Thyroid Eye DiseaseNCT04096612
The Therapeutic Effect of Dysthyroid Optic Neuropathy
A study testing Orbital decompression combined with MPT in people with Thyroid Eye Disease, run by Sun Yat-sen University at 1 site in China.
Trial summary
Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- Orbital decompression combined with MPT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months
Who cannot join
- With any serious systemic diseases With any surgery on eyes in six months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Opthalmic Center
Guangdong, Guangdong, 510060
Huasheng Yang, M.D., +8620-87331539, yanghs64@126.com
About this study
Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Dysthyroid optic neuropathy (DON) is the most serious complication of TAO, which can cause blurred vision, color vision and vision function damage, and affects the quality of life. Investigation of the therapeutic effect of orbital decompression may provide some clues to make the policy at treatment of DON. We explore the therapeutic effect of orbital decompression in patients with DON in both eyes.
- Conditions
- Thyroid Eye Disease
- Being tested
- Orbital decompression combined with MPT
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital decompression combined with MPTProcedure or surgery
Orbital decompression combined with MPT
| Study group | Role | What they receive |
|---|---|---|
| Orbital decompression combined MPT | Experimental | Orbital decompression was performed by the same doctor with rich clinical experience. MPT should be implemented in the patients with obvious thyroid disorder before orbital decompression surgery which should only be performed when thyroid function was stabilized. The surgery was performed under general anesthesia. An arcuate incision was made in the skin 2 mm below the lower eyelid margin, and the tissue under the incision were separated to the periorbita and orbital septum. Part of the medial orbital wall, inferior orbital wall and partial tissue of ethmoidal sinus were removed, and an appropriate amount of adipose tissue was excised. MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced. Receives: Procedure: Orbital decompression combined with MPT |
| Separate MPT | Experimental | MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced. Receives: Procedure: Orbital decompression combined with MPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
best corrected visual acuity in logMAR
Measured: 6 months
IOP
intraocular pressure in mmHg
Measured: 6 months
proptosis
proptosis in mm
Measured: 6 months
upper eyelid retraction
upper eyelid retraction in mm
Measured: 6 months
CAS
clinical activity score
Measured: 6 months
Secondary outcomes (2)
MD
mean deviation of visual field in dB
Measured: 6 months
PSD
pattern standard deviation of visual field in dB
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT04096612
- Sponsor's protocol ID
- yanghs2018
- Status last verified
- Sep 2019
- First submitted
- 27 Dec 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Dysthyroid Optic Neuropathy
- ClinicalTrials.gov ID
- NCT04096612
- Acronym / sponsor ID
- yanghs2018
- Conditions
- Thyroid Eye Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 20 Sep 2019 (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.
Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Dysthyroid optic neuropathy (DON) is the most serious complication of TAO, which can cause blurred vision, color vision and vision function damage, and affects the quality of life. Investigation of the therapeutic effect of orbital decompression may provide some clues to make the policy at treatment of DON. We explore the therapeutic effect of orbital decompression in patients with DON in both eyes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orbital decompression combined MPT | Experimental | Procedure: Orbital decompression combined with MPTOrbital decompression was performed by the same doctor with rich clinical experience. MPT should be implemented in the patients with obvious thyroid disorder before orbital decompression surgery which should only be performed when thyroid function was stabilized. The surgery was performed under general anesthesia. An arcuate incision was made in the skin 2 mm below the lower eyelid margin, and the tissue under the incision were separated to the periorbita and orbital septum. Part of the medial orbital wall, inferior orbital wall and partial tissue of ethmoidal sinus were removed, and an appropriate amount of adipose tissue was excised. MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced. |
| Separate MPT | Experimental | Procedure: Orbital decompression combined with MPTMPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months
Key exclusion criteria (1 listed)
- With any serious systemic diseases With any surgery on eyes in six months
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 |
|---|---|---|
| Orbital decompression combined with MPTOrbital decompression combined with MPT | Procedure or surgery | Orbital decompression combined MPT, Separate MPT |
Primary outcome
BCVA
Time frame: 6 months
best corrected visual acuity in logMAR
IOP
Time frame: 6 months
intraocular pressure in mmHg
proptosis
Time frame: 6 months
proptosis in mm
upper eyelid retraction
Time frame: 6 months
upper eyelid retraction in mm
CAS
Time frame: 6 months
clinical activity score
2 secondary outcomes
MD
Time frame: 6 months
PSD
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: Yes
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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 Orbital decompression combined with MPT in people with Thyroid Eye Disease, 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 1 inclusion and 1 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 20 Sep 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: 6 months). The study lists 5 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 20 Sep 2019.