NCT07381413

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026May 2029

First Submitted

Initial submission to the registry

January 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

January 25, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

TAOeye tracking

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (3)

  • Central Fixation Stability

    Baseline

  • Gaze Distribution on Ocular Areas of Interest

    Baseline

  • Extraocular Muscle (EOM) Thickness

    Baseline

Study Arms (2)

TAO

Device: Non-invasive Eye Tracking Assessment

CON

Device: Non-invasive Eye Tracking Assessment

Interventions

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.

CONTAO

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changzheng Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Ophthalmology

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations