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NCT Number: NCT07124572

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

  1. eye morphological parameters

    Time frame: through study completion, average of 5 years

    Margin reflex distances(mm)

  2. Blinking feature of patients with thyroid-associated ophthalmopathy

    Time frame: through study completion, average of 5 years

    Blinking frequency

  3. Ocular movement measurement

    Time frame: through study completion, average of 5 years

    Ocular movement ability in nine gaze positions

  4. Automatic orbital structures segmentation and measurement using deep learning methods

    Time frame: through study completion, average of 5 years

    Automatic segmentation and measurement of orbital structures,such as eyeball, extraocular muscle, orbital fat, bony orbital region, optic nerves, etc

  5. Automatic diagnosis, grading, staging and prediction of patients with thyroid-associated ophthalmopathy

    Time frame: through study completion, average of 5 years

    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.

  6. three-dimensional eye parameters

    Time frame: through study completion, average of 5 years

    eyelid volume

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2022
Primary completion
2030
Study completion
2031
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

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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