Patient Reported Outcomes With WaveLight Plus LASIK

NCT ID: NCT07087665

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-24
• Study Completion Date: 2026-09-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Wavelight Plus

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

OVO LASIK + Lens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark C Lobanoff, MD

Role: PRINCIPAL_INVESTIGATOR

OVO LASIK + Lens

Locations

Ovo Lasik + Lens

Saint Louis Park, Minnesota, United States

Countries

United States

Other Identifiers

ML-25-01

Identifier Type: -

Identifier Source: org_study_id