Patient Reported Outcomes With WaveLight Plus LASIK

Completed

Conditions studied: Myopia

In brief

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 facts

Study ID

NCT07087665

Run by

OVO LASIK + Lens

People needed

60

Starts

2025-07-24

Expected to finish

2026-05-18

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 37. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be able to understand and sign an approved consent form.
• Willing and able to comply with scheduled visits and other study procedures.
• Age: 18 to 37
• Myopia with or without astigmatism and MRSE within the range indications for wavelight plus (myopia up to -8 D, astigmatism up to -3.0 D, S.E. more than -1.00 and up to -9.00D)
• Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.
• Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery.
• Refractive target of bilateral emmetropia
• Mesopic pupil size ≥ 4.5mm
• Less than 0.75 D spherical equivalent difference between Sightmap measured refraction SE and the subjective manifest refraction (MRSE)

You may not qualify if…

• Subjects with a history of previous ocular surgery.
• Subjects with topographic evidence of keratoconus or ectasia.
• Pre-existing retinal or corneal pathology 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 uncontrolled dry eye) in which the investigator's opinion would affect the outcome of refractive surgery.
• Patients with a calculated residual stromal depth <250 µm would be excluded from the study.

Where it is running

• Ovo Lasik + Lens — Saint Louis Park, Minnesota, United States

Full record on ClinicalTrials.gov

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