Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease

March 14, 2026 updated by: Sinem Keser, Elazıg Fethi Sekin Sehir Hastanesi

Relationship Between Systemic Inflammation, Thyroid Autoimmunity, and Neuroretinal Structures in Graves Disease

This retrospective observational study aims to evaluate the relationship between systemic inflammatory parameters, thyroid autoimmunity markers, and neuroretinal structures in patients with Graves disease. Medical records of patients diagnosed with Graves disease and healthy control subjects evaluated at Elazığ Fethi Sekin City Hospital between August 2018 and January 2026 will be reviewed. Optical coherence tomography (OCT) measurements, including macular thickness and peripapillary retinal nerve fiber layer (RNFL) thickness, will be analyzed. Laboratory parameters such as complete blood count-derived inflammatory indices, C-reactive protein, thyroid function tests, and thyroid autoantibodies will also be recorded. The study will compare neuroretinal parameters between healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy, and will investigate potential associations between systemic inflammation, thyroid autoimmunity, and neuroretinal structural changes.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

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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