Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: WaveLight UV-Femtosecond
Laser System, Model 1026
(UV-FS laser): Investigational ultraviolet femtosecond laser (UV fs-Laser) for providing refractive surgery: one corneal flap creation
Sponsors
Alcon Laboratories Inc
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference between achieved average central corneal flap thickness and intended flap thickness.Timepoint: At 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum deviation of average central flap thickness from flap thickness at the margins 2. Ease of flap lift assessed on 0-5 scale 3. Deviation of actual corneal flap diameter 4. Quality of corneal flap at the marginTimepoint: 1. At 1 month 2. At the surgery Visit 3. At the surgery visit 4. At the surgery visit | — |
Countries
Germany, India, Turkey
Contacts
Public ContactDr Arindam Dey
Alcon laboratories India Pvt Ltd
Outcome results
None listed