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

• Sponsor: Peschke Meditrade, GmbH (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00925327
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Progressive Keratoconus	Other: Corneal collagen cross-linking with riboflavin/UVA light	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Corneal collagen cross-linking with riboflavin and UVA light	Other: Corneal collagen cross-linking with riboflavin/UVA light; Corneal collagen cross-linking with riboflavin/UVA light

Outcome Measures

Primary Outcome Measures

1. Change in keratometry [3 Months]

Secondary Outcome Measures

1. Change in manifest refraction spherical equivalent [3 Month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	65108

Sponsors and Collaborators

• Peschke Meditrade, GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00925327
• Other Study ID Numbers: UVX-004
• First Posted: Jun 22, 2009
• Last Update Posted: Jun 22, 2009
• Last Verified: Jun 1, 2009

• Additional relevant MeSH terms: Keratoconus; Riboflavin

Study Results

No Results Posted as of Jun 22, 2009