- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07480720
Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease
Relationship Between Systemic Inflammation, Thyroid Autoimmunity, and Neuroretinal Structures in Graves Disease
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: SİNEM KESER, MD
- Phone Number: +905070646384
- Email: kesersinem@hotmail.com
Study Locations
-
-
Elaziğ
-
Elâzığ, Elaziğ, Turkey (Türkiye)
- Recruiting
- Fethi Sekin City Hospital
-
Contact:
- SİNEM KESER, MD
- Phone Number: +905070646384
- Email: kesersinem@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will consist of adult patients diagnosed with Graves' disease who are followed in the endocrinology and ophthalmology clinics of the participating institution. Patients who meet the inclusion criteria and have available optical coherence tomography (OCT) measurements and laboratory data will be included in the patient group.
The control group will consist of age- and sex-matched healthy volunteers without a history of thyroid disease or ocular pathology, recruited from individuals undergoing routine ophthalmologic examination.
All participants will be evaluated for neuroretinal structural parameters using OCT and systemic inflammatory markers obtained from laboratory tests.
Description
Inclusion Criteria:
- Age ≥ 18 years
Diagnosis of Graves' disease (for the patient group)
No known thyroid disease in healthy control participants
Availability of optical coherence tomography (OCT) measurements and laboratory data
Time interval between OCT examination and blood sampling ≤ 10 days
Exclusion Criteria:
- Presence of glaucoma, optic neuropathy, or retinal vascular diseases
Macular diseases, uveitis, or severe refractive error (high myopia >6 diopters)
Diabetic retinopathy
History of previous intraocular surgery
History of active infection, malignancy, or systemic inflammatory disease
Poor-quality OCT measurements (segmentation errors or low signal strength)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy Controls
Age-matched healthy individuals without known thyroid disease or autoimmune disorders who underwent ophthalmologic examination and optical coherence tomography evaluation.
|
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Graves Disease Without Ophthalmopathy
Patients diagnosed with Graves disease who do not have clinical signs of Graves ophthalmopathy and who underwent optical coherence tomography evaluation.
|
|
Graves Disease With Ophthalmopathy
Patients diagnosed with Graves disease who have clinical findings consistent with Graves ophthalmopathy and who underwent optical coherence tomography evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripapillary Retinal Nerve Fiber Layer Thickness
Time Frame: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
|
Evaluation and comparison of peripapillary retinal nerve fiber layer thickness values in different quadrants among study groups.
|
Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
|
|
Macular Thickness Measured by Optical Coherence Tomography
Time Frame: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
|
Comparison of macular thickness measurements among healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy.
|
Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Genetic Diseases, Inborn
- Autoimmune Diseases
- Immune System Diseases
- Eye Diseases
- Eye Diseases, Hereditary
- Exophthalmos
- Orbital Diseases
- Goiter
- Hyperthyroidism
- Thyroid Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Graves Ophthalmopathy
- Graves Disease
Other Study ID Numbers
- FSCH-2026-24-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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