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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
Wavefront-guided laser in situ keratomileusis using the WaveScan system for correction of low to moderate myopia with astigmatism: 6-month results in 277 eyes.
Journal of Cataract and Refractive Surgery 2005 August
PURPOSE: To assess the safety and effectiveness of wavefront guided LASIK surgery using the Visx WaveScan system for correction of low to moderate myopia with astigmatism.
SETTING: Multicenter study at 6 sites in the United States.
METHODS: In this prospective nonrandomized clinical trial, treatments were performed at 6 sites in the United States using the WaveScan (CustomVue) guided excimer laser. A total of 351 eyes were enrolled, and 277 eyes were analyzed at 6 months.
RESULTS: At 6 months, 94% of eyes achieved an uncorrected visual acuity (UCVA) of 20/20 or better and 74% achieved a UCVA of 20/16 or better. Sixty-nine percent of eyes had the same or better postoperative UCVA than their preoperative best spectacle-corrected visual acuity (BSCVA). Ninety percent of eyes were within +/-0.5 diopter of intended correction. No eye lost more than 1 line of BSCVA. Total higher-order root-mean square (RMS), coma, and spherical aberration values were stable (P<.05).
CONCLUSION: The data support the safety and effectiveness of the WaveScan-guided customized laser ablation using the Visx Star S4 system for correction of low to moderate myopia with astigmatism.
SETTING: Multicenter study at 6 sites in the United States.
METHODS: In this prospective nonrandomized clinical trial, treatments were performed at 6 sites in the United States using the WaveScan (CustomVue) guided excimer laser. A total of 351 eyes were enrolled, and 277 eyes were analyzed at 6 months.
RESULTS: At 6 months, 94% of eyes achieved an uncorrected visual acuity (UCVA) of 20/20 or better and 74% achieved a UCVA of 20/16 or better. Sixty-nine percent of eyes had the same or better postoperative UCVA than their preoperative best spectacle-corrected visual acuity (BSCVA). Ninety percent of eyes were within +/-0.5 diopter of intended correction. No eye lost more than 1 line of BSCVA. Total higher-order root-mean square (RMS), coma, and spherical aberration values were stable (P<.05).
CONCLUSION: The data support the safety and effectiveness of the WaveScan-guided customized laser ablation using the Visx Star S4 system for correction of low to moderate myopia with astigmatism.
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