Patient Reported Outcomes With WaveLight LASIK

OVO LASIK + Lens

Status: Completed

Conditions: Myopia

Treatments: Device: WaveLight® EX500

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06668909

ML-24-01

Details and patient eligibility

About

This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.

Enrollment: 300 patients

Sex: All

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago
• Age: 21 to 35 years of age at the time of surgery.
• Preoperative myopic sphere of -1.00 D to -8.00 D
• Preoperative regular astigmatism of 0.00 D to -3.00 D.
• Stable refraction preoperatively defined as < 0.5 D of change over at least 1 year.
• Refractive target of bilateral emmetropia.

Exclusion criteria

• Corneal ectatic disorders.
• Patients with a calculated residual stromal depth of < 300 um.
• Pre-existing retinal or corneal pathology, or irregular astigmatism.
• Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc.
• Previous corneal surgeries prior to LASIK.
• LASIK enhancements.