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J Am Optom Assoc. 1999 Aug;70(8):515-24.

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

Author information

  • 1Shiley Eye Center, University of California-San Diego, La Jolla, USA.

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.

PMID:
10506815
[PubMed - indexed for MEDLINE]
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