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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periorbitally Injected Glucocorticoids | Experimental | Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up. |
|
| Observe | No Intervention | Observe and wait. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoids | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
General conditions:
Eye condition:
Exclusion Criteria:
General situation:
Eye conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huasheng Yang, M.D, PHD | Contact | +8620-87331539 | yanghs64@126.com | |
| Huasheng Yang, Doctor | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Huasheng Yang, Doctor | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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| baseline、3months、6months、9months、12months |
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |