N/A
N=300
Patient Reported Outcomes With WaveLight LASIK
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT06668909 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Patient Satisfaction — 285 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- WaveLight® EX500 (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- OVO LASIK + Lens
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Satisfaction |
285 | — |
| SECONDARY PROWL Questionnaire |
3; 18; 12; 33 | — |
| SECONDARY OSDI Questionnaire |
8.7 | — |
| SECONDARY Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication. |
12 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06668909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.