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NCT07084844Recruiting

Patient Reported Outcomes With WaveLight Plus LASIK

Mann Eye Institute

Start Date

9/5/2025

Completion Date

9/1/2026

Summary

This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.

Eligibility Criteria

Age Range: 18 years to 39 years

Inclusion Criteria: * Between the ages of 18 and 39 * Meet the standard care requirements for LASIK * Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters * Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism * SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D * Minimum residual stromal bed thickness of 250 µm * If currently wearing contact lenses: * Soft CTL wearers discontinue for minimum 3 days * RGP CTL wearers discontinue for 1 month per decade of wear * Stable refraction (2 consecutive manifest refractions within 0.25 SE) * Stable K readings (2 consecutive K readings in 2 consecutive visits) * Willing and able to complete all post-operative visits * Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm Exclusion Criteria: * Subjects with any prior ocular surgery * Subjects with topographic evidence of keratoconus, or ectasia * Subjects with autoimmune diseases * Subjects who are pregnant or nursing * Systemic disease likely to affect wound healing, such as diabetes and severe atopy * Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery

Interventions

DEVICE

WaveLigh Plus LASIK

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Conditions

MyopiaAstigmatism

Locations

Mann Eye Institute

Houston, Texas 77004

United States