Eye Tracking Study on Eye Movement Function and Visual Attention Patterns in Patients With Thyroid-Associated Ophthalmopathy (TAO-A)

February 3, 2026 updated by: Ruili Wei, Shanghai Changzheng Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Changzheng hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TAO
Device: Non-invasive Eye Tracking Assessment

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:

  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.
CON
Device: Non-invasive Eye Tracking Assessment

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:

  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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Central Fixation Stability
Time Frame: Baseline
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.
Baseline
Gaze Distribution on Ocular Areas of Interest
Time Frame: Baseline
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.
Baseline
Extraocular Muscle (EOM) Thickness
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAO-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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