Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: WaveLight® Ultraviolet Femtosecond Laser System, Model 1026
(UV fs-Laser) with accompanying Patient Interface, Model 1507: Preparation of the subject for surgery involves the use of a p
Sponsors
Alcon Laboratories Inc
Alcon Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants will include male and female subjects 18 years of age or older, with good ocular health, diagnosed with myopia in the study eye with manifest refraction sphere of -0.50 to -10.0 D and cylinder < -0.5 D. Subjects must have no evidence of cataract or prior ocular surgeries in the study eye.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if the eye to be treated is unable to focus for imaging and/or treatment, has a predicted residual stromal bed thickness <250 µm, or if the subject has any acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study or are using any contraindicated medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate achieved spherical manifest refraction at post operative follow up visits.Timepoint: Day 01 Week 01 Month 01 month 03 Month 06 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cylinder manifest refraction, UCDVA and MRSE at postoperative follow-up visitsTimepoint: Day 01 Week 01 Month 01 month 03 Month 06 | — |
Countries
Australia, Germany, India
Contacts
Public ContactDr. Arindam Dey
Alcon laboratories India Pvt Ltd
Outcome results
None listed