Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus

Status unconfirmed · Phase 2

Conditions studied: Progressive Keratoconus

In brief

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 capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.

Key facts

Study ID

NCT00925327

Run by

Peschke Meditrade, GmbH

People needed

7

Last updated by the study team

2009-06-22

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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