Corneal Cross-Linking Comparing Variables
NCT02095730 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2014-03-26
Summary
The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.
Conditions
- Unstable Corneas
Interventions
- DRUG
-
Epithelium-On Riboflavin
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
- DRUG
-
Epithelium-Off Riboflavin
Riboflavin 0.1% Phosphate Sodium solution
- DEVICE
-
UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
- DEVICE
-
UV Pulsed Beam
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Sponsors & Collaborators
-
Crowd Health Research, LTD
lead OTHER
Principal Investigators
-
Nancy A Tanchel, MD · Liberty Laser Eye Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2016-05-31
Countries
- United States
Study Locations
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