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Patient Reported Outcomes With WaveLight Plus LASIK | Clinical Trials | Clareo Health

RECRUITING

Patient Reported Outcomes With WaveLight Plus LASIK

Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK

NCT07084844•Mann Eye Institute

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

Age

18 - 39 years

Sex

ALL

Healthy Volunteers

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)
+3 more criteria

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

Locations (1)

Mann Eye Institute

Houston, Texas, United States

Key Dates

Start Date

September 5, 2025

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

September 15, 2025

Enrollment

ESTIMATED participants

Conditions

MyopiaAstigmatism

Interventions

WaveLigh Plus LASIK

DEVICE

Contacts

Study Coordinator

CONTACT

713-580-2500 Melissa.Wright@manneye.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Patient Reported Outcomes With WaveLight Plus LASIK

Inclusion Criteria

Exclusion Criteria

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