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NCT07127757Recruiting

Clinical Evaluation of WaveLight Plus LASIK

Laser Defined Vision

Start Date

8/28/2025

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 Low Luminance Questionnaire (LLQ-32) Questionnaire.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Subject must be able to understand and sign an IRB approved Informed consent form * Willing and able to attend all scheduled study visits as required per protocol * Minimum of 18 years of age * Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction * Best corrected photopic distance visual acuity of 20/20-2 or better (≤ 0.04 logMAR) * Mesopic pupil size ≥ 4.5mm * Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction * Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history * If currently wearing contact lenses: * Soft CTL wearers discontinue for minimum 3 days prior to first refraction * RGP or toric soft CTL wearers discontinue for ≥2 weeks prior to first refraction Exclusion Criteria: * Subjects who are pregnant or nursing * Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study * Patients with flap complications * Systemic medications that may confound the outcome of the study or increase the risk to the subject. * Ocular condition (other than high myopia) that may predispose the subject to future complications, such as ectasia * History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy) * Evidence of retinal vascular disease * Keratoconus or Keratoconus suspect * Glaucoma or glaucoma suspect by exam findings and/or family history * Previous intraocular or corneal surgery * Predicted residual stromal bed thickness \< 250 μm * Intended to have monovision treatment * Participation in other current clinical trials

Interventions

DEVICE

Wavelight Plus LASIK

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Conditions

MyopiaAstigmatism

Locations

Laser Defined Vision

Greensboro, North Carolina 27401

United States