Patient Reported Outcomes With WaveLight Plus LASIK
Recruiting now
Conditions studied: Myopia, Astigmatism
In brief
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.
Key facts
- Study ID
- NCT07084844
- Run by
- Mann Eye Institute
- People needed
- 52
- Starts
- 2025-09-05
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-09-15
Who can join
Age: 18 and older, up to 39. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mann Eye Institute — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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