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

Observational study of the effects of total thyroidectomy versus medical therapy with anti-thyroid drugs or radioactive iodine on thyroid eye disease activity

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612000341820
Enrollment
21
Registered
2012-03-26
Start date
2012-08-08
Completion date
2017-10-13
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Some patients with Graves’ disease (a form of overactive thyroid) develop thyroid eye disease (TED) that may range from mild to severe. In many cases, patients can suffer disabling eye problems including double vision, eye pain, chronic pain and permanent disfigurement. In severe cases patients may need steroid therapy and occasionally surgery to preserve their eyesight. “Definitive” treatment of Graves’ disease is either by surgical removal of the thyroid gland (thyroidectomy) or medical treatment with radioactive iodine to destroy the thyroid gland. Previous studies have described a rapid improvement in TED after surgery to remove the thyroid gland. To date, this has not been rigorously assessed by well-designed studies. We wish to objectively assess the response of the eye disease to surgical removal of the thyroid using regular clinical assessments by an experienced ophthalmologist, radiological assessment using MRI scans and subjectively by a patient questionnaire in addition to blood tests in a group of patients with active thyroid eye disease. The eye disease in these patients would then be compared to patients who have one of the other two usual treatments for thyrotoxicosis (anti-thyroid tablets or radioactive iodine). Hypothesis: Patients undergoing a total thyroidectomy for Graves’ disease experience a more rapid improvement in thyroid eye disease (TED) than patients having medical therapy with anti-thyroid drugs or radioactive iodine and this improvement is sustained over a twelve month period of follow up. Aims: 1. To perform objective and subjective assessments of the severity of thyroid eye disease in patients who have pre-existing thyroid eye disease, who undergo definitive therapy with total thyroidectomy or have medical therapy with anti-thyroid drugs or radioactive iodine. 2. To determine the optimal systemic treatment for a patient who has pre-existing moderate to severe TED 3. To assess the response of thyroid receptor antibodies in response to a total thyroidectomy versus medical therapy 4. To assess short T1 inversion recovery (STIR) sequence MRI imaging as a modality for monitoring thyroid eye disease.

Interventions

Observational study assessing the natural history of thyroid eye disease over a 12 month period in response to total thyroidectomy.

Sponsors

Dr Stephen Ng
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026