Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

Not Applicable

• Conditions: Strabismus, Mechanical; Graves Ophthalmopathy
• Interventions: Procedure: supramaximal rectus recession; Procedure: normal rectus recession

• Registration Number: NCT04927468
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Study First Posted: 2021-06-16
• Last Update Posted: 2021-06-16
• Study Start: 2021-07-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supramaximal rectus recession	supramaximal rectus recession	supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy
normal rectus recession	normal rectus recession	normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy

Primary Outcome Measures

Name	Time	Method
Postoperative deviations	6 months	Postoperative deviations in the primary position were measured in prism diopters

Secondary Outcome Measures

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