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NCT Number: NCT07381413

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

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.

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Key information

Conditions

Thyroid Associated Ophthalmopathies Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Eye Tracking Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive Eye Tracking Assessment

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Acronym: TAO-A

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 2, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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