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Epi-LASIK trial will measure patient discomfort

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NEW ORLEANS — A clinical study to measure the level of postoperative patient discomfort after epi-LASIK is set to begin, according to Marguerite McDonald, MD.

The trial, employing the Centurion SES Epikeratome from Norwood EyeCare, will enroll 35 patients at three clinical sites in the United States, Dr. McDonald said during a press briefing here at the American Academy of Ophthalmology meeting. Up to 70 eyes per site will undergo the procedure.

The SES Epikeratome has already received Food and Drug Administration 510(k) approval, but “we’re conducting the study to provide physicians with more information about the technology,” Dr. McDonald said. Among the parameters for study are postoperative discomfort, recovery time and the use of wavefront-guided customized ablation with the epi-LASIK procedure.

The inclusion criteria dictate a myopic range of –0.5 D to –8 D with up to –2.5 D of astigmatism, Dr. McDonald said.

“With criteria like that, enrollment should be fairly easy,” she said. Enrollment in the trail will begin immediately after the AAO meeting.

Ioannis Pallikaris, MD, PhD, also at the press briefing, said he has found in previous studies that epi-LASIK creates minimal haze. “We are not killing the epithelium,” he said.