Clinical Investigation of the WaveLight® UV Femtosecond Laser for Corneal Flap Creatio

Not Applicable

• Conditions: H52.1; Myopia

• Registration Number: DRKS00031772
• Lead Sponsor: Alcon Research, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-22
• Study Completion: 2024-02-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Subjects of either sex who are at least 18 years of age or older, with
good ocular health, natural lens with no evidence of cataract, who
meet minimum requirements for ECD, are eligible for

Exclusion Criteria

Subjects with contraindicated systemic disease or ocular conditions,
including dry eye, treatment with a contraindicated medication, or
with predicted postoperative stromal bed thickness.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean difference between achieved average central corneal flap thickness and intended flap thickness at 1 month

Secondary Outcome Measures

Name	Time	Method
1. Maximum deviation of average central flap<br>thickness from flap thickness at the margins at 1 month<br>2. Ease of flap lift assessed on 0-5 scale at the surgery visit<br>3. Deviation of actual corneal flap diameter at the surgery visit<br>4. Quality of corneal flap at the margin at the surgery visit