Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

NCT ID: NCT04927468

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-07-01

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

Conditions

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Strabismus, Mechanical Graves Ophthalmopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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supramaximal rectus recession

supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy

Group Type EXPERIMENTAL

supramaximal rectus recession

Intervention Type PROCEDURE

inferior rectus recession is 10mm,medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus

normal rectus recession

normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy

Group Type ACTIVE_COMPARATOR

normal rectus recession

Intervention Type PROCEDURE

inferior rectus recession is 7mm,medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus

Interventions

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supramaximal rectus recession

inferior rectus recession is 10mm,medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus

Intervention Type PROCEDURE

normal rectus recession

inferior rectus recession is 7mm,medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Huasheng Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yang Huasheng

Role: CONTACT

+00862087331539

Other Identifiers

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yanghs20210607

Identifier Type: -

Identifier Source: org_study_id

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