Jeffrey Levenson , MD, Levenson Eye Associates Farrell Tyson II, MD, Cape Coral Eye Center

1. Evaluation of wound closure using sutures for prevention of fluid egress in clear corneal cataract incisions Jeffrey Levenson, MD, Levenson Eye Associates Farrell Tyson II, MD, Cape Coral Eye Center William Flynn, MD, Rashid, Rice & Flynn Eye Associates The authors have no financial interest in the subject matter of this e-poster.

2. Background J Cataract Refract Surg2005; 31:735–741 “Postoperative contamination is a problem with sutureless incisions…” “Our greatest association was a leaky wound on the first postoperative day… with a 44-fold increased risk...”

3. Purpose To evaluate the effectiveness of suture(s) for wound closure to prevent fluid egress from clear corneal cataract incisions (CCI).

4. Wound Challenge Method Depressed Calibrated Force Gauge A Calibrated Force Gauge (CFG) was developed to apply consistent and quantifiable force to the ocular surface. Up to 1 ounce of force applied 0.5 mm away from the scleral side of the incision. Incision monitored for Seidel and recorded for wound leaks in 0.25 ounce force increments.

5. Clinical Sites Levenson Eye Associates, Jeffrey Levenson, MD Cape Coral Eye Center, Farrell Tyson II, MD R & R Eye Associates,William Flynn, MD Harvard Eye Associates, John Hovanesian, MD Associated Eye Care, Stephen Lane, MD Ophthalmic Consultants of Long Island, Eric Donnenfeld, MD Ophthalmic Consultants of Boston, Michael Raizman, MD Chu Vision Institute, Y. Ralph Chu, MD Ophthalmic Consultants of Connecticut, Robert Noecker, MD Chicago Cornea Consultants, ParagMajmudar, MD Ophthalmic Consultants of Boston, Bonnie Henderson, MD Ophthalmic Partners of Pennsylvania, Richard Tipperman, MD Midwest Center for Sight, James Katz, MD Discover Vision Centers, John Doane, MD Texan Eye, Steven Dell, MD Jacksoneye, Mitchell Jackson, MD Pepose Vision Institute, Jay Pepose, MD Duke Eye Center, Preeya Gupta, MD Alterman, Modi & Wolter, SatishModi, MD Cincinnati Eye Institute, Michael Snyder, MD Comprehensive Eye Care, Michael Korenfeld, MD Fichte, Endl & Elmer Eyecare, Michael Endl, MD See Clearly Vision, Rajesh Rajpal, MD TalamoLaser Eye Consultants, Jonathan Talamo, MD

6. Enrollment Criteria Uneventful clear corneal cataract surgery. Single plane incision (no groove). Study eye brought to physiological pressure. Seidel positive incision upon first challenge with CFG prior to suture placement.

7. Methods One or more 10-0 nylon sutures were placed perpendicular to the incision using a 3-1-1 technique with buried knot. Stromal hydration administered at the Investigator’s discretion. The CFG was used a second time to challenge the wound and examined for Seidel. Seidel test was repeated at 1, 3, 7 and 28 days post-operatively.

8. Surgical Characteristics 183 patients enrolled in the study:

9. Results

10. Results • Before Suture: • 51% of wounds leaked spontaneously • 74% of wounds leaked spontaneously or with ≤ 0.25 ounces of force (minimal touch) • After Suture: • 31.7% of sutured wounds leaked with ≤ 1.0 ounce of force • 30.6% of subjects experienced at least one suture-related adverse event including: • Subconjunctival hemorrhage • IOP ≥ 30 mmHg or 10 mmHg over baseline • Induced corneal astigmatism (threshold of 3 diopters) • Corneal edema • Pain/discomfort

11. Conclusion Of the sutured wounds that leaked, 43.1% leaked spontaneously or with minimal touch pressure (≤ 0.25 ounces of force). Sutured wound closure, although considered the “gold-standard” for CCI wound closure, may be subject to wound leaks post-operatively. More protection may be necessary to safeguard CCIs in the immediate post-operative period.