Retinal Neurodegenerative and Vascular Changes in Diabetic Patients: an OCT-based Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Correlation between choroid and outer retina using SD-OCT- based binarization technique
研究概览
简要总结
Using Optical Coherence Tomography and ImageJ software the investigators will analyze retinal and choroidal vascular changes and their impact on retinal layers among patients with diabetes without retinopathy and patients with diabetes and retinopathy.
详细描述
Relieving the burden of diabetic retinopathy treatment require a prompt and non-invasive assessment of diabetic patients before the occurence of diabetic retinopathy. Since OCT is capable of imaging retina with such a high precision, retinal changes occuring before any clinical signs of retinopathy, such as microaneurysm or haemorrhages, can now be assessed. In the present study the investigators are analyzing the connection between retinal arteries and veins regarding lumen diameter, vessel wall thickness and their correlation with retinal nerve fiber layer and ganglion cell layer thickness. Moreover, using binarization of the choroid the investigators will assess its relationship with outer retina layers, such as retinal pigment epithelium and photoreceptors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •history of type 1DM for more than 1 year
- •history of type 2 DM for more than 3 months
- •diagnosis of no DR or mild Non-proliferative diabetic retinopathy(NPDR)
排除标准
- •DR with more than NPDR ,
- •Diabetic macular oedema,
- •media opacities such as corneal or lens opacities that could preclude appropriate OCT imaging,
- •presence of other retinal diseases such as Age-related macular degeneration, Vitreo-macular traction, Macular hole, Epiretinal membrane, Retinal vein occlusion, Macular scars,
- •Glaucoma, Optic neuropathies or Neurodegenerative diseases,
- •history of ocular trauma,
- •Refractive errors of more than ±6 diopters (spherical equivalent),
- •previous ocular surgery, focal laser, panretinal photocoagulation or anti-VEGF intravitreal injection
结局指标
主要结局
Correlation between choroid and outer retina using SD-OCT- based binarization technique
时间窗: 2018-2019
starting from EDI-OCT scans the investigators will analyze choroidal parameters such as Luminal area, Stromal area, Total choroidal area, Chorodial vascularity index and correlate them with retinal pigment epithelium (RPE),outer nuclear layer(ONL) and photoreceptors' thickness (PR)
Correlation between neurodegeneration and retinal vessels characteristics
时间窗: 2018-2019
using full width at half maximum method, the investigators will measure peripapillary arteries and veins' diameters, their wall thickness and correlate them with RNFL and ganglion cell layer(GCL) thickness
次要结局
- Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)(2018-2019)
- Correlation between renal function and choroidal parameters(2018-2019)
- Correlation between choroidal parameters and diabetes control(2018-2019)
- Correlation between sistemic factors and choroidal parameters(2018-2019)
研究者
Ioana Damian
Assistant Professor
Iuliu Hatieganu University of Medicine and Pharmacy