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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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

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
Intervention / Treatment
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

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

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

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)

January 31, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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