OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Vascular surface (micronm2)
研究概览
简要总结
The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.
详细描述
This quantification is based on the analysis of fractal dimension (FD, without unit), lacunarity (Lac, without unit), vascular density (VD,%) and surface area of choroidal neovascular ( CNV, mm2).
The fractal dimension of a vascular structure corresponds to its degree of complexity. Fractals are models found in nature and biological systems that show self-similarity at different magnifications. It is obtained from the "box counting" method calculating the number of vascular segments contained in squares of varied size. Normal retinal vessels have a known and quantified complexity (FD = 1.7).
A neovascular tumor treated with anti-angiogenics will reduce vascular density, losing its random architecture; the investigators observe a return to a model standardized. NVCs have a random organization. The lower the FD, the more random the vascular architecture.
Lacunarity represents the texture or the homogeneity of a lesion, this one is heterogeneous when it is little vascularized and homogeneous if the vascularization is very dense. The lower the lake, the more homogeneous the lesion.
FD and Lac are obtained in Angiography Optical Coherence Tomography (OCTA) by the analysis of the hypersignal detected on the cut of the external retina.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man / woman over 50,
- •Showing type 1 or type 2 CNV (choroidal neovessel) related to AMD during the second year of follow-up.
- •Acceptance to participate in the protocol
- •Affiliated to a social security scheme
排除标准
- •Type III CNV related to AMD,
- •Other cause of CNV
- •Signal less than 80 decibel and detachment of pigment epithelium (PED) greater than 250 μm on structural OCT B.
- •Protected Majors (Guardianship, Curator, Safeguard of Justice)
- •Participation in another interventional research.
- •Refusal to participate in the study
结局指标
主要结局
Vascular surface (micronm2)
时间窗: 12 months
Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.
Fractal lacunarity (without unit)
时间窗: 12 months
Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.
Fractal dimension (without unit)
时间窗: 12 months
Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.
Vascular density (%)
时间窗: 12 months
Analysis of vascular density measured by OCT-A on 4 consecutive examinations.
次要结局
- Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status(12 months)
- Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status(12 months)
- Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status(12 months)
- Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status(12 months)