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

Primary Purpose

Thyroid Associated Ophthalmopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
combination of orbital compression surgery and strabismus surgery
orbital compression
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Associated Ophthalmopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combination of orbital compression and strabismus surgery

perform strabismus surgery after orbital compression

Arm Description

orbital compression and strabismus surgery are performed at the same time

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

Outcomes

Primary Outcome Measures

quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .
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) .
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

strabismus status
angle of deviation including up-gaze, down-gaze ,left and right-gaze
strabismus status
angle of deviation including up-gaze, down-gaze ,left and right-gaze

Full Information

First Posted
January 19, 2021
Last Updated
June 6, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04919694
Brief Title
Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy
Official Title
The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Associated Ophthalmopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination of orbital compression and strabismus surgery
Arm Type
Experimental
Arm Description
orbital compression and strabismus surgery are performed at the same time
Arm Title
perform strabismus surgery after orbital compression
Arm Type
Active Comparator
Arm Description
Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done.
Intervention Type
Procedure
Intervention Name(s)
combination of orbital compression surgery and strabismus surgery
Intervention Description
combination of orbital compression surgery and strabismus surgery at the same time
Intervention Type
Procedure
Intervention Name(s)
orbital compression
Intervention Description
orbital compression
Primary Outcome Measure Information:
Title
quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .
Description
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.
Time Frame
6 weeks after surgery
Title
quality of life, measured by GO-QoL(quality of life with Grave's Orbitopathy) .
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
strabismus status
Description
angle of deviation including up-gaze, down-gaze ,left and right-gaze
Time Frame
6 weeks after surgery
Title
strabismus status
Description
angle of deviation including up-gaze, down-gaze ,left and right-gaze
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua sheng Yang, M.D,PHD
Phone
+8620-87331539
Email
yanghs64@162.com
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

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

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