Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy
The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 9, 2021
June 1, 2021
2.5 years
January 19, 2021
June 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
6 weeks after surgery
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.
6 months
Secondary Outcomes (2)
strabismus status
6 weeks after surgery
strabismus status
6 months after surgery
Study Arms (2)
combination of orbital compression and strabismus surgery
EXPERIMENTALorbital compression and strabismus surgery are performed at the same time
perform strabismus surgery after orbital compression
ACTIVE COMPARATORFirstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done.
Interventions
combination of orbital compression surgery and strabismus surgery at the same time
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- any previous disease in the study eye.
- any previous systematic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sun Yat-sen University
Study Record Dates
First Submitted
January 19, 2021
First Posted
June 9, 2021
Study Start
July 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
June 9, 2021
Record last verified: 2021-06