Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000341820
Ethics application status
Approved
Date submitted
15/03/2012
Date registered
26/03/2012
Date last updated
1/09/2024
Date data sharing statement initially provided
1/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Surgical and Medical Therapy on the Natural History of Moderate to Severe Thyroid Eye Disease
Scientific title
Observational study of the effects of total thyroidectomy versus medical therapy with anti-thyroid drugs or radioactive iodine on thyroid eye disease activity
Secondary ID [1] 280153 0
nil
Universal Trial Number (UTN)
U1111-1129-1599
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
thyroid eye disease 286074 0
Graves' disease 286075 0
Condition category
Condition code
Eye 286270 286270 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 286271 286271 0 0
Thyroid disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study assessing the natural history of thyroid eye disease over a 12 month period in response to total thyroidectomy.
Intervention code [1] 284480 0
Not applicable
Comparator / control treatment
medical therapy with anti-thyroid drugs - carbimazole or propylthiouracil or radioactive iodine. Antithyroid drug dose varies according to thyroid function tests. Radioactive iodine is given as a fixed dose of 555MBq but repeat dose may be required. Duration of anti-thyroid drug treatment is a minimum of 12 months.
Control group
Active

Outcomes
Primary outcome [1] 286736 0
Change in clinical activity score >3 points
Timepoint [1] 286736 0
Baseline, 6 weeks, 3 monthly for a total of 12 months
Secondary outcome [1] 296558 0
>10 point change in score in Graves' ophthalmopathy quality of life questionnaire
Timepoint [1] 296558 0
Baseline, 6 weeks, 3 monthly for a total of 12 months
Secondary outcome [2] 296559 0
>50% reduction in TSH receptor antibody levels from baseline measured by blood analysis
Timepoint [2] 296559 0
Baseline, 6 weeks, 3 monthly for a total of 12 months
Secondary outcome [3] 296560 0
Need for systemic or intraocular steroid based on clinical assessments
Timepoint [3] 296560 0
Baseline, 6 weeks, 3 monthly for a total of 12 months
Secondary outcome [4] 296561 0
Reduction in Stir ratio on MRI imaging
Timepoint [4] 296561 0
Baseline and 4-6 weeks post-thyroidectomy

Eligibility
Key inclusion criteria
Patients with thyroid eye disease
Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/03/2012
Actual
8/08/2012
Date of last participant enrolment
Anticipated
Actual
13/10/2017
Date of last data collection
Anticipated
12/10/2018
Actual
Sample size
Target
60
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 4205 0
New Zealand
State/province [1] 4205 0
Waikato

Funding & Sponsors
Funding source category [1] 284902 0
Self funded/Unfunded
Name [1] 284902 0
Country [1] 284902 0
New Zealand
Primary sponsor type
Individual
Name
Dr Stephen Ng
Address
Department of Ophthalmology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 283778 0
Individual
Name [1] 283778 0
Associate Professor John V Conaglen
Address [1] 283778 0
Department of Endocrinology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country [1] 283778 0
New Zealand
Other collaborator category [1] 260624 0
Individual
Name [1] 260624 0
Dr Marianne Elston
Address [1] 260624 0
Department of Endocrinology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country [1] 260624 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286899 0
Northern Y Regional Ethics committee
Ethics committee address [1] 286899 0
c/- Ministry of Health
Level 3, Bridgewater Building
130 Grantham St
Hamilton 3204
Ethics committee country [1] 286899 0
New Zealand
Date submitted for ethics approval [1] 286899 0
Approval date [1] 286899 0
09/03/2012
Ethics approval number [1] 286899 0
NTY/11/08/091

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33931 0
Dr Stephen Ng
Address 33931 0
Department of ophthalmology
Waikato Hospital
Private Bag 3200
Hamilton 3240
New Zealand
Country 33931 0
New Zealand
Phone 33931 0
+64 7 8398899
Fax 33931 0
Email 33931 0
[email protected]
Contact person for public queries
Name 17178 0
Dr Stephen Ng
Address 17178 0
Department of Ophthalmology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 17178 0
New Zealand
Phone 17178 0
+647898899
Fax 17178 0
Email 17178 0
[email protected]
Contact person for scientific queries
Name 8106 0
Dr Stephen Ng
Address 8106 0
Department of Ophthalmology
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 8106 0
New Zealand
Phone 8106 0
+647898899
Fax 8106 0
Email 8106 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.