We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430547
First Posted: February 2, 2007
Last Update Posted: February 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Melbourne
National Health and Medical Research Council, Australia
Information provided by:
Barwon Health
  Purpose
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.

Condition Intervention
Graves' Ophthalmopathy Drug: Carbimazole, radio-active iodine (I131)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

Resource links provided by NLM:


Further study details as provided by Barwon Health:

Primary Outcome Measures:
  • Onset or progression of ophthalmopathy following radio-active iodine therapy

Estimated Enrollment: 60
Study Start Date: August 2003
Estimated Study Completion Date: January 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430547


Locations
Australia, Victoria
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia, 3220
Sponsors and Collaborators
Barwon Health
University of Melbourne
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Jack R Wall, BMBS, FRACP, PhD University of Sydney
  More Information

ClinicalTrials.gov Identifier: NCT00430547     History of Changes
Other Study ID Numbers: 03/53
First Submitted: February 1, 2007
First Posted: February 2, 2007
Last Update Posted: February 2, 2007
Last Verified: August 2003

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Antibodies
Carbimazole
Immunologic Factors
Physiological Effects of Drugs
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists