Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: WaveLight UV-Femtosecond Laser System, Model 1026 (UV-FS laser): Refractive correction for myopia (using a UV-FS laser to create an intrastromal Lenticule in the cornea which is then ex
Sponsors
Alcon laboratories India pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - Subject must be able to understand and sign an IRB/IEC approved Informed Consent form. - Willing and able to attend all scheduled study visits as required per protocol - Myopia with sphere of -0.50 to -10.0 D cylinder - Other protocol defined inclusion criteria may apply
Exclusion criteria
Exclusion criteria: - Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply: a. they are currently pregnant, b. have a positive UPT result at Screening, c. intend to become pregnant during the study period, d. are breast-feeding. Subjects who become pregnant during the study will not be discontinued; however, data will be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results - 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 as clinically assessed by the Investigator (including history of Herpes Simplex) - Current use of medications with known ocular side effects and photosensitivity, including but not limited to: steroids, antimetabolites, Isotretinoin (Accutane®), Amiodarone hydrochloride (Cordarone),or Hydroxychloroquine (Plaquenil), Tetracyclincs, Nalidixic Acids, and Fluoroquinolones - Other protocol specified exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Extraction of lenticule (-0.5 to -10.0 D) 2. Presence of optical treatment zone corneal haze (slit-lamp examination) 3. Change in ECD between pre-op and post-op 4. Presence of Lens Opacification (slit-lamp examination) 5. Presence of disruption in the integrity of retinal layers (OCT) Timepoint: 1. At Surgery visit 2. At 1 month and 6 months 3. At 1 month and 6 months 4. At 1 month and 6 months 5. At 1 month and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India, Turkey
Contacts
Public ContactDr Arindam Dey
Alcon Laboratories India Pvt Ltd
Outcome results
None listed