Patient Reported Outcomes With WaveLight LASIK

Completed

• Conditions: Myopia

• Registration Number: NCT06668909
• Lead Sponsor: OVO LASIK + Lens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study Start: 2024-11-01
• Study First Posted: 2024-11-01
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	12 months postoperatively	Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only).

Secondary Outcome Measures

Name	Time	Method
OSDI Questionnaire	12 months postoperatively	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.
Percentage of subjects using artificial tears or prescription dry eye medication.	12 months postoperatively
PROWL Questionnaire	12 months postoperatively	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.

Trial Locations

Locations (4)

NVISION Eye Centers; 🇺🇸 San Diego, California, United States

Boston Vision; 🇺🇸 Brookline, Massachusetts, United States

Ovo Lasik + Lens; 🇺🇸 Saint Louis Park, Minnesota, United States

Mann Eye Institute; 🇺🇸 Houston, Texas, United States