Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT05429450
Eligibility Criteria:
Inclusion Criteria:
1. Bilateral moderate to severe thyroid associated orbitopathy.
2. Clinical Activity score (CAS) ≥ 3.
3. Duration of thyroid associated orbitopathy \< 2 years
Exclusion Criteria:
1. Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
2. Glaucoma patients or those known to be steroid responders
3. Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
4. Pregnancy
5. Previous orbital or lid surgeries
6. History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05429450
Study Brief:
Protocol Section:
NCT05429450