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Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

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ClinicalTrials.gov Identifier: NCT00430547
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : February 2, 2007
Sponsor:
Collaborators:
University of Melbourne
National Health and Medical Research Council, Australia
Information provided by:
Barwon Health

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
Study Start Date : August 2003
Estimated Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


Information from the National Library of Medicine

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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

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

ClinicalTrials.gov Identifier: NCT00430547     History of Changes
Other Study ID Numbers: 03/53
First Posted: February 2, 2007    Key Record Dates
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