Optic Nerve Head Evaluation Through Multimodal Blood Flow Analysis: a Prospective Observational, Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Parameters correlated to the development and progression (prognostic biomarkers) of the diseases.
研究概览
简要总结
OCT-A and eco-colordoppler are technologies which enable optic nerve head (ONH) blood perfusion detection. The aim of the study is to assess ONH vascular and structural components in optic neuropathies with and without ONH edema or pseudo-edema with OCT-A, and analyze ONH blood-flow with eco-colordoppler.
详细描述
BACKGROUND AND RATIONALE The vascular component of the ONH, like that of the retina, is an essential part for the ONH homeostasis, but is considered difficult to be precisely analyzed, especially in optic nerve pathologies. Little is known about the vascular component and its role in both acute and chronic ONH diseases, particularly in conditions that cause swelling, where it is mandatory to differentiate edema from pseudo-edema.
Today, the gold standard for the vascular imaging of the retina is angiography, using either fluorescein or indocyanine green. However, conventional angiography has the disadvantage that the invasive administration of dye into the venous system is required, leading to low but potentially life-threatening side effects as allergic reactions; furthermore, data obtained are not standardizable or exploitable for a quantitative analysis. However, new technologies such as OCT-A can provide standardizable and quantifiable data on vascular structures that can be used in a statistical analysis. Additionally, eco-colordoppler ultrasound provides direct measurements of ONH blood-flow.
OBJECTIVES AND ENDPOINTS Objectives Endpoints: The aim of the study is to assess ONH vascular and structural components optic neuropathies with and without ONH edema or pseudo-edema through OCT-A (OCT-angiography) and ocular blood-flow through eco-colordoppler.
Primary Objective: to identify parameters correlated to the development and progression (prognostic biomarkers) of the diseases.
Primary Endpoint: Analysis of data collected in symptomatic and asymptomatic eyes, obtained through OCT-A in order to evaluate the relationship between functional and structural parameters in order to identify parameters correlated to the development and progression of the diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant (or parents/legal representative/tutor for minors) is willing and able to give informed consent for participation in the study
- •patients affected by acute ONH edema (NAION, papilledema, optic neuritis)
- •patients affected by acute pseudoedema (LHON)
- •patients affected by chronic pseudoedema (LHON, ODD)
- •patients affected by chronic ONH neuropathies (NTG, DOA, WS) non- affected eyes in each optic neuropathy patient
排除标准
- •any other ONH disease or neurological /retinal disease impairing the evaluation of the ONH;
- •evidence of media opacities affecting the quality of the vascular assessment;
- •patients affected Alzheimer/Parkinson disease will be considered separately
结局指标
主要结局
Parameters correlated to the development and progression (prognostic biomarkers) of the diseases.
时间窗: 24 months
Analysis of data collected in symptomatic and asymptomatic eyes, obtained through OCT-A in order to evaluate the relationship between functional and structural parameters in order to identify parameters correlated to the development and progression of the diseases.
次要结局
- To assess and compare different ONH vascular components through OCT-A and eco-colordoppler in order to identify parameters correlated to the diseases.(24 Months)
研究者
Barboni
MD
IRCCS San Raffaele