Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease

NCT07480720 | Recruiting

• 1 other identifier: FSCH-2026-24-07
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graves Disease; Graves Ophthalmopathy

Keywords

Graves disease; Thyroid autoimmunity; Systemic inflammation; Optical coherence tomography; Retinal nerve fiber layer; Graves ophthalmopathy

Outcome Measures

Primary Outcomes (2)

• Peripapillary Retinal Nerve Fiber Layer Thickness

  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

  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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elaziğ, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Graves Disease; Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

SİNEM KESER, MD

CONTACT

+905070646384; kesersinem@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

TU (1)