Keratoconus Clinical Trial
Official title:
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Verified date | September 2018 |
Source | Cxlusa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.
Status | Terminated |
Enrollment | 3493 |
Est. completion date | February 3, 2017 |
Est. primary completion date | February 3, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - 12 years of age or older - Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD). - Diagnosis of FFKC - History of Radial Keratotomy with fluctuating vision - Ability to provide written informed consent - Likely to complete all study visits - Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam - At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK) Exclusion Criteria: - Severe corneal scarring that markedly affects vision - Contraindications to any study medications or their components - Pregnancy or breast feeding - Active Herpes Corneal Disease |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Eye Clinic | Brecksville | Ohio |
United States | TLC Laser Eye Center | Fairfax | Virginia |
United States | Chicago Cornea Consultants, LTD | Hoffman Estates | Illinois |
United States | Harvard Eye Associates | Laguna Hills | California |
United States | Corneal Consultants of Colorado, P.C | Littleton | Colorado |
United States | The Center for Excellence in Eye Care | Miami | Florida |
United States | TLC Laser Eye Center | Rockville | Maryland |
United States | Ophthalomology Associates | Saint Louis | Missouri |
United States | Clear View Eye & Laser Medical Center | San Diego | California |
United States | Schwartz Laser Eye Center | Scottsdale | Arizona |
United States | Northwest Eye Surgeons | Seattle | Washington |
United States | Empire Eye Physicians | Spokane Valley | Washington |
United States | Talamo Laser Eye Center | Waltham | Massachusetts |
United States | South Shore Eye Care LLP | Wantagh | New York |
United States | Davidorf Eye Group | West Hills | California |
Lead Sponsor | Collaborator |
---|---|
Cxlusa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within | 1 year | ||
Secondary | increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin | 1 year |
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