Patient Reported Outcomes With WaveLight Plus LASIK (NCT07084844) | Clinical Trial Compass
RecruitingNot Applicable
Patient Reported Outcomes With WaveLight Plus LASIK
United States52 participantsStarted 2025-09-05
Plain-language 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.
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only).