Health Condition 1: H522- Astigmatism
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 patien
Sponsors
Alcon Laboratories Inc
Alcon Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Myopia with sphere of -0.50 to -10.0 diopter and cylinder -0.25 to -2.0 diopter in study eye. Stable refraction in the study eye. Nondominant eye must qualify for treatment. BCDVA better or Equal 0.14 logMAR in study and fellow eyes UCDVA Worse or equal 0.30 logMAR in study eye Presence of clear natural lens (non-cataractous eye) in study eye. Minimum required endothelial cell density in study eye within defined age ranges.
Exclusion criteria
Exclusion criteria: Study eye unable to focus for imaging and or treatment. Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study. Current use of medications with known ocular side effects and photosensitivity. Ocular conditions in the either eye that may affect subject safety or impact study outcomes. Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Astigmatism subjective (manifest dry) manifest refraction at postoperative follow-up visits [Time Frame: Week 1, Month 1, Month 3, Month 6] 2. Best Corrected Distance Visual Acuity (BCDVA) at postoperative follow-up visits [Time Frame: Week 1, Month 1, Month 3, Month 6] 3. Ocular Serious Adverse EventsTimepoint: 1. Week 1, Month 1, Month 3, Month 06 2. Week 1, Month 1, Month 3, Month 06 3. From time of consent to study exit (cumulative to Month 6 postoperative) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Spherical subjective (manifest dry) refraction at postoperative follow-up visits 2. Uncorrected Distance Visual Acuity at all postoperative follow-up visits 3. Manifest Refraction Spherical Equivalent (MRSE) at postoperative follow-up visits Timepoint: 1. Week 1, Month 1, Month 3, Month 06 2. Day 1, Week 1, Month 1, Month 3, Month 6 3. Week 1, Month 1, Month 3, Month 6 | — |
Countries
Australia, Germany, Greece, India
Contacts
Public ContactPavan Kumar
Alcon laboratories India Pvt Ltd
Outcome results
None listed