Assessment of Retinal Microcirculation in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA).
研究概览
简要总结
Type 1 diabetes mellitus (T1DM) is associated with an increased lifetime risk of developing diabetic retinopathy, a leading cause of visual impairment among working-age adults worldwide. Retinal assessment plays a pivotal role in the management of patients with T1DM, as the retina provides a unique, non-invasive window into the body's microvascular circulation. Early detection of retinal abnormalities is essential because structural and microvascular changes may develop years before the onset of vision-threatening diabetic retinopathy or visual symptoms. Contemporary retinal imaging techniques, enable the quantitative evaluation of retinal microvasculature allowing the identification of subclinical retinal damage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosis of Type 1 diabetes mellitus (T1DM) according to the American Diabetes Association (ADA) criteria.
- •Ability and willingness to provide written informed consent.
排除标准
- •Active uveitis or other intraocular inflammatory disease.
- •Uncontrolled glaucoma
- •High myopia (spherical equivalent refractive error >5.0 diopters)
- •History of ocular trauma.
- •History of intraocular surgery within the previous 6 months.
结局指标
主要结局
Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA).
时间窗: Vessel density will be assessed at baseline using OCTA. This is a cross-sectional study; no follow-up assessments will be performed. Participants will be evaluated at a single study visit and classified according to the stage of diabetic retinopathy.
次要结局
未报告次要终点
研究者
Irini Chatziralli
Assistant Professor in Ophthalmology, 2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece
University of Athens