Graves Disease, Graves Ophthalmopathy, Graves' Ophthalmopathy Worsened
Conditions
Brief summary
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO. Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months. Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
Detailed description
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO. Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months. Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.
Interventions
DRUGAntithyroid Drug
Antithyroid drug
PROCEDURETotal thyroidectomy
Operation
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Observer blinded analysis
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. GD and GO onset \< 12 months 2. no previous GD treatment other than antithyroid drugs (ATD) 3. first relapse after decrease of antithyroid medication within 4-6 months 4. GO treatment with glucocorticoids based on the Kahaly scheme 5. patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO 6. clinically active inflammation according to CAScore (\>3/7) 7. informed consent
Exclusion criteria
1. GD and GO onset \> 12 months 2. more than one relapse of GO longer than 6 months from diagnosis 3. previous GD treatment by RAI or surgery 4. SNI greater than 7.0 5. urgent orbital decompression surgery 6. loss of vision 7. loss of visual field 8. loss of color vision 9. patients not receiving glucocorticoids for GO 10. cytological findings of postsurgical histopathological results suspicious for malignancy 11. pregnancy or breast-feeding 12. contraindication to GC 13. halt of GC therapy 14. Patients with diabetes mellitus 15. age below 18 years 16. no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle index (MI) from ultrasound measurements | 12 months | Muscle index (MI) from ultrasound measurements |
| Thyroid antibodies | 12 months | Thyroid antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAScore/NOSPECS score | 12 months | CAScore/NOSPECS score |
| Superonasal index measurements via ultrasound | 12 months | Superonasal index measurements via ultrasound |
| Quality of life score | 12 months | Quality of life score |
Countries
Austria
Contacts
Primary ContactLindsay Brammen, MD
Backup ContactPhilipp Riss, MD
Outcome results
None listed