NCT07725055尚未招募不适用
AOSLO Imaging for the Study of Cellular Alterations in Retinal Neurodegeneration
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts0 个研究点目标入组 260 人开始时间: 2026年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 主要终点
- Proportion of images obtained with the MONA system deemed usable for the analysis of retinal microstructures.
研究概览
简要总结
Primary objective:
- Acquisition and analysis of images for non-medical purposes using the MONA IV system, an adaptive-optics-corrected scanning ophthalmoscope.
Secondary objectives:
- To measure the reproducibility of assessments;
- To evaluate the detection of progressive changes.
详细描述
Patients:
- 100 subjects aged 10 to 79 years with a condition that may affect the inner retina (e.g., glaucoma, optic neuropathy, etc.)
- 100 subjects aged 10 to 80 years with a condition that may affect the outer retina (e.g., AMD, retinitis pigmentosa, etc.)
- Male or female
- Covered by health insurance
Healthy volunteers:
- 30 subjects aged over 50 and under 80
- 30 subjects aged over 18 and under 50
- Male or female
- Healthy subjects with no known condition that directly or indirectly affects the structure of the eye
- Covered by health insurance
For all subjects:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •100 subjects aged 10 to 79 years with a condition that may affect the inner retina (e.g., glaucoma, optic neuropathy, etc.)
- •100 subjects aged 10 to 80 years with a condition that may affect the outer retina (e.g., AMD, retinitis pigmentosa, etc.)
- •Male or female
- •Covered by health insurance
- •Healthy volunteers:
- •30 subjects aged over 50 and under 80
- •30 subjects aged over 18 and under 50
- •Male or female
- •Healthy subjects with no known condition that directly or indirectly affects the structure of the eye
- •Covered by health insurance
排除标准
- •For all subjects:
- •Inability to remain motionless on a standard ophthalmic chin rest. RETION_Protocol_v2.0 dated June 10, 2026_IDRCB: 2026-A00324-47 Page 10 of 44
- •Subjects taking medications or suffering from a medical condition that could interfere with the evaluations planned under the protocol;
- •Participants allergic to tropicamide in cases where pupil dilation is required. ☞ Wearing glasses or contact lenses to correct a refractive error is not considered an exclusion criterion.
结局指标
主要结局
Proportion of images obtained with the MONA system deemed usable for the analysis of retinal microstructures.
时间窗: 48 months
Images are considered usable if they allow for: * visualization of retinal microstructures (yes/no); * measurement of cell density (yes/no); * measurement of vascular diameter (yes/no).
次要结局
未报告次要终点
研究者
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