Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy

Conditions
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Thyroid Associated Ophthalmopathy

Intervention / Treatment
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* Procedure: combination of orbital compression surgery and strabismus surgery
* Procedure: orbital compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate-to-severe thyroid associate ophthalmopathy CAS≤3 score monocular strabismus,deviation≥20° or 35▲ stable thyroid function for at least 6 months, confirmed by an endocrinologist Exclusion Criteria: any previous disease in the study eye. any previous systematic disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination of orbital compression and strabismus surgery<br>orbital compression and strabismus surgery are performed at the same time | Procedure: combination of orbital compression surgery and strabismus surgery<br>* combination of orbital compression surgery and strabismus surgery at the same time<br>|
| Active Comparator: perform strabismus surgery after orbital compression<br>Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done. | Procedure: orbital compression<br>* orbital compression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 6 months after surgery |