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RecruitingNCT07480720Updated Mar 18, 2026

Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease

An observational study in Graves Disease and Graves Ophthalmopathy, sponsored by Elazıg Fethi Sekin Sehir Hastanesi. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Elazıg Fethi Sekin Sehir Hastanesi · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Graves Disease
  • Graves Ophthalmopathy

Keywords

  • Graves disease
  • Thyroid autoimmunity
  • Systemic inflammation
  • Optical coherence tomography
  • Retinal nerve fiber layer
  • Graves ophthalmopathy
03

In context

Graves Disease

150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's planned enrollment of 100 is close to the median of 110 across 57 observational studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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)

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Peripapillary Retinal Nerve Fiber Layer Thickness

    Evaluation and comparison of peripapillary retinal nerve fiber layer thickness values in different quadrants among study groups.

    Time frame: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026

  2. 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.

    Time frame: Retrospective evaluation of OCT measurements obtained between August 2018 and January 2026

07

Study locations

1 of 1 sites recruiting
  • Fethi Sekin City Hospital
    Elâzığ, Elaziğ, Turkey (Türkiye)
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07480720
Lead sponsor
Elazıg Fethi Sekin Sehir Hastanesi
Responsible party
Sinem Keser (Principal Investigator, Elazıg Fethi Sekin Sehir Hastanesi) — Principal investigator
First posted
Mar 18, 2026
Start date
Mar 1, 2026
Primary completion
Apr 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

SİNEM KESER, MD
Contact
kesersinem@hotmail.com
+905070646384

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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