One-year results from the phase III investigation of the KeraVision Intacs.

ABSTRACT

BACKGROUND: Limitations of the surgical correction for myopia include inaccuracy, instability, treatment of the central optical zone, and lack of reversibility. KeraVision Intacs offer an alternative that addresses these shortcomings. METHODS: We present 1 year of follow-up information on 95 subjects enrolled in the United States Food and Drug Administration Phase III clinical trials. RESULTS: At 1 year, 99% of patients (89 of 90) had 20/40 uncorrected vision or better. Ninety-two percent of eyes (83 of 90) were within 1.00 D of intended correction and 76% of eyes (68 of 90) were within 0.50 D of intended correction. Stability was achieved at 3 months, with 96% of subjects (86 of 90) having less than 1.00 D of change from their previous examination. In a substudy, 89% eyes (58 of 65) varied within +/- 0.50 D over the course of a day. Corneal curvature changed as predicted, resulting in a prolate aspheric shape within the central optical zone. Most complications or adverse events experienced were managed with additional medication or surgical intervention, resulting in a favorable outcome for subjects. CONCLUSIONS: KeraVision Intacs are effective, predictable, stable, and safe. This additive technique may also offer reversibility.