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Patient Reported Outcomes With WaveLight Plus LASIK

Patient Reported Outcomes With WaveLight Plus LASIK

Recruiting
18-39 years
All
Phase N/A

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Overview

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

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

Study details
    Myopia
    Astigmatism

NCT07084844

Mann Eye Institute

15 October 2025

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