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

NCT07124572 | Recruiting

• 1 other identifier: 2022-0592
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Associated Ophthalmopathy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Participants without Thyroid-associated ophthalmopathy

Participants without thyroid-associated ophthalmopathy based on Bartley criteria.

Other: Imaging and ocular examinations

Patients with Thyroid-associated ophthalmopathy

Patients diagnosed as thyroid-associated ophthalmopathy based on Bartley criteria.

Other: Imaging and ocular examinations

Interventions

Imaging and ocular examinations OTHER

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.

Participants without Thyroid-associated ophthalmopathy; Patients with Thyroid-associated ophthalmopathy

Eligibility Criteria

• Age: 7 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Juan Ye

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

X-Rays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Juan Ye

CONTACT

+86-571-87783897; yejuan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 15, 2025
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2031
• Last Updated: August 15, 2025

Record last verified: 2025-07

Locations

CN (1)