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This article was originally published in The Gray Sheet

Executive Summary

Patient enrollment begins for a 400-eye, Phase III study to be used to support an eventual premarket approval application submission for its Refractec corneal shaping system that uses radiofrequency energy. Potential applications for the $40,000 device include low hyperopia, presbyopia and overcorrections by excimer laser treatment. Data released March 15 from a 65-eye Phase II study of the device in hyperopic patients shows the non-laser system achieved uncorrected visual acuity of 20/40 or better for the entire cohort 12 months post-operatively. All treated eyes had best corrected visual acuity of 20/25 or better, the Laguna Hills, California firm says. Patients treated in the study had +1 to +4.5 diopters of hyperopia, and 100% were within 1 diopter of the attempted correction at 12 months

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