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

Peschke GmbH

Status and phase: Unknown; Phase 2

Conditions: Progressive Keratoconus

Treatments: Other: Corneal collagen cross-linking with riboflavin/UVA light

Study type: Interventional

Funder types: Industry

Identifiers

NCT00925327

UVX-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Corneal collagen cross-linking with riboflavin and UVA light

Experimental group

Treatment:

Other: Corneal collagen cross-linking with riboflavin/UVA light