Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Graves Ophthalmopathy; Strabismus, Mechanical
• Intervention / Treatment: Procedure: supramaximal rectus recession; Procedure: normal rectus recession

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Huasheng; Phone Number: +00862087331539; Email: yanghs64@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: supramaximal rectus recession; supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy	Procedure: supramaximal rectus recession; inferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus
ACTIVE_COMPARATOR: normal rectus recession; normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy	Procedure: normal rectus recession; inferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (ACTUAL): June 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Cranial Nerve Diseases; Ocular Motility Disorders; Eye Diseases; Graves Ophthalmopathy; Strabismus
• Other Study ID Numbers: yanghs20210607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No