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

Tracking Information

First Received Date ^ICMJE

February 1, 2007

Last Updated Date

February 1, 2007

Start Date ^ICMJE

August 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Onset or progression of ophthalmopathy following radio-active iodine therapy

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

Official Title ^ICMJE

Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Graves' Ophthalmopathy

Intervention ^ICMJE

Drug: Carbimazole, radio-active iodine (I131)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00430547

Other Study ID Numbers ^ICMJE

03/53

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Barwon Health

Collaborators ^ICMJE

University of Melbourne
National Health and Medical Research Council, Australia

Investigators ^ICMJE

Principal Investigator:

Jack R Wall, BMBS, FRACP, PhD

The University of Sydney

Information Provided By

Barwon Health

Verification Date

August 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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