NCT07084844 Patient Reported Outcomes With WaveLight Plus LASIK
| NCT ID | NCT07084844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mann Eye Institute |
| Condition | Myopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 52 participants in total. It began in 2025-09-05 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Phillip Brunson
PRINCIPAL INVESTIGATOR
Mann Eye Institute
Frequently Asked Questions
Who can join the NCT07084844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 39 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07084844 currently recruiting?
Yes, NCT07084844 is actively recruiting participants. Contact the research team at Melissa.Wright@manneye.com for enrollment information.
Where is the NCT07084844 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07084844 clinical trial?
NCT07084844 is sponsored by Mann Eye Institute. The principal investigator is Phillip Brunson at Mann Eye Institute. The trial plans to enroll 52 participants.