Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
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- Who runs it
- University of Copenhagen
- Trial code
- NCT07812194
- Record updated
- 27 October 2026
- Original description
The aim of this observational study is to investigate why some people with newly diagnosed Graves' disease (GD) develop thyroid eye disease (TED), also known as Graves' orbitopathy, while others do not.Read full original descriptionShow less
Development of a Risk Prediction Model for Graves' Orbitopathy Using Systematic Ophthalmological Data and Inflammatory Metabolic Biomarkers in Patients With Newly Diagnosed Graves' Disease
The aim of this observational study is to investigate why some people with newly diagnosed Graves' disease (GD) develop thyroid eye disease (TED), also known as Graves' orbitopathy, while others do not.
The main questions the study aims to answer are:
1. What proportion of participants develop TED within one year of being diagnosed with GD? 2. Which early clinical signs, ophthalmological findings, blood biomarkers, tear-fluid biomarkers, or ocular surface microbiome characteristics are associated with an increased risk of developing thyroid eye disease?
Participants with newly diagnosed GD will attend two study visits, one at baseline and one approximately one year later. At each visit, participants will:
* Answer questions about their symptoms and quality of life * Undergo a standardized eye examination and have clinical photographs taken of their eyes * Provide blood samples, tear-fluid samples, and a small swab sample from the ocular surface
The study will also include healthy volunteers and participants with moderate-to-severe TED. Participants in these comparison groups will attend one study visit. Researchers will compare findings across the groups to better understand the early clinical and biological changes associated with thyroid eye disease.
The long-term aim is to improve the early detection and follow-up of people with GD who may be at increased risk of developing TED.
Inclusion: Newly Diagnosed Graves' Disease (GD) Cohort:; Age 18 years or older; Newly diagnosed GD; Positive TSH receptor antibodies, defined as TRAb >1.5 IU/L; Biochemical hyperthyroidism, defined as TSH <0.01 mIU/L; Residence in and/or clinical management within the Capital Region of Denmark, including Hvidovre Hospital, Rigshospitalet, Amager Hospital, Nordsjællands Hospital, Herlev Hospital, and Bispebjerg Hospital; Ability to provide oral and written informed consent; Healthy Control Group:; Age 18 years or older; No known history of GD; No previous positive TRAb measurement; No known thyroid dysfunction requiring antithyroid drug therapy or thyroid hormone replacement therapy; Ability to provide oral and written informed consent; Moderate-to-Severe Thyroid Eye Disease (TED) Group:; Age 18 years or older; Diagnosis of moderate-to-severe TED; Followed or treated in a relevant specialized clinical setting; Ability to provide oral and written informed consent.
Exclusion: Previous documented TRAb measurement >1.5 IU/L prior to the current diagnostic episode; Known Graves' disease or previous positive TRAb measurement; Known thyroid dysfunction requiring antithyroid drug therapy or thyroid hormone replacement therapy; Age below 18 years; Age below 18 years; Age below 18 years; Newly Diagnosed GD Cohort:; Inability to provide informed consent; Inability to complete the baseline assessment within the predefined study timeframe; Healthy Control Group:; Inability to provide informed consent; Moderate-to-Severe TED Group:; Inability to provide informed consent; Inability to complete the planned study assessment.