Epithelial separator demonstrates excellent performance

July 15, 2005

Washington, DC—The automated, disposable Epi-K epithelial separator (Moria) safely and reliably cleaves the epithelium to create high-quality flaps and beds, and its use in Epi-LASIK is associated with favorable results with regard to postoperative pain and visual recovery profiles, said Daniela Jardim, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

"Recognition that the adverse effects of certain LASIK flap-related complications may not be amenable to further improvement combined with the emergence of customized ablation has driven a resurgence of interest in surface ablation procedures," said Dr. Jardim, clinical fellow in vision correction surgery, New York Eye and Ear Infirmary, New York.

The early outcomes assessment focused on surgeon ratings of the quality of the flap, bed, and interface; self-ratings of postoperative pain; and recovery of uncorrected visual acuity (UCVA).

Analyses of flap dimensions and anatomic quality showed reliability of Epi-K performance. Mean ± SD thickness of the epithelial flaps was 47.97 ± 10.33 mm. The mean hinge length was 4.08 ± 0.96 mm, and mean vertical and horizontal diameters were 8.63 ± 0.91 mm and 8.70 ± 0.40 mm.

Intraoperative ratings by the surgeon showed the Epi-K consistently produced high-quality flaps. Edge quality and bed quality were rated as excellent in 49 (98%) eyes, epithelial integrity was excellent in all eyes, and epithelial stretch (1 mm) was consistently good as well. After the flap was repositioned, the interface was rated excellent in 49 (98%) eyes.

Patients were seen each day for the first 5 days after surgery for measurement of UCVA and were asked to rate their pain using a 0 (none) to 10 (worst) severity rating scale and to indicate their ability to work, taking into account their pain and quality of vision.

Mean UCVA was 0.53 on postop day 1, decreased to 0.43 on postop day 2, but then improved rapidly, increasing to 0.62, 0.83, and 0.92 on postop days 3, 4, and 5, respectively. Levels of pain varied widely early after surgery, although by postop day 3, no patient reported significant pain, and all patients were pain-free by postop day 5. The mean rating on the day of surgery was 3, but it decreased by postop day 1 to 1.3, remained at that level on postop day 2, and dropped further to 0.3 on postop days 3 and 4.