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

Progressive Keratoconus Clinical Trial

— CXL  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00925327
• Other study ID #: UVX-004
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 19, 2009
• Last updated: June 19, 2009

Study information

• Verified date: June 2009
• Source: Peschke Meditrade, GmbH
• Contact: Erin D. Stahl, MD
• Phone: 816-234-3046
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus
• Progressive Keratoconus

Intervention

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

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Peschke Meditrade, GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in keratometry		3 Months	Yes
Secondary	Change in manifest refraction spherical equivalent		3 Month	Yes