Back to resultsThyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
Primary Purpose
Graves' Ophthalmopathy
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Carbimazole, radio-active iodine (I131)
Sponsored by
About this trial
This is an interventional treatment trial for Graves' Ophthalmopathy
Eligibility Criteria
Inclusion Criteria:
- Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy
Exclusion Criteria:
- Pre-existing eye disease: e.g. orbital surgery, orbital irradiation or significant loss of vision
- Age < 18 years
- Inability to consent to participation in the study
- Pregnancy
- History of radio-active iodine therapy
Sites / Locations
- Barwon Health - The Geelong Hospital
Outcomes
Primary Outcome Measures
Onset or progression of ophthalmopathy following radio-active iodine therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT00430547
First Posted
February 1, 2007
Last Updated
February 1, 2007
Sponsor
Barwon Health
Collaborators
University of Melbourne, National Health and Medical Research Council, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00430547
Brief Title
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
Official Title
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2003
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Barwon Health
Collaborators
University of Melbourne, National Health and Medical Research Council, Australia
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether radioactive iodine, as compared to anti-thyroid medications, is a risk factor for the development or progression of thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease. The other aim of this study is to determine the incidence of the various ophthalmopathy subtypes and the utility of orbital antibodies in the diagnosis, classification and monitoring of patients with thyroid-associated ophthalmopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves' Ophthalmopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Carbimazole, radio-active iodine (I131)
Primary Outcome Measure Information:
Title
Onset or progression of ophthalmopathy following radio-active iodine therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy
Exclusion Criteria:
Pre-existing eye disease: e.g. orbital surgery, orbital irradiation or significant loss of vision
Age < 18 years
Inability to consent to participation in the study
Pregnancy
History of radio-active iodine therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack R Wall, BMBS, FRACP, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barwon Health - The Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
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