Thyroid Associated OphthalmopathyNCT07124572
Construction and Application of Precise Diagnosis and Treatment System for Thyroid-associated Ophthalmopathy
An observational study of Thyroid Associated Ophthalmopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to develop the deep learning-based system that integrates multimodal information to automatically diagnose, stage, and grade thyroid-associated ophthalmopathy (TAO), assist in treatment decision-making, and predict patient prognosis, thereby providing novel tools to support clinical management. Read more about this study
- Who is it for?
- Ages 7 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- What is being tested?
- Imaging and ocular examinations
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 500 patients with thyroid-associated ophthalomopahty 500 patients without thyroid-associated ophthalomopahty
Who may be able to join
- normal participants without eyelid disorders (control group)
- patients with thyroid-associated ophthalmopathy (TAO group)
- cooperative participants
Who cannot join
- participants with pupil or cornea disorders
- participants with history of eye injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Juan Ye
Hangzhou, Zhejiang, 310000
Juan Ye, +81-0571-87783897, yejuan@zju.edu.cn
About this study
This study aims to develop the deep learning-based system that integrates multimodal information to automatically diagnose, stage, and grade thyroid-associated ophthalmopathy (TAO), assist in treatment decision-making, and predict patient prognosis, thereby providing novel tools to support clinical management.
- Conditions
- Thyroid Associated Ophthalmopathy
- Being tested
- Imaging and ocular examinations
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging and ocular examinationsOther
2D and 3D Facial photography, blinking videos, orbital CT and MRI images, fundus images and images of nine gaze positions are taken.
Clinical information is recorded. Quality of life is assessed. Ocular examinations, such as visual acuity, levator function, exophthalmos measurement, strabismus test, visual field examination, axial length measurement, OCT, OCTA are made.
| Study group | Role | What they receive |
|---|---|---|
| Participants without Thyroid-associated ophthalmopathy | Participants without thyroid-associated ophthalmopathy based on Bartley criteria. Receives: Other: Imaging and ocular examinations | |
| Patients with Thyroid-associated ophthalmopathy | Patients diagnosed as thyroid-associated ophthalmopathy based on Bartley criteria. Receives: Other: Imaging and ocular examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye morphological parameters
Margin reflex distances(mm)
Measured: through study completion, average of 5 years
Blinking feature of patients with thyroid-associated ophthalmopathy
Blinking frequency
Measured: through study completion, average of 5 years
Ocular movement measurement
Ocular movement ability in nine gaze positions
Measured: through study completion, average of 5 years
Automatic orbital structures segmentation and measurement using deep learning methods
Automatic segmentation and measurement of orbital structures,such as eyeball, extraocular muscle, orbital fat, bony orbital region, optic nerves, etc
Measured: through study completion, average of 5 years
Automatic diagnosis, grading, staging and prediction of patients with thyroid-associated ophthalmopathy
Patients with thyroid-associated ophthalmopathy(TAO) are classified as TAO or non-TAO. Grading is classified as mild, moderate, severe and sight-threatening. Staging is classified as active and stable.
Measured: through study completion, average of 5 years
three-dimensional eye parameters
eyelid volume
Measured: through study completion, average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Oct 2022
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2031 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124572
- Sponsor's protocol ID
- 2022-0592
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of Precise Diagnosis and Treatment System for Thyroid-associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT07124572
- Acronym / sponsor ID
- 2022-0592
- Conditions
- Thyroid Associated Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 15 Aug 2025 (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.
This study aims to develop the deep learning-based system that integrates multimodal information to automatically diagnose, stage, and grade thyroid-associated ophthalmopathy (TAO), assist in treatment decision-making, and predict patient prognosis, thereby providing novel tools to support clinical management.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants without Thyroid-associated ophthalmopathy | – | Other: Imaging and ocular examinationsParticipants without thyroid-associated ophthalmopathy based on Bartley criteria. |
| Patients with Thyroid-associated ophthalmopathy | – | Other: Imaging and ocular examinationsPatients diagnosed as thyroid-associated ophthalmopathy based on Bartley criteria. |
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 patients with thyroid-associated ophthalomopahty 500 patients without thyroid-associated ophthalomopahty
Key inclusion criteria (3 listed)
- normal participants without eyelid disorders (control group)
- patients with thyroid-associated ophthalmopathy (TAO group)
- cooperative participants
Key exclusion criteria (2 listed)
- participants with pupil or cornea disorders
- participants with history of eye injury
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 |
|---|---|---|
| Imaging and ocular examinations2D and 3D Facial photography, blinking videos, orbital CT and MRI images, fundus images and images of nine gaze positions are taken. Clinical information is recorded. Quality of life is assessed. Ocular examinations, such as visual acuity, levator function, exophthalmos measurement, strabismus test, visual field examination, axial length measurement, OCT, OCTA are made. | Other | Participants without Thyroid-associated ophthalmopathy, Patients with Thyroid-associated ophthalmopathy |
Primary outcome
eye morphological parameters
Time frame: through study completion, average of 5 years
Margin reflex distances(mm)
Blinking feature of patients with thyroid-associated ophthalmopathy
Time frame: through study completion, average of 5 years
Blinking frequency
Ocular movement measurement
Time frame: through study completion, average of 5 years
Ocular movement ability in nine gaze positions
Automatic orbital structures segmentation and measurement using deep learning methods
Time frame: through study completion, average of 5 years
Automatic segmentation and measurement of orbital structures,such as eyeball, extraocular muscle, orbital fat, bony orbital region, optic nerves, etc
Automatic diagnosis, grading, staging and prediction of patients with thyroid-associated ophthalmopathy
Time frame: through study completion, average of 5 years
Patients with thyroid-associated ophthalmopathy(TAO) are classified as TAO or non-TAO. Grading is classified as mild, moderate, severe and sight-threatening. Staging is classified as active and stable.
three-dimensional eye parameters
Time frame: through study completion, average of 5 years
eyelid volume
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Associated Ophthalmopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Ye (+86-571-87783897, yejuan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eye morphological parameters (time frame: through study completion, average of 5 years). The study lists 6 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 15 Aug 2025.