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临床试验/NCT07480720
NCT07480720招募中不适用

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

Elazıg Fethi Sekin Sehir Hastanesi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Peripapillary Retinal Nerve Fiber Layer Thickness

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

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.

结局指标

主要结局

Peripapillary Retinal Nerve Fiber Layer Thickness

时间窗: 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.

Macular Thickness Measured by Optical Coherence Tomography

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Elazıg Fethi Sekin Sehir Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sinem Keser

Principal Investigator

Elazıg Fethi Sekin Sehir Hastanesi

研究点 (1)

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