The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy (C3R)
Primary Purpose
Bullous Keratopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultraviolet-A
Sponsored by
About this trial
This is an interventional treatment trial for Bullous Keratopathy
Eligibility Criteria
Inclusion Criteria:
- patients with bollous keratopathy
Exclusion Criteria:
- corneal scarring or contemporary eye disease affecting VA were excluded.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01106274
First Posted
April 16, 2010
Last Updated
April 16, 2010
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01106274
Brief Title
The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy
Acronym
C3R
Official Title
Study of the Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown potential to improve the signs and symptoms of bullous keratopathy .The objective of this study is to demonstrate the effects of C3R to treat bullous keratopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Keratopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
ultraviolet-A
Intervention Description
Corneal cross linking (C3R) with riboflavin and ultraviolet-A (UVA, 370 nm, 3mW/cm2) for 30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with bollous keratopathy
Exclusion Criteria:
corneal scarring or contemporary eye disease affecting VA were excluded.
12. IPD Sharing Statement
Learn more about this trial
The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy
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