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Patient Reported Outcomes With WaveLight Plus LASIK
Sponsor: OVO LASIK + Lens
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.
Official title: Patient Satisfaction, Quality of Vision, and Quality of Life Following Treatment With WaveLight Plus LASIK
Key Details
Gender
All
Age Range
18 Years - 37 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2025-07-24
Completion Date
2026-09-01
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
Wavelight Plus
The WaveLight EX500 laser system, in conjunction with INNOVEYES Sightmap, is indicated for use in INNOVEYES Laser Assisted In-Situ Keratomileusis ("wavelight plus"1 LASIK) treatments: * or the reduction or elimination of myopia or myopia with astigmatism, in eyes with spherical equivalent (SE) more than -1.00 and up to -9.00 diopters (D), with up to -8.00 D of spherical component (in minus cylinder format) and up to -3.00 D of astigmatic component at the spectacle plane, based on the INNOVEYES Sightmap Measured Refraction, * in patients with magnitude of the spherical equivalent (SE) difference between the Manifest Refraction (MRSE) and the Sightmap measured refraction SE being less than 0.75D, * in patients who are 18 years of age or older, and * for patients with documentation of a stable manifest refraction defined as 0.5 D preoperative spherical equivalent shift over one year prior to surgery.
Locations (1)
Ovo Lasik + Lens
Saint Louis Park, Minnesota, United States