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The purpose of this study is to determine whether combination of orbital compression surgery with strabismus surgery is better than strabismus surgery after orbital compression surgery in the treatment of moderate-to-severe thyroid associated ophthalmopathy
This study will be a interventional case series. Patients with moderate-to-severe thyroid associated ophthalmopathy will be randomized to receive combination of orbital compression surgery with strabismus surgery or strabismus surgery after orbial compression surgery.Patients will be followed for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination of orbital compression and strabismus surgery | Experimental | orbital compression and strabismus surgery are performed at the same time |
|
| perform strabismus surgery after orbital compression | Active Comparator | Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination of orbital compression surgery and strabismus surgery | Procedure | combination of orbital compression surgery and strabismus surgery at the same time |
|
| Measure | Description | Time Frame |
|---|---|---|
| quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) . | All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = [(raw score - 8)/16 9 100]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = [(raw score - *)/(2x*) x100] where * is the number of completed items. | 6 weeks after surgery |
| quality of life, measured by GO-QoL(quality of life with Grave's Orbitopathy) . | All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = [(raw score - 8)/16 9 100]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = [(raw score - *)/(2x*) x100] where * is the number of completed items. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| strabismus status | angle of deviation including up-gaze, down-gaze ,left and right-gaze | 6 weeks after surgery |
| strabismus status | angle of deviation including up-gaze, down-gaze ,left and right-gaze |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua sheng Yang, M.D,PHD | Contact | +8620-87331539 | yanghs64@162.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | 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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| orbital compression | Procedure | orbital compression |
|
| 6 months after surgery |
| 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 |