Thyroid Associated OphthalmopathiesTAO-ANCT07381413
Eye Tracking Study on Eye Movement Function and Visual Attention Patterns in Patients With Thyroid-Associated Ophthalmopathy
An observational study of Thyroid Associated Ophthalmopathies and Eye Tracking, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This study focuses on eye health and visual function in patients with Thyroid-Associated Ophthalmopathy (TAO), a condition that often causes bulging eyes and restricted eye movement. The purpose of this study is to use non-invasive eye-tracking technology to evaluate how the disease affects eye movement function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Associated Ophthalmopathies, Eye Tracking
- What is being tested?
- Non-invasive Eye Tracking Assessment
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to May 2029
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Thyroid-Associated Ophthalmopathy (TAO) group will consist of consecutive patients presenting to the clinic who are diagnosed with TAO according to the 2022 Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Associated Ophthalmopathy. The healthy control group will be recruited through hospital staff volunteers and community advertisements.
Who may be able to join
- Aged between 18 and 70 years, inclusive.
- Willing and able to provide written informed consent.
- Best-corrected visual acuity (BCVA) ≥ 1.0 in both eyes, with no history of ocular diseases or thyroid disorders.
Who cannot join
- Non-TAO Ocular Motility Disorders: History of conditions like myasthenia gravis, cranial nerve palsy, or congenital strabismus.
- Neurological Diseases: Disorders affecting oculomotor control (e.g., Parkinson's, MS, stroke, or brain tumors).
- Significant Visual Impairment: BCVA < 0.5 due to media opacities or retinopathy, preventing clear visualization of stimuli.
- Prior Ocular Surgery: History of surgeries affecting extraocular muscle mechanics (e.g., strabismus surgery, scleral buckling).
- Psychiatric or Cognitive Disorders: Inability to follow instructions or conditions affecting eye movements (e.g., schizophrenia).
- Medication Interference: Use of drugs affecting reaction time (e.g., sedatives) within 48 hours of testing.
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
Changzheng Hospital
Shanghai
Chunhui Yang, 021-66540109, 1633810781@qq.com
About this study
This study focuses on eye health and visual function in patients with Thyroid-Associated Ophthalmopathy (TAO), a condition that often causes bulging eyes and restricted eye movement. The purpose of this study is to use non-invasive eye-tracking technology to evaluate how the disease affects eye movement function. The investigators hypothesize that compared to healthy individuals, patients with TAO will show measurable differences in eye stability and the ability to track moving objects. Additionally, the investigators believe the disease may alter how patients visually scan faces (e.g., avoiding eye contact). The study will enroll 100 participants, including both patients and healthy volunteers. By recording gaze patterns while participants look at a screen, the investigators aim to objectively quantify the physical and social impact of the disease, providing better data for future treatment plans.
- Conditions
- Thyroid Associated Ophthalmopathies, Eye Tracking
- Being tested
- Non-invasive Eye Tracking Assessment
- Keywords
- TAO, eye tracking
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Eye Tracking AssessmentDevice
This is an observational study; no therapeutic intervention is administered. All participants undergo a single, standardized study visit that includes:
Participants will undergo a visual function assessment using a desktop-based high-frequency eye tracker. The assessment consists of three parts:
- Calibration: To ensure accurate gaze tracking.
- Oculomotor Tasks: Participants track visual targets to measure fixation stability and smooth pursuit capabilities.
- Visual Attention Tasks: Participants view static images to record scanning patterns.
The entire process is non-invasive and lasts approximately 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| TAO | Not described Receives: Device: Non-invasive Eye Tracking Assessment | |
| CON | Not described Receives: Device: Non-invasive Eye Tracking Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smooth Pursuit Function Gaze Distribution
Participants track a moving target on the screen. This metric quantifies the spatial distribution of fixation points recorded throughout the task duration
Measured: Baseline
Secondary outcomes (3)
Central Fixation Stability
This outcome measures the participant's ability to maintain a steady gaze on a central target for a predefined duration. It is quantified by the percentage of fixation time remaining within a small predefined area around the target center.
Measured: Baseline
Gaze Distribution on Ocular Areas of Interest
This metric analyzes the visual attention patterns when viewing images.This is used to evaluate potential social-visual avoidance or altered scanning strategies in TAO patients compared to healthy controls.
Measured: Baseline
Extraocular Muscle (EOM) Thickness
The thickness of the extraocular muscles (including the medial, lateral, superior, and inferior rectus). This anatomical metric serves as a biological marker of disease severity and will be correlated with eye-tracking functional data to explore the relationship between muscle hypertrophy and movement impairment.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start31 Jan 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Associated OphthalmopathiesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruili Wei, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381413
- Sponsor's protocol ID
- TAO-A
- Acronym
- TAO-A
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang C, Shen Y, Song J, Chen Y, Zeng C, Wei R. Clinically accessible eye-tracking in thyroid-associated ophthalmopathy: exploratory classification modeling and gaze allocation to disease-related periocular images. BMC Ophthalmol. 2026 Jun 22. doi: 10.1186/s12886-026-05055-6. Online ahead of print.
PubMed 42332638
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Tracking Study on Eye Movement Function and Visual Attention Patterns in Patients With Thyroid-Associated Ophthalmopathy
- ClinicalTrials.gov ID
- NCT07381413
- Acronym / sponsor ID
- TAO-A / TAO-A
- Conditions
- Thyroid Associated Ophthalmopathies, Eye Tracking
- Keywords
- TAO, eye tracking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 2 Feb 2026 (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 focuses on eye health and visual function in patients with Thyroid-Associated Ophthalmopathy (TAO), a condition that often causes bulging eyes and restricted eye movement. The purpose of this study is to use non-invasive eye-tracking technology to evaluate how the disease affects eye movement function. The investigators hypothesize that compared to healthy individuals, patients with TAO will show measurable differences in eye stability and the ability to track moving objects. Additionally, the investigators believe the disease may alter how patients visually scan faces (e.g., avoiding eye contact). The study will enroll 100 participants, including both patients and healthy volunteers. By recording gaze patterns while participants look at a screen, the investigators aim to objectively quantify the physical and social impact of the disease, providing better data for future treatment plans.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAO | – | Device: Non-invasive Eye Tracking Assessment |
| CON | – | Device: Non-invasive Eye Tracking Assessment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Thyroid-Associated Ophthalmopathy (TAO) group will consist of consecutive patients presenting to the clinic who are diagnosed with TAO according to the 2022 Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Associated Ophthalmopathy. The healthy control group will be recruited through hospital staff volunteers and community advertisements.
Key inclusion criteria (3 listed)
- Aged between 18 and 70 years, inclusive.
- Willing and able to provide written informed consent.
- Best-corrected visual acuity (BCVA) ≥ 1.0 in both eyes, with no history of ocular diseases or thyroid disorders.
Key exclusion criteria (6 listed)
- Non-TAO Ocular Motility Disorders: History of conditions like myasthenia gravis, cranial nerve palsy, or congenital strabismus.
- Neurological Diseases: Disorders affecting oculomotor control (e.g., Parkinson's, MS, stroke, or brain tumors).
- Significant Visual Impairment: BCVA < 0.5 due to media opacities or retinopathy, preventing clear visualization of stimuli.
- Prior Ocular Surgery: History of surgeries affecting extraocular muscle mechanics (e.g., strabismus surgery, scleral buckling).
- Psychiatric or Cognitive Disorders: Inability to follow instructions or conditions affecting eye movements (e.g., schizophrenia).
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 |
|---|---|---|
| Non-invasive Eye Tracking AssessmentThis is an observational study; no therapeutic intervention is administered. All participants undergo a single, standardized study visit that includes: Participants will undergo a visual function assessment using a desktop-based high-frequency eye tracker. The assessment consists of three parts: 1. Calibration: To ensure accurate gaze tracking. 2. Oculomotor Tasks: Participants track visual targets to measure fixation stability and smooth pursuit capabilities. 3. Visual Attention Tasks: Participants view static images to record scanning patterns. The entire process is non-invasive and lasts approximately 15-20 minutes. | Device | CON, TAO |
Primary outcome
Smooth Pursuit Function Gaze Distribution
Time frame: Baseline
Participants track a moving target on the screen. This metric quantifies the spatial distribution of fixation points recorded throughout the task duration
3 secondary outcomes
Central Fixation Stability
Time frame: Baseline
Gaze Distribution on Ocular Areas of Interest
Time frame: Baseline
Extraocular Muscle (EOM) Thickness
Time frame: Baseline
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 6 Feb 2026.
- Derived from this study: PubMed 42332638Yang C, Shen Y, Song J, Chen Y, Zeng C, Wei R. Clinically accessible eye-tracking in thyroid-associated ophthalmopathy: exploratory classification modeling and gaze allocation to disease-related periocular images. BMC Ophthalmol. 2026 Jun 22. doi: 10.1186/s12886-026-05055-6. Online ahead of print.
- Individual participant dataSharing planned: No
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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 Ophthalmopathies and Eye Tracking, run by Shanghai Changzheng Hospital 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 6 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 6 Feb 2026. 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?
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?
Smooth Pursuit Function Gaze Distribution (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381413, which also lists 1 linked publication.
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 6 Feb 2026.