Patient Reported Outcomes With WaveLight Plus LASIK
Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK
Mann Eye Institute
52 participants
Sep 5, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria13
- 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 Criteria6
- 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
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Interventions
Wavelight plus LASIK is an advanced laser eye surgery technology designed to enhance visual outcomes through personalized treatment plans. This system integrates comprehensive diagnostics, including biometry, tomography, and wavefront measurements, to create a tailored ablation profile for each patient.
Locations(1)
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NCT07084844