James J Salz1, Christy A Stevens. 1. American Eye Institute, Los Angeles, California. Alcon Surgical, Orlando, Florida 32826, USA.
Abstract
OBJECTIVE: To assess the safety and effectiveness of the LADARVision active tracking narrow beam excimer laser system (Alcon Surgical, Orlando, FL) using laser in situ keratomileusis (LASIK) for correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism. DESIGN: A multicenter, prospective non-randomized (self-controlled) comparative trial. PARTICIPANTS: A total of 360 eyes, including 152 spherical hyperopic, 143 hyperopic astigmatic, and 65 mixed astigmatic, were treated for up to +6.00-diopter (D) sphere with up to -6.00-D cylinder. INTERVENTION: Treatments were performed at six sites in the United States using a 6-mm optic zone with a 1.5-mm peripheral blend zone for a maximum ablation zone diameter of 9 mm. MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), manifest refraction, vector analysis, best spectacle-corrected visual acuity (BSCVA), complications and adverse reactions, subjective symptoms, and patient satisfaction. RESULTS: Six and 12 months of follow-up, respectively, were available on 143 and 117 spherical hyperopic eyes, 124 and 74 hyperopic astigmatic eyes, and 57 and 38 mixed astigmatic eyes, respectively. For spherical hyperopes at 6 and 12 months, UCVA was 20/40 or better in 93.4% and 93.9% of eyes, respectively. The manifest refraction spherical equivalent (MRSE) was within 0.50 D of intended in 65.0% and 74.1% of eyes, respectively, and within 1.00 D in 87.4% and 91.4%, respectively. Refractive stability was demonstrated in 94.2% or more of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 95.3% or more of eyes to 12 months. A loss of two lines of BSCVA occurred in 3.5% and 3.4%, respectively, and no eyes lost more than two lines. For hyperopic astigmats at 6 and 12 months, UCVA was 20/40 or better in 90.9% and 93.8% of eyes, respectively. The MRSE was within 0.50 D of intended in 60.5% and 73.0% of eyes, respectively, and within 1.00 D in 88.7% and 89.2% of eyes, respectively. Refractive stability was demonstrated in 96.5% or more of eyes, respectively, between the intervals of 1 to 3 months and 3 to 6 months and 95.5% or more to 12 months. A loss of two lines of BSCVA occurred in 5.8% and 1.4% of eyes, respectively, and no eyes lost more than two lines. For mixed astigmats at 6 and 12 months, UCVA was 20/40 or better in 92.6% and 94.4% of eyes, respectively. The MRSE was within 0.50 D of intended in 64.9% and 73.7% of eyes, respectively, and within 1.00 D in 87.7% and 94.7% of eyes, respectively. Refractive stability was demonstrated in 100% of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 97.0% or more to 12 months. A loss of two lines of BSCVA occurred in 1.9% and 0.0% of eyes, respectively, and no eyes lost more than two lines. CONCLUSIONS: The data support safety and effectiveness of the LASIK correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism with the LADARVision system.
OBJECTIVE: To assess the safety and effectiveness of the LADARVision active tracking narrow beam excimer laser system (Alcon Surgical, Orlando, FL) using laser in situ keratomileusis (LASIK) for correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism. DESIGN: A multicenter, prospective non-randomized (self-controlled) comparative trial. PARTICIPANTS: A total of 360 eyes, including 152 spherical hyperopic, 143 hyperopic astigmatic, and 65 mixed astigmatic, were treated for up to +6.00-diopter (D) sphere with up to -6.00-D cylinder. INTERVENTION: Treatments were performed at six sites in the United States using a 6-mm optic zone with a 1.5-mm peripheral blend zone for a maximum ablation zone diameter of 9 mm. MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), manifest refraction, vector analysis, best spectacle-corrected visual acuity (BSCVA), complications and adverse reactions, subjective symptoms, and patient satisfaction. RESULTS: Six and 12 months of follow-up, respectively, were available on 143 and 117 spherical hyperopic eyes, 124 and 74 hyperopic astigmatic eyes, and 57 and 38 mixed astigmatic eyes, respectively. For spherical hyperopes at 6 and 12 months, UCVA was 20/40 or better in 93.4% and 93.9% of eyes, respectively. The manifest refraction spherical equivalent (MRSE) was within 0.50 D of intended in 65.0% and 74.1% of eyes, respectively, and within 1.00 D in 87.4% and 91.4%, respectively. Refractive stability was demonstrated in 94.2% or more of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 95.3% or more of eyes to 12 months. A loss of two lines of BSCVA occurred in 3.5% and 3.4%, respectively, and no eyes lost more than two lines. For hyperopic astigmats at 6 and 12 months, UCVA was 20/40 or better in 90.9% and 93.8% of eyes, respectively. The MRSE was within 0.50 D of intended in 60.5% and 73.0% of eyes, respectively, and within 1.00 D in 88.7% and 89.2% of eyes, respectively. Refractive stability was demonstrated in 96.5% or more of eyes, respectively, between the intervals of 1 to 3 months and 3 to 6 months and 95.5% or more to 12 months. A loss of two lines of BSCVA occurred in 5.8% and 1.4% of eyes, respectively, and no eyes lost more than two lines. For mixed astigmats at 6 and 12 months, UCVA was 20/40 or better in 92.6% and 94.4% of eyes, respectively. The MRSE was within 0.50 D of intended in 64.9% and 73.7% of eyes, respectively, and within 1.00 D in 87.7% and 94.7% of eyes, respectively. Refractive stability was demonstrated in 100% of eyes between the intervals of 1 to 3 months and 3 to 6 months and in 97.0% or more to 12 months. A loss of two lines of BSCVA occurred in 1.9% and 0.0% of eyes, respectively, and no eyes lost more than two lines. CONCLUSIONS: The data support safety and effectiveness of the LASIK correction of spherical hyperopia, hyperopic astigmatism, and mixed astigmatism with the LADARVision system.