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

June 19, 2009 updated by: Peschke Meditrade, GmbH
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Erin D. Stahl, MD
  • Phone Number: 816-234-3046

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 65108
        • Children's Mercy Hospitals and Clinics
        • Contact:
          • Erin D. Stahl, MD
          • Phone Number: 816-234-3046
        • Principal Investigator:
          • Scott E. Olitsky, MD
        • Sub-Investigator:
          • Erin D. Stahl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in keratometry
Time Frame: 3 Months
3 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in manifest refraction spherical equivalent
Time Frame: 3 Month
3 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peschke Meditrade, GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2009

Last Update Submitted That Met QC Criteria

June 19, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVX-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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