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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Peschke Meditrade, GmbH.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Peschke Meditrade, GmbH
ClinicalTrials.gov Identifier:
NCT00925327
First received: June 19, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Peschke Meditrade, GmbH:

Primary Outcome Measures:
  • Change in keratometry [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in manifest refraction spherical equivalent [ Time Frame: 3 Month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 7
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925327

Contacts
Contact: Erin D. Stahl, MD 816-234-3046

Locations
United States, Missouri
Children's Mercy Hospitals and Clinics Not yet recruiting
Kansas City, Missouri, United States, 65108
Contact: Erin D. Stahl, MD    816-234-3046      
Principal Investigator: Scott E. Olitsky, MD         
Sub-Investigator: Erin D. Stahl, MD         
Sponsors and Collaborators
Peschke Meditrade, GmbH
  More Information

No publications provided

Responsible Party: Rudi Peschke, Peschke Meditrade GmbH
ClinicalTrials.gov Identifier: NCT00925327     History of Changes
Other Study ID Numbers: UVX-004
Study First Received: June 19, 2009
Last Updated: June 19, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014