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
Recruitment status was Not yet recruiting
Sponsor:
Peschke Meditrade, GmbH
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
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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 May 19, 2013