Patient Reported Outcomes With WaveLight Plus LASIK

OVO LASIK + Lens

Status: Invitation-only

Conditions: Myopia

Treatments: Device: Wavelight Plus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07087665

ML-25-01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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.