About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Non-invasive Eye Tracking Assessment
DeviceThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
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.
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