Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

This study has been completed.
Sponsor:
Collaborators:
University of Melbourne
National Health and Medical Research Council, Australia
Information provided by:
Barwon Health
ClinicalTrials.gov Identifier:
NCT00430547
First received: February 1, 2007
Last updated: NA
Last verified: August 2003
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 The University of Sydney
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00430547     History of Changes
Other Study ID Numbers: 03/53
Study First Received: February 1, 2007
Last Updated: February 1, 2007
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases, Hereditary
Goiter
Graves Disease
Hyperthyroidism
Immune System Diseases
Orbital Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on October 23, 2014