Patient Reported Outcomes With WaveLight LASIK

Last updated: March 19, 2025
Sponsor: OVO LASIK + Lens
Overall Status: Completed

Phase

N/A

Condition

Myopia

Treatment

WaveLight® EX500

Clinical Study ID

NCT06668909
ML-24-01
  • Ages 21-35
  • All Genders

Study Summary

This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopicastigmatism 12 to 15 months ago

  • Age: 21 to 35 years of age at the time of surgery.

  • Preoperative myopic sphere of -1.00 D to -8.00 D

  • Preoperative regular astigmatism of 0.00 D to -3.00 D.

  • Stable refraction preoperatively defined as < 0.5 D of change over at least 1 year.

  • Refractive target of bilateral emmetropia.

Exclusion

Exclusion Criteria:

  • Corneal ectatic disorders.

  • Patients with a calculated residual stromal depth of < 300 um.

  • Pre-existing retinal or corneal pathology, or irregular astigmatism.

  • Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.

  • Previous corneal surgeries prior to LASIK.

  • LASIK enhancements.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: WaveLight® EX500
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
February 14, 2025

Connect with a study center

  • NVISION Eye Centers

    San Diego, California 92130
    United States

    Site Not Available

  • Boston Vision

    Brookline, Massachusetts 02445
    United States

    Site Not Available

  • Ovo Lasik + Lens

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Mann Eye Institute

    Houston, Texas 76134-2099
    United States

    Site Not Available

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