Prevention of Onset and Transition to an Advanced Form of Diabetic Retinopathy in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Vascular density in central and peripheral retina - healthy subjects
研究概览
简要总结
The primary goal of the project is to create a normative database from data collected from a healthy pediatric population. A secondary aim is to compare normative data with data from pediatric patients with pre-existing type 1 diabetes mellitus.
详细描述
Diabetic retinopathy, or damage to the retina caused by diabetes, is one of the most common complications in all patients with newly diagnosed diabetes mellitus of both types. These are mainly pathological changes affecting the vascular supply of the retina, which precede changes affecting the peripheral nervous system.
Children and in general patients with type I diabetes mellitus are around 0.6% of the population in the long term. the first changes in the retinal vessels can usually be expected after 2-5 years from the first detection of the disease. These changes are diagnosed using a biomicroscopic examination of the fundus.
Until recently, the only possible examination method was fluorescein angiography (FAG). It is an invasive examination with a fluorescein solution administered into a peripheral vein through a cannula and further photo documentation of the flow dynamics through the vascular bed in blue (cobalt) light. The flow time in individual phases of filling is recorded.
The disadvantage is the necessary cooperation of the child, the need to establish peripheral venous access, the risk of an allergic reaction to the contrast material, and the duration of the examination lasting two or more hours.
These disadvantages disappeared with the advent of optical coherence tomography and the angiographic mode - OCTA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •emmetropia
- •slight refractive error
- •best-corrected visual acuity equal to or better than 6/6 Schnellen optotypes
排除标准
- •general disease that by its nature affects or can affect the retina and the vascular system of the eye
- •concomitant vascular or other retinal diseases
研究组 & 干预措施
Children with diabetes mellitus
Children with diabetes mellitus will undergo optical coherence tomography.
干预措施: Optical coherence tomography (OCTA) (Diagnostic Test)
Healthy pediatric patients
Healthy pediatric patients will undergo optical coherence tomography.
干预措施: Optical coherence tomography (OCTA) (Diagnostic Test)
结局指标
主要结局
Vascular density in central and peripheral retina - healthy subjects
时间窗: 3 years
The primary goal of the project is measurement of vascular density in central and peripheral retina in healthy subjects using OCT Spectralis (Heidelberg Engineering, Germany). Vascular density is ratio between areas with and without vascular tissue. Data will be analysed by ImageJ software (National Institutes of Health, USA). Normative data will be collected from healthy individuals 6-15 years old.
次要结局
- Vascular density in central and peripheral retina - diabetic patients(3 years)