Karl Stonecipher, Jason Stahl, Michael Greenwood, Andrew Moyes, Paul Mann
{"title":"固定扫描点EX500准分子激光系统治疗伴散光远视和不伴散光远视LASIK的临床评价","authors":"Karl Stonecipher, Jason Stahl, Michael Greenwood, Andrew Moyes, Paul Mann","doi":"10.3928/1081597X-20250520-04","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The WaveLight EX500 excimer laser system was safe and effective for LASIK treatment of hyperopia with or without astigmatic refractive errors. <b>[<i>J Refract Surg</i>. 2025;41(7):e655-e661.]</b>.</p>","PeriodicalId":16951,"journal":{"name":"Journal of refractive surgery","volume":"41 7","pages":"e655-e661"},"PeriodicalIF":3.0000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical Evaluation of the Stationary Scanning-Spot EX500 Excimer Laser System for Hyperopic LASIK in Patients With Hyperopia With and Without Astigmatism.\",\"authors\":\"Karl Stonecipher, Jason Stahl, Michael Greenwood, Andrew Moyes, Paul Mann\",\"doi\":\"10.3928/1081597X-20250520-04\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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. 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Clinical Evaluation of the Stationary Scanning-Spot EX500 Excimer Laser System for Hyperopic LASIK in Patients With Hyperopia With and Without Astigmatism.
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.].
期刊介绍:
The Journal of Refractive Surgery, the official journal of the International Society of Refractive Surgery, a partner of the American Academy of Ophthalmology, has been a monthly peer-reviewed forum for original research, review, and evaluation of refractive and lens-based surgical procedures for more than 30 years. Practical, clinically valuable articles provide readers with the most up-to-date information regarding advances in the field of refractive surgery. Begin to explore the Journal and all of its great benefits such as:
• Columns including “Translational Science,” “Surgical Techniques,” and “Biomechanics”
• Supplemental videos and materials available for many articles
• Access to current articles, as well as several years of archived content
• Articles posted online just 2 months after acceptance.