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 the new diagnostic markers or imaging sequences. 2. Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.
According to the Bartley criteria，diagnosed TAO at our hospital after 2024/8/31
Moderate to severe patients defined by EUGOGO
CAS ≥3 (on the 7-item scale) for the study eye
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 investigator's 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 participant's participation in the study
Moderate to severe active TAO patients who receive medical treatment and assessment
Cohort
Prospective
Not listed
Percentage of participants with overall response
Percentage of participants with overall response
Percentage of participants with overall response
Percentage of participants with overall response
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Safety and Tolerability
Change of Serum Lipids parameters from baseline
including TG（mmol/L）、TC（mmol/L）、HDL（mmol/L）、LDL（mmol/L）
Change of Serum T3、T4 level from baseline
including T3（nmol/L）、T4（nmol/L）
Change of Serum TSH level from baseline
including TSH（mIU/L）
change of extraocular muscle volume and orbital fat volume by MRI
Change of Serum T-cell subgroup
including CD3（%）、CD3 absolute value、CD4（%）、CD4 absolute value、CD8（%）、CD8 absolute value、CD4/CD8（%）
Change of Serum T-cell subgroup
including CD3（%）、CD3 absolute value、CD4（%）、CD4 absolute value、CD8（%）、CD8 absolute value、CD4/CD8（%）
change of extraocular muscle volume and orbital fat volume by MRI
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