Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy

Detailed Description
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To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy

Official Title
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The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession

Conditions
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Strabismus, Mechanical, Graves Ophthalmopathy

Intervention / Treatment
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* Procedure: supramaximal rectus recession
* Procedure: normal rectus recession


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Grave's ophthalmopathy angle of deviation more than 20° clinically and biochemically euthyroid for at least 3 months; a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction monocular and mainly single extraocular muscle restricted motility Exclusion Criteria: Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supramaximal rectus recession<br>supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy | Procedure: supramaximal rectus recession<br>* inferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus<br>|
| Active Comparator: normal rectus recession<br>normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy | Procedure: normal rectus recession<br>* inferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative deviations | Postoperative deviations in the primary position were measured in prism diopters | 6 weeks | 
| Postoperative deviations | Postoperative deviations in the primary position were measured in prism diopters | 3 months | 
| Postoperative deviations | Postoperative deviations in the primary position were measured in prism diopters | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| binocular single vision | measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore. | 6 weeks | 
| binocular single vision | measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore. | 3 months | 
| binocular single vision | measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore. | 6 months | 
| stereoacuity | measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis. | 6 weeks | 
| stereoacuity | measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis. | 3 months | 
| stereoacuity | measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis. | 6 months | 
| ocular motility | evaluate the ocular motility with fixed visual field examination ,scaled from -4 to +4 | 6 weeks | 
| ocular motility | evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4 | 3 months | 
| ocular motility | evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4 | 6 months |