Thyroid-associated ophthalmopathy (TAO), known as Graves' ophthalmopathy (GO), is an inflammatory orbital disease linked to thyroid disorders, affecting 25%-40% of Graves' disease (GD) cases. TAO presents with symptoms such as eyelid retraction, exophthalmos, diplopia, restrictive strabismus, exposure keratopathy, and optic neuropathy. The Bartley criteria, including eyelid retraction, thyroid dys
Conditions
Interventions
control group:Ophthalmic parameter measurement
experimental group:Test device measurements
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: TED subjects must meet all of the following inclusion criteria: 1. Age 18-70 years, regardless of gender; 2. Meet the diagnostic criteria for thyroid-associated ophthalmopathy; 3. Able to fully understand and voluntarily sign the informed consent form; Healthy subjects must meet all of the following inclusion criteria: 1. Age 18-70 years, regardless of gender; 2. No history of ophthalmic diseases, including appearance, structural, or functional abnormalities such as high myopia, ocular trauma, or history of ophthalmic surgery; 3. Able to fully understand and voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they meet any of the following criteria: 1. History of severe diseases in the cardiovascular, hepatic, renal, digestive, hematologic, neurological, or psychiatric systems; 2. Any condition that, in the physician’s judgment, would prevent successful participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Inter-Observer Repeatability in Measuring Ocular Proptosis Using the Experimental Device and Control Method; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events and Serious Adverse Events;Device Defects;Evaluation of Inter-Observer Repeatability in Measuring Palpebral Fissure Width Between the Experimental Device and Control Method.;Evaluation of Inter-Observer Repeatability and Inter-Group Consistency in Measuring Conjunctival Hyperemia Percentage and Ocular Motility Using the Experimental Device and Control Method.;Evaluation of Inter-Group Consistency in Measuring Ocular Proptosis and Palpebral Fissure Width Using the Experimental Device and Control Method;Evaluation of Intra-Observer Repeatability in Measuring Ocular Proptosis, Palpebral Fissure Width, Conjunctival Hyperemia Percentage, and Ocular Motility Using the Experimental Device and Control Method.;Performance of the Experimental Device for Measuring Ophthalmic Parameters.; | — |
Countries
China
Contacts
Public ContactWeiqing Wang
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed