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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
Laser in situ keratomileusis for myopia up to -11 diopters with up to -5 diopters of astigmatism with the summit autonomous LADARVision excimer laser system.
Ophthalmology 2001 Februrary
OBJECTIVE: To assess the safety and effectiveness of the Summit Autonomous LADARVision active tracking narrow beam excimer laser system for laser in situ keratomileusis (LASIK) correction of myopia and astigmatism.
DESIGN: A multicenter, prospective noncomparative case series.
PARTICIPANTS: This cohort consisted of 177 eyes corrected for spherical myopia up to -11 diopters (D) and 170 eyes corrected for myopia up to -11 D spherical equivalent with astigmatism up to -5 D.
INTERVENTION: Treatments were performed at four sites in the United States using a 6-mm optic zone for spherical myopes and a 5.5-mm optic zone with a 1-mm blend for astigmats.
MAIN OUTCOME MEASURES: Visual acuity, subjective refraction, vector analysis, subject satisfaction, intraocular pressure, complications, and adverse reactions.
RESULTS: Six-month follow-up was available on 157 spherical eyes and 113 astigmatic eyes. For spherical myopes, uncorrected visual acuity (UCVA) was 20/20 or better in 60.5%, 20/25 or better in 80.3%, and 20/40 or better in 93.9%. The mean spherical equivalent was -0.29 +/- 0.45 D with 75.2% +/- 0.50 D and 94.9% +/- 1.00 D of intended. A loss of two lines of best spectacle-corrected visual acuity (BSCVA) occurred in 0.6%, and no eyes lost greater than two lines of BSCVA. For astigmatic myopes, UCVA was 20/20 or better in 52.0%, 20/25 or better in 74.5%, and 20/40 or better in 94.1%. The mean spherical equivalent was -0.23 +/- 0.49 D with 75.2% +/- 0.50 D and 95.6% +/- 1.00 D of intended. A loss of two lines of BSCVA occurred in 0.9%, and no eyes lost greater than two lines of BSCVA. Vector analysis showed that 99% of the intended cylinder was corrected on average with a mean angle of error of 4.2 degrees. Refractive stability was achieved between 1 and 3 months in 97.5% of spherical eyes and 99.4% of astigmatic eyes and confirmed between 3 and 6 months in 100% of both spherical and astigmatic eyes.
CONCLUSIONS: Eyes treated for myopia up to -11 D of spherical equivalent with or without astigmatism up to -5 D show early refractive stability, good UCVA outcomes, no significant loss of BSCVA, accurate correction of astigmatism, and slight undercorrection without a change from the photorefractive keratectomy algorithm and with a single treatment.
DESIGN: A multicenter, prospective noncomparative case series.
PARTICIPANTS: This cohort consisted of 177 eyes corrected for spherical myopia up to -11 diopters (D) and 170 eyes corrected for myopia up to -11 D spherical equivalent with astigmatism up to -5 D.
INTERVENTION: Treatments were performed at four sites in the United States using a 6-mm optic zone for spherical myopes and a 5.5-mm optic zone with a 1-mm blend for astigmats.
MAIN OUTCOME MEASURES: Visual acuity, subjective refraction, vector analysis, subject satisfaction, intraocular pressure, complications, and adverse reactions.
RESULTS: Six-month follow-up was available on 157 spherical eyes and 113 astigmatic eyes. For spherical myopes, uncorrected visual acuity (UCVA) was 20/20 or better in 60.5%, 20/25 or better in 80.3%, and 20/40 or better in 93.9%. The mean spherical equivalent was -0.29 +/- 0.45 D with 75.2% +/- 0.50 D and 94.9% +/- 1.00 D of intended. A loss of two lines of best spectacle-corrected visual acuity (BSCVA) occurred in 0.6%, and no eyes lost greater than two lines of BSCVA. For astigmatic myopes, UCVA was 20/20 or better in 52.0%, 20/25 or better in 74.5%, and 20/40 or better in 94.1%. The mean spherical equivalent was -0.23 +/- 0.49 D with 75.2% +/- 0.50 D and 95.6% +/- 1.00 D of intended. A loss of two lines of BSCVA occurred in 0.9%, and no eyes lost greater than two lines of BSCVA. Vector analysis showed that 99% of the intended cylinder was corrected on average with a mean angle of error of 4.2 degrees. Refractive stability was achieved between 1 and 3 months in 97.5% of spherical eyes and 99.4% of astigmatic eyes and confirmed between 3 and 6 months in 100% of both spherical and astigmatic eyes.
CONCLUSIONS: Eyes treated for myopia up to -11 D of spherical equivalent with or without astigmatism up to -5 D show early refractive stability, good UCVA outcomes, no significant loss of BSCVA, accurate correction of astigmatism, and slight undercorrection without a change from the photorefractive keratectomy algorithm and with a single treatment.
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