Clinical Evaluation of WaveLight Plus LASIK
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
| Condition(s) | Myopia, Astigmatism |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 record |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Laser Defined Vision |
| Locations | Greensboro, North Carolina, United States |
| Start date | 2025-08-28 |
| NCT ID | NCT07127757 |
| Official listing | https://clinicaltrials.gov/study/NCT07127757 |