Comparison of Surgical and Medical Therapy on the Natural History of Moderate to Severe Thyroid Eye Disease

Not Applicable

• Conditions: thyroid eye disease; Graves' disease; Metabolic and Endocrine - Thyroid disease; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12612000341820
• Lead Sponsor: Dr Stephen Ng

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-26
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Patients with thyroid eye disease
Able to give informed consent

Exclusion Criteria

Patients receiving oral or intravenous steroid medication not for thyroid eye disease
<18 years
Unable to consent
Pregnant patients
Significant pre-existing (non-thyroid) eye disease making interpretation of results difficult

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in clinical activity score >3 points[ Baseline, 6 weeks, 3 monthly for a total of 12 months]

Secondary Outcome Measures

Name	Time	Method
>10 point change in score in Graves' ophthalmopathy quality of life questionnaire[ Baseline, 6 weeks, 3 monthly for a total of 12 months];>50% reduction in TSH receptor antibody levels from baseline measured by blood analysis[ Baseline, 6 weeks, 3 monthly for a total of 12 months];Need for systemic or intraocular steroid based on clinical assessments[ Baseline, 6 weeks, 3 monthly for a total of 12 months];Reduction in Stir ratio on MRI imaging[ Baseline and 4-6 weeks post-thyroidectomy]