Construction and Application of Precise Diagnosis and Treatment System for Thyroid-associated Ophthalmopathy

This study aims to develop the deep learning-based system that integrates multimodal information to automatically diagnose, stage, and grade thyroid-associated ophthalmopathy (TAO), assist in treatment decision-making, and predict patient prognosis, thereby providing novel tools to support clinical management.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Associated Ophthalmopathy
• Intervention / Treatment: Other: Imaging and ocular examinations

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Juan Ye; Phone Number: +86-571-87783897; Email: yejuan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Juan Ye
      • Contact: Juan Ye; Phone Number: +81-0571-87783897; Email: yejuan@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

500 patients with thyroid-associated ophthalomopahty 500 patients without thyroid-associated ophthalomopahty

Description

Inclusion Criteria:

• normal participants without eyelid disorders (control group)
• patients with thyroid-associated ophthalmopathy (TAO group)
• cooperative participants

Exclusion Criteria:

• participants with pupil or cornea disorders
• participants with history of eye injury

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants without Thyroid-associated ophthalmopathy; Participants without thyroid-associated ophthalmopathy based on Bartley criteria.	Other: Imaging and ocular examinations; 2D and 3D Facial photography, blinking videos, orbital CT and MRI images, fundus images and images of nine gaze positions are taken. Clinical information is recorded. Quality of life is assessed. Ocular examinations, such as visual acuity, levator function, exophthalmos measurement, strabismus test, visual field examination, axial length measurement, OCT, OCTA are made.
Patients with Thyroid-associated ophthalmopathy; Patients diagnosed as thyroid-associated ophthalmopathy based on Bartley criteria.	Other: Imaging and ocular examinations; 2D and 3D Facial photography, blinking videos, orbital CT and MRI images, fundus images and images of nine gaze positions are taken. Clinical information is recorded. Quality of life is assessed. Ocular examinations, such as visual acuity, levator function, exophthalmos measurement, strabismus test, visual field examination, axial length measurement, OCT, OCTA are made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eye morphological parameters	Margin reflex distances(mm)	through study completion, average of 5 years
Blinking feature of patients with thyroid-associated ophthalmopathy	Blinking frequency	through study completion, average of 5 years
Ocular movement measurement	Ocular movement ability in nine gaze positions	through study completion, average of 5 years
Automatic orbital structures segmentation and measurement using deep learning methods	Automatic segmentation and measurement of orbital structures,such as eyeball, extraocular muscle, orbital fat, bony orbital region, optic nerves, etc	through study completion, average of 5 years
Automatic diagnosis, grading, staging and prediction of patients with thyroid-associated ophthalmopathy	Patients with thyroid-associated ophthalmopathy(TAO) are classified as TAO or non-TAO. Grading is classified as mild, moderate, severe and sight-threatening. Staging is classified as active and stable.	through study completion, average of 5 years
three-dimensional eye parameters	eyelid volume	through study completion, average of 5 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: August 6, 2025
• First Submitted That Met QC Criteria: August 13, 2025
• First Posted (Estimated): August 15, 2025

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Eye Diseases; Graves Ophthalmopathy
• Other Study ID Numbers: 2022-0592

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No