Status:
UNKNOWN
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
Lead Sponsor:
Peschke Meditrade, GmbH
Conditions:
Progressive Keratoconus
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their...
Detailed Description
This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the ...
Eligibility Criteria
Inclusion
- Age 6 to 18 years
- Having a diagnosis of progressive keratoconus
- Signed written informed consent
- Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
- Willingness and ability to comply with schedule for follow-up visits
Exclusion
- Corneal pachymetry at the screening exam that is \<400 microns at the thinnest point
- Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- A history of delayed epithelial healing in the eye(s) to be treated
- Pregnancy or lactation during the course of the study
- A known sensitivity to study medications
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00925327
Last Update
June 22 2009
Active Locations (1)
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1
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 65108