Thyroid Associated Ophthalmopathy
Conditions
Brief summary
The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.
Interventions
DRUGGlucocorticoids
Periorbital injection of glucocorticoid. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
General conditions: 1. clinically diagnosed as thyroid disease; 2. able and willing to participate in clinical trials and ensure regular follow-up. Eye condition: 1. patients with monocular disease diagnosed by TAO; 2. EUGOGO/NOSPECS grade was mild and CAS score was less than 3; 3. the course of eye disease was less than 12mo and had not been treated in the past.
Exclusion criteria
General situation: 1. patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ; 2. blood pressure still fluctuated \> 180/110mmHg after medication; 3. obvious liver and kidney insufficiency; 4. contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.); 5. patients with severe abnormal blood coagulation; 6. patients with other systemic immune diseases; 7. any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors); 8. history of chronic infection; 9. pregnant and lactating women. Eye conditions: 1. B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.); 2. moderate to severe TAO, in either eye requiring local or systemic treatment; 3. periorbital infectious diseases, hemorrhagic diseases; 4. uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases. 5. those who studied the eyes who had a history of arbitrary surgery; 6. those who were considered by the researchers to be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Clinical Activity Score (CAS) score | baseline、3months、6months、9months、12months | Comparison of CAS scores before and after treatment in each arm and an inter-arm. The range of CAS scores is 0-7, with 3 as the boundary. The higher the score, the higher the activity. |
| Change of NOSPECS score | baseline、3months、6months、9months、12months | Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm. The NOSPECS score was 0-6. The higher the score, the higher the severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | baseline、3months、6months、9months、12months | Comparison of adverse events rate in each arm and an inter-arm. |
| Quality of life questionnaires (GO-QoL) | baseline、3months、6months、9months、12months | Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm. The GO-QOL score is between 0 and 100. The higher the score, the better the quality of life. |
Countries
China
Contacts
Primary ContactHuasheng Yang, M.D, PHD
Backup ContactHuasheng Yang, Doctor
Outcome results
None listed