Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Thyroid-Associated Ophthalmopathy

Study type: Observational

Funder types: Other

Identifiers

NCT06585592

TAO3M-1

Details and patient eligibility

About

Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.

The aim of this clinical study is to:

1. Found characteristic changes from baseline to the end of treatment.
2. Identify characteristic changes associated with treatment response.
3. Construct a multimodal and multiparameter prediction model by characteristic changes.

Enrollment: 500 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• According to the Bartley criteria，diagnosed TAO from 2017/1/1 to 2024/3/31
• Moderate to severe patients defined by EUGOGO
• CAS ≥4 (on the 7-item scale) for the study eye
• Completed orbital MRI at our hospital
• Received complete medical treatment and completed assessment at our hospital

Exclusion criteria

• Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
• History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to < 1 g of methylprednisolone for the treatment of TAO.
• Any major illness/condition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
• Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study
• Pregnant or lactating
• Any other condition that,would impair the ability of the participant to undergo orbital MRI

Trial design

500 participants in 1 patient group

TAO