Thyroid Associated OphthalmopathyNCT04919694
Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy
A study testing combination of orbital compression surgery and strabismus surgery and orbital compression in people with Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- What is being tested?
- combination of orbital compression surgery and strabismus surgery and orbital compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any previous disease in the study eye.
- any previous systematic disease
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy
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
Read the 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.
- Conditions
- Thyroid Associated Ophthalmopathy
- Being tested
- combination of orbital compression surgery and strabismus surgery, orbital compression
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of orbital compression surgery and strabismus surgeryProcedure or surgery
combination of orbital compression surgery and strabismus surgery at the same time
orbital compressionProcedure or surgery
orbital compression
| Study group | Role | What they receive |
|---|---|---|
| combination of orbital compression and strabismus surgery | Experimental | orbital compression and strabismus surgery are performed at the same time Receives: Procedure: combination of orbital compression surgery and strabismus surgery |
| perform strabismus surgery after orbital compression | Active comparator | Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done. Receives: Procedure: orbital compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
strabismus status
angle of deviation including up-gaze, down-gaze ,left and right-gaze
Measured: 6 weeks after surgery
strabismus status
angle of deviation including up-gaze, down-gaze ,left and right-gaze
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Associated OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919694
- Sponsor's protocol ID
- yanghs20210106
- Status last verified
- Jun 2021
- First submitted
- 19 Jan 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Combination of Orbital Compression Surgery and Strabismus Surgery in Patients With Moderate to Severe Thyroid Associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT04919694
- Acronym / sponsor ID
- yanghs20210106
- Conditions
- Thyroid Associated Ophthalmopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination of orbital compression and strabismus surgery | Experimental | Procedure: combination of orbital compression surgery and strabismus surgeryorbital compression and strabismus surgery are performed at the same time |
| perform strabismus surgery after orbital compression | Active comparator | Procedure: orbital compressionFirstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- any previous disease in the study eye.
- any previous systematic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of orbital compression surgery and strabismus surgerycombination of orbital compression surgery and strabismus surgery at the same time | Procedure or surgery | combination of orbital compression and strabismus surgery |
| orbital compressionorbital compression | Procedure or surgery | perform strabismus surgery after orbital compression |
Primary outcome
quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) .
Time frame: 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) .
Time frame: 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.
2 secondary outcomes
strabismus status
Time frame: 6 weeks after surgery
strabismus status
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of orbital compression surgery and strabismus surgery and orbital compression in people with Thyroid Associated Ophthalmopathy, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua sheng Yang, M.D,PHD (+8620-87331539, yanghs64@162.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life ,measured by GO-QoL(quality of life with Grave's Orbitopathy) . (time frame: 6 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.