Investigation of laser for eye treatment
Not Applicable
Completed
- Conditions
- Health Condition 1: H521- Myopia
- Registration Number
- CTRI/2022/06/043607
- Lead Sponsor
- Alcon Laboratories Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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
LASIK, and have stable refraction (as determined by defined MRSE criteria) with sphere of -1.00 to -8.0 D and cylinder < 3.0 D in the study eye are eligible to participate in the study.
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.Timepoint: At 1 month
- Secondary Outcome Measures
Name Time Method 1. Maximum deviation of average central flap thickness from flap thickness at the margins <br/ ><br>2. Ease of flap lift assessed on 0-5 scale <br/ ><br>3. Deviation of actual corneal flap diameter <br/ ><br>4. Quality of corneal flap at the marginTimepoint: 1. At 1 month <br/ ><br>2. At the surgery Visit <br/ ><br>3. At the surgery visit <br/ ><br>4. At the surgery visit