Patient Reported Outcomes With WaveLight LASIK

Patient Reported Outcomes on Vision Quality and Dry Eye Following Treatment With Wavelight LASIK

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: WaveLight® EX500

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92130
      • NVISION Eye Centers
  • Massachusetts
    • Brookline, Massachusetts, United States, 02445
      • Boston Vision
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Ovo Lasik + Lens
  • Texas
    • Houston, Texas, United States, 76134-2099
      • Mann Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROWL Questionnaire	PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question.	12 months postoperatively
OSDI Questionnaire	The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.	12 months postoperatively
Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication.		12 months postoperatively

Collaborators and Investigators

• Sponsor: OVO LASIK + Lens
• Collaborators: Sengi

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: ML-24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes