Back to resultsSafety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus (CXL)
Primary Purpose
Progressive Keratoconus
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Corneal collagen cross-linking with riboflavin/UVA light
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Keratoconus
Eligibility 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
Sites / Locations
- Children's Mercy Hospitals and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Corneal collagen cross-linking with riboflavin and UVA light
Arm Description
Outcomes
Primary Outcome Measures
Change in keratometry
Secondary Outcome Measures
Change in manifest refraction spherical equivalent
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00925327
Brief Title
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
Acronym
CXL
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Peschke Meditrade, GmbH
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corneal collagen cross-linking with riboflavin and UVA light
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Corneal collagen cross-linking with riboflavin/UVA light
Intervention Description
Corneal collagen cross-linking with riboflavin/UVA light
Primary Outcome Measure Information:
Title
Change in keratometry
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Change in manifest refraction spherical equivalent
Time Frame
3 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin D. Stahl, MD
Phone
816-234-3046
Facility Information:
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
65108
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin D. Stahl, MD
Phone
816-234-3046
First Name & Middle Initial & Last Name & Degree
Scott E. Olitsky, MD
First Name & Middle Initial & Last Name & Degree
Erin D. Stahl, MD
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
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