), CPI, Seeta Eye Centers, Poughkeepsie, NY, USA

Rajesh K. Rajpal, MD, Cornea Consultants, Mclean, VA, USA

Narrative Responses:

Purpose
To study the safety and efficacy of two wound closure methods, suture versus the ReSure^® Sealant (Ocular Therapeutix, Inc.), after cataract surgery with AcrySof^® Toric (Alcon) intraocular lens implantation.

Methods
49 healthy subjects from 11 sites underwent cataract surgery using an AcrySof Toric intraocular lens. Wounds were secured with sutures (n=19) or the ReSure Sealant (n=30) and tested for leaks via Seidel test under no and minimal provocation using a Calibrated Force Gauge (Ocular Therapeutix, Inc.). Subjects were evaluated at Days 1, 3, 7, 14, 21, and 28. Subjects’ ocular comfort of the study eye was also evaluated.

Results
8 of 19 suture subjects had incisions demonstrate fluid egress (57.9% sealing rate) while only 1 of 30 incisions treated with ReSure Sealant leaked (96.6% sealing rate) (p=0.0011). Baseline IOP for suture patients was 13.89±3.29 mmHg with an increase to 16.21±4.61 mmHg at one day postoperatively. Baseline IOP for ReSure Sealant subjects was 16.07±3.11 mmHg with an increase to 19.87±6.75 mmHg one day postoperatively. 13 (68.4%) subjects experienced adverse events (AE) in the Suture group, while only 5 (30.0%) subjects experienced AEs in the ReSure group (p=0.0173), and none were deemed related to the ReSure Sealant.

Conclusion
ReSure Sealant used in conjunction with AcrySof Toric IOLs significantly reduced the incision leak rate. Additionally, significantly more adverse events were noted in the Suture group. The ReSure Sealant may offer a better means of wound closure than sutures when using toric lenses.