Keratoconus Clinical Trial
Official title:
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Verified date | December 2021 |
Source | Cxlusa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.
Status | Terminated |
Enrollment | 2228 |
Est. completion date | December 27, 2020 |
Est. primary completion date | December 27, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years and older |
Eligibility | Inclusion Criteria: - A diagnosis of at least one of the following conditions: 1. Keratoconus 2. Forme fruste keratoconus 3. Post-LASIK ectasia 4. Pellucid marginal degeneration 5. Forme fruste pellucid marginal degeneration 6. Diurnal fluctuation post-radial keratotomy 7. Terrien's marginal degeneration Exclusion Criteria: 1. Corneal thickness < 375 microns measured by ultrasound or Pentacam. 2. Contraindications or hypersensitivities to any study medications or their components. 3. Pregnancy or breastfeeding. 4. Any history of herpes simplex corneal disease in an eye to be treated. 5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. 6. Inability to cooperate with diagnostic tests. 7. Enrollment in another ophthalmic clinical trial. |
Country | Name | City | State |
---|---|---|---|
United States | Woolfson Eye Institute | Atlanta | Georgia |
United States | Cleveland Eye Clinic | Brecksville | Ohio |
United States | Chicago Cornea Consultants | Chicago | Illinois |
United States | Cornea Associates of Texas | Dallas | Texas |
United States | Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois |
United States | Cornea Consultants of Colorado | Littleton | Colorado |
United States | Ophthalmology Associates | Saint Louis | Missouri |
United States | Goodman Eye Center | San Francisco | California |
United States | Schwartz Laser Eye Center | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Cxlusa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Corrected Distance Visual Acuity (CDVA) | Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline | Baseline and 6 and 12 months | |
Secondary | Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline | Baseline and 6 and 12 months | |
Secondary | Change From Baseline in Maximum Keratometry (KMax) | Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline. | Baseline and 6 and 12 months |
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