Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

Graves' Ophthalmopathy Clinical Trial

Official title:

Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430547
• Other study ID #: 03/53
• Status: Completed
• Phase: N/A
• First received: February 1, 2007
• Last updated: February 1, 2007
• Start date: August 2003
• Est. completion date: January 2006

Study information

• Verified date: August 2003
• Source: Barwon Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Graves' Ophthalmopathy

Intervention

Drug:
• Carbimazole, radio-active iodine (I131)

Locations

Country	Name	City	State
Australia	Barwon Health - The Geelong Hospital	Geelong	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Barwon Health	National Health and Medical Research Council, Australia, University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset or progression of ophthalmopathy following radio-active iodine therapy