Multi-modal Medical Images for Extraocular Muscle Fibrosis Assessment

NCT07056114 | Completed DMC

• 1 other identifier: No.21JCYBJC01660
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the elasticity of the extraocular muscles in different stages of thyroid eye disease and to examine the correlation of MRI parameters (native T1 value and ECV) and elasticity for the assessment of extraocular muscles fibrosis in the thyroid eye disease.

Conditions

Thyroid Eye Disease, TED

Keywords

Thyroid eye disease; Real-time tissue elastography

Outcome Measures

Primary Outcomes (1)

• MRI parameters (native T1 value and ECV) and elasticity of EOMs in the TED.

  Consecutive patients with moderate-to-severe TED were retrospectively enrolled from Tianjin Eye Hospital between 2020 and 2024. All patients underwent MR with T1 mapping and RTE. The patients were categorized into either the active or inactive TED

Study Arms (2)

patients group

Consecutive patients with moderate-to-severe TED

Other: The patients with active or inactive TED

control group

The sex-matched control group comprised healthy individuals and patients with orbital symptoms but normal findings on orbital MRI

Interventions

The patients with active or inactive TED OTHER

The patients were categorized into either the active or inactive TED group based on the Clinical Activity Score

patients group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Design and Participants Consecutive patients (n=40) with moderate-to-severe TED were retrospectively enrolled from Tianjin Eye Hospital between 2020 and 2024. All patients underwent MR with T1 mapping and RTE. The patients were categorized into either the active or inactive TED group based on the Clinical Activity Score (CAS). The sex-matched control group (n=18) comprised healthy individuals and patients with orbital symptoms but normal findings on orbital MRI. All participants underwent a comprehensive ophthalmic examination, including slit-lamp biomicroscopy, Hertel exophthalmometry and intraocular pressure. A blood sample was obtained on the day of MR scanning to measure hematocrit.

You may qualify if:

• Consecutive patients with moderate-to-severe TED were retrospectively enrolled from Tianjin Eye Hospital between 2020 and 2024.

You may not qualify if:

• Participants who reported any of the following were excluded: (1) any ophthalmopathies (e.g., glaucoma, diabetic retinopathy and optic nerve disorders); (2) patients with dysthyroid optic neuropathy (DON).

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Exercise

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: January 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)