Patient Reported Outcomes With WaveLight Plus LASIK

NCT07087665 | Enrolling By Invitation FDA Device

• 1 other identifier: ML-25-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only).

  6 months postoperatively

Secondary Outcomes (3)

• Remaining Vision quality and quality of life during daily tasks using the adapted PROWL

  6 months postoperatively

• The percentage of eyes at each monocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25).

  6 months postoperatively

• The percentage of subjects at each binocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25).

  6 months postoperatively

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.

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be 18 to 37 years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism.

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.

Sponsors & Collaborators

• OVO LASIK + Lens: lead
• Sengi: collaborator

Study Sites (1)

Ovo Lasik + Lens

Saint Louis Park, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Mark C Lobanoff, MD

  OVO LASIK + Lens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 28, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (1)