Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO

Study Overview
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Brief Summary
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The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.

Official Title
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Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study

Conditions
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Thyroid Associated Ophthalmopathy

Intervention / Treatment
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* Drug: Glucocorticoids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General conditions: clinically diagnosed as thyroid disease; able and willing to participate in clinical trials and ensure regular follow-up. Eye condition: patients with monocular disease diagnosed by TAO; EUGOGO/NOSPECS grade was mild and CAS score was less than 3; the course of eye disease was less than 12mo and had not been treated in the past. Exclusion Criteria: General situation: patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ; blood pressure still fluctuated > 180/110mmHg after medication; obvious liver and kidney insufficiency; contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.); patients with severe abnormal blood coagulation; patients with other systemic immune diseases; any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors); history of chronic infection; pregnant and lactating women. Eye conditions: B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.); moderate to severe TAO, in either eye requiring local or systemic treatment; periorbital infectious diseases, hemorrhagic diseases; uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases. those who studied the eyes who had a history of arbitrary surgery; those who were considered by the researchers to be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periorbitally Injected Glucocorticoids<br>Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up. | Drug: Glucocorticoids<br>* 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.<br>|
| No Intervention: Observe<br>Observe and wait. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Clinical Activity Score (CAS) score | 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. | baseline、3months、6months、9months、12months | 
| Change of NOSPECS score | 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. | baseline、3months、6months、9months、12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Comparison of adverse events rate in each arm and an inter-arm. | baseline、3months、6months、9months、12months | 
| Quality of life questionnaires (GO-QoL) | 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. | baseline、3months、6months、9months、12months |