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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
Mashhad University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bullous Keratopathy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 16, 2010
    Last Updated
    April 16, 2010
    Sponsor
    Mashhad University of Medical Sciences
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    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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