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Clinical Evaluation of WaveLight Plus LASIK
Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Wavelight Plus LASIK (device)
Sponsor: Laser Defined Vision · Participants: 50 · Started: Aug 28, 2025
Contact the study team
- Carrie Williams · Phone: 336-288-8823
Official record on ClinicalTrials.gov — NCT07127757
Locations in the U.S.
| North Carolina | Laser Defined Vision, Greensboro |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.