Clinical Research Directory

Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease

Sponsor: University of Copenhagen

Summary

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.

Official title: Development of a Risk Prediction Model for Graves' Orbitopathy Using Systematic Ophthalmological Data and Inflammatory Metabolic Biomarkers in Patients With Newly Diagnosed Graves' Disease

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