Actively Recruiting
Patient Reported Outcomes With WaveLight Plus LASIK
Led by Mann Eye Institute · Updated on 2025-09-15
52
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
M
Mann Eye Institute
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Patient Reported Outcomes With WaveLight Plus LASIK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 b5m
- Soft contact lens wearers must discontinue use for at least 3 days
- Rigid gas permeable contact lens wearers must discontinue use for 1 month per decade of wear
- Stable refraction with 2 consecutive manifest refractions within 0.25 SE
- Stable keratometry readings with 2 consecutive readings in 2 visits
- Willing and able to complete all post-operative visits
- Pre-surgery best corrected distance visual acuity (BCDVA) of 20/20 (0.00 logMAR) or better in each eye
- Mesopic pupil size e 4.5mm
You will not qualify if you...
- Prior ocular surgery
- Topographic evidence of keratoconus or ectasia
- Autoimmune diseases
- Pregnant or nursing
- Systemic diseases likely to affect wound healing, such as diabetes and severe atopy
- Any ocular disease, including uncontrolled dry eye, that could affect refractive surgery outcomes in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mann Eye Institute
Houston, Texas, United States, 77004
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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