Patient Reported Outcomes With WaveLight Plus LASIK (NCT07087665) | Clinical Trial Compass
CompletedNot Applicable
Patient Reported Outcomes With WaveLight Plus LASIK
United States60 participantsStarted 2025-07-24
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 6 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL, QIRC, and OSDI questionnaires.
Who can participate
Age range
18 Years – 37 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:
* Subject must be able to understand and sign an approved consent form.
* Willing and able to comply with scheduled visits and other study procedures.
* Age: 18 to 37
* Myopia with or without astigmatism and MRSE within the range indications for wavelight plus (myopia up to -8 D, astigmatism up to -3.0 D, S.E. more than -1.00 and up to -9.00D)
* Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.
* Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery.
* Refractive target of bilateral emmetropia
* Mesopic pupil size ≥ 4.5mm
* Less than 0.75 D spherical equivalent difference between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)
Exclusion Criteria:
* Subjects with a history of previous ocular surgery.
* Subjects with topographic evidence of keratoconus or ectasia.
* Pre-existing retinal or corneal pathology 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 uncontrolled dry eye) in which the investigator's opinion would affect the outcome of refractive surgery.
* Patients with a calculated residual stromal depth \<250 µm would be excluded from the study.
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
Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only).