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
About this trial
This is an interventional treatment trial for Thyroid Associated Ophthalmopathy
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
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
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
Learn more about this trial
Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy
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