The Epi-K disposable epikeratome from Moria for Epi-LASIK has been approved for marketing.
The Epi-K is utilized to mechanically separate the epithelium from Bowman's membrane. The epithelial flap is then folded back prior to laser ablation, and subsequently returned to its original position. The procedure preserves the structural integrity of the stroma and is expected to minimize discomfort, shorten the length of visual recovery, and reduce the incidence of haze associated with other surface ablation procedures, such as PRK and LASEK.
In rigorous clinical trials at 13 sites in nine countries on over 500 eyes, the Epi-K achieved excellent results. All clinical investigators reported that the device produced very high quality epithelial flaps and that postoperative pain and visual recovery compared favorably with other surface ablation procedures. Dr. Barrie Soloway, principal investigator at one of the US sites, noted that 88% of patients indicated they could return to work within three days following surgery.
Moria plans to begin filling orders for the Epi-K in late April.