RecruitingNCT06590220

Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy

Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy


Sponsor

Shanghai Changzheng Hospital

Enrollment

150 participants

Start Date

Oct 9, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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

Exclusion Criteria7

  • 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
  • Pregnant or lactating
  • Any other condition that,would impair the ability of the participant to undergo orbital MRI
  • Incomplete information

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Locations(1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

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NCT06590220


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