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document
One-year results from the phase III investigation of the KeraVision Intacs . 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 .
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Intervention_Physical
investigation of the KeraVision Intacs
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Intervention_Other
KeraVision Intacs
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Outcome_Other
Stability
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Outcome_Physical
Corneal curvature
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Outcome_Adverse-effects
complications or adverse events
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Outcome_Other
effective , predictable , stable , and safe
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Participant_Condition
myopia
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Participant_Sample-size
95
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Participant_Sample-size
89
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Participant_Sample-size
90
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Participant_Condition
20/40 uncorrected vision or better