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

NCT ID: NCT04919694

Last Updated: 2021-06-09

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

2023-12-31

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.

Conditions

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Thyroid Associated Ophthalmopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combination of orbital compression and strabismus surgery

orbital compression and strabismus surgery are performed at the same time

Group Type EXPERIMENTAL

combination of orbital compression surgery and strabismus surgery

Intervention Type PROCEDURE

combination of orbital compression surgery and strabismus surgery at the same time

perform strabismus surgery after orbital compression

Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done.

Group Type ACTIVE_COMPARATOR

orbital compression

Intervention Type PROCEDURE

orbital compression

Interventions

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combination of orbital compression surgery and strabismus surgery

combination of orbital compression surgery and strabismus surgery at the same time

Intervention Type PROCEDURE

orbital compression

orbital compression

Intervention Type PROCEDURE

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
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

Sun Yat-sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Hua sheng Yang, M.D,PHD

Role: CONTACT

+8620-87331539

Other Identifiers

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yanghs20210106

Identifier Type: -

Identifier Source: org_study_id

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