Patient Reported Outcomes With WaveLight Plus LASIK

Part of paid clinical trials in Saint Louis Park, Minnesota.

Sponsor
OVO LASIK + Lens
Study ID
NCT07087665
Status
Enrolling By Invitation

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
18 Years - 37 Years
Healthy Volunteers
Not accepted

Interventions

  • Wavelight Plus — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 24, 2025
Status verified
Jul 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
60 participants (estimated)

Primary Outcome Measure

Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only). [ Time Frame: 6 months postoperatively ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ovo Lasik + LensSaint Louis ParkMinnesota55416-

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