Patient Reported Outcomes With WaveLight LASIK
Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK
1 other identifier
observational
300
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2025
CompletedResults Posted
Study results publicly available
March 23, 2026
CompletedMarch 23, 2026
March 1, 2026
4 months
October 30, 2024
February 25, 2026
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction
Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).
12 months postoperatively
Secondary Outcomes (3)
PROWL Questionnaire
12 months postoperatively
OSDI Questionnaire
12 months postoperatively
Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.
12 months postoperatively
Interventions
Phorcidies Planned Contoura LASIK
Eligibility Criteria
Eligible test subjects will be 21 to 35 years of age (at the time of surgery) and who underwent Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months prior.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OVO LASIK + Lenslead
- Sengicollaborator
Study Sites (4)
NVISION Eye Centers
San Diego, California, 92130, United States
Boston Vision
Brookline, Massachusetts, 02445, United States
Ovo Lasik + Lens
Saint Louis Park, Minnesota, 55416, United States
Mann Eye Institute
Houston, Texas, 76134-2099, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark C. Lobanoff
- Organization
- OVO Lasik and Lens LLC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
November 1, 2024
Study Start
November 1, 2024
Primary Completion
February 14, 2025
Study Completion
February 14, 2025
Last Updated
March 23, 2026
Results First Posted
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share