NCT00925327

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Peschke Meditrade, GmbH · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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

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 patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Conditions

• Progressive Keratoconus

Interventions

Type	Name	Description
OTHER	Corneal collagen cross-linking with riboflavin/UVA light	Corneal collagen cross-linking with riboflavin/UVA light

Timeline

• First posted: 2009-06-22
• Last updated: 2009-06-22

Locations

1 site across 1 country: United States