Journal of refractive surgery (Thorofare, N.J. : 1995) · 2025
Clinical Evaluation of the Stationary Scanning-Spot EX500 Excimer Laser System for Hyperopic LASIK in Patients With Hyperopia With and Without Astigmatism.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Stonecipher Karl, Stahl Jason, Greenwood Michael, Moyes Andrew, Mann Paul
Аннотация
PURPOSE: To collect additional safety and efficacy data in patients with and without astigmatism requiring hyperopic correction with planned bilateral laser in situ keratomileusis (LASIK) treatment using the WaveLight EX500 excimer laser (Alcon Laboratories, Inc).
METHODS: This was a prospective, single-arm, multicenter, interventional study of 60 eyes requiring refractive correction of hyperopia of +3.00 diopters (D) of sphere or less with or without astigmatism. Primary effectiveness endpoints were manifest refraction spherical equivalent (MRSE) within ±0.50 D at refractive stability (target > 50%) and within ±1.00 D at refractive stability (target > 75%). The primary safety endpoint was ocular adverse events.
RESULTS: With refractive stability established at 3 months postoperatively, MRSE within ±0.50 D of the intended target was achieved in more than 98% of eyes (> 96% at 12 months), manifest refraction sphere within ±0.50 D of target in 95% of eyes (> 98% at 12 months), and residual refractive cylinder of 0.50 D or less in 93% of eyes (100% at 12 months). No eyes had overcorrection or undercorrection of MRSE by greater than 1.00 D at refractive stability and subsequent time points. Postoperative manifest refraction sphere and residual manifest refraction cylinder were within ±1.00 D in 100% of eyes at 12 months. Safety and patient-reported findings were consistent with previous reports, with high safety profiles.
CONCLUSIONS: The WaveLight EX500 excimer laser system was safe and effective for LASIK treatment of hyperopia with or without astigmatic refractive errors. [J Refract Surg. 2025;41(7):e655-e661.].
METHODS: This was a prospective, single-arm, multicenter, interventional study of 60 eyes requiring refractive correction of hyperopia of +3.00 diopters (D) of sphere or less with or without astigmatism. Primary effectiveness endpoints were manifest refraction spherical equivalent (MRSE) within ±0.50 D at refractive stability (target > 50%) and within ±1.00 D at refractive stability (target > 75%). The primary safety endpoint was ocular adverse events.
RESULTS: With refractive stability established at 3 months postoperatively, MRSE within ±0.50 D of the intended target was achieved in more than 98% of eyes (> 96% at 12 months), manifest refraction sphere within ±0.50 D of target in 95% of eyes (> 98% at 12 months), and residual refractive cylinder of 0.50 D or less in 93% of eyes (100% at 12 months). No eyes had overcorrection or undercorrection of MRSE by greater than 1.00 D at refractive stability and subsequent time points. Postoperative manifest refraction sphere and residual manifest refraction cylinder were within ±1.00 D in 100% of eyes at 12 months. Safety and patient-reported findings were consistent with previous reports, with high safety profiles.
CONCLUSIONS: The WaveLight EX500 excimer laser system was safe and effective for LASIK treatment of hyperopia with or without astigmatic refractive errors. [J Refract Surg. 2025;41(7):e655-e661.].