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

Not Applicable

• Conditions: Thyroid Associated Ophthalmopathy
• Interventions: Procedure: combination of orbital compression surgery and strabismus surgery; Procedure: orbital compression

• Registration Number: NCT04919694
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-01-19
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-06
• Last Update Submitted: 2021-06-06
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09
• Study Start: 2021-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combination of orbital compression and strabismus surgery	combination of orbital compression surgery and strabismus surgery	orbital compression and strabismus surgery are performed at the same time
perform strabismus surgery after orbital compression	orbital compression	Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done.

Primary Outcome Measures

Name	Time	Method
quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .	6 weeks after surgery	All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = \[(raw score - 8)/16 9 100\]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = \[(raw score - \*)/(2x\*) x100\] where \* is the number of completed items.
quality of life, measured by GO-QoL(quality of life with Grave's Orbitopathy) .	6 months	All GO-QoL questions were scored as 'severely limited' (one point), 'a little limited' (two points) or 'not limited at all' (three points). The questions 1-8 for visual functioning (VF) and questions 9-16 for appearance (AP)were summed to produce two raw scores from 8 to 24 points and then transformed to two total scores from 0 to 100 by the following formula: total score = \[(raw score - 8)/16 9 100\]. In both cases, higher total scores indicate better QoL. When there were missing values, total scores were calculated for the remaining completed items. The transformation was then adjusted to total score = \[(raw score - \*)/(2x\*) x100\] where \* is the number of completed items.

Secondary Outcome Measures

Name	Time	Method
strabismus status	6 months after surgery	angle of deviation including up-gaze, down-gaze ,left and right-gaze

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China