Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Image quality excellence rate
研究概览
简要总结
This prospective, multicenter, single-group, target-value clinical trial was designed to evaluate the efficacy and safety of an Adaptive Optics ScanningLaser Ophthalmoscope(AOSLO) for ophthalmic examination.
详细描述
objective: This study aims to collect AOSLO retinal images from human population to assess the imaging quality and quantitative measurement consistency of AOSLO devices manufactured by Robotrak and also monitor any possible side effects.
study population: randomly invited 194 volunteers who meets inclusion criteria
design: the study is an observational protocol that participants will be imaged with Robotrak AOSLO systems to get cellular level images of photoreceptors and blood vessels in foveal area. Automatics analysis of cell/blood vessel morphology parameters will be calculated for consistency evaluation. In general, participants will undergo a complete ophthalmic examination including assessments of visual acuity, intraocular pressure, slit lamp examination, ocular biometry, OCT, fundus imaging, multi-focal ERG and OCT scan to assess potential side effects of AOSLO imaging.
outcome measures: the primary efficacy outcome measure of this study are multi expert grading of the image quality collected.
the secondary efficacy outcome measure are quantitative assessment of the morphological parameters generated from the captured images and device operator ratings.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Image quality excellence rate
时间窗: through study completion, an average of half year
Divide the collected images into 25 small squares based on a 5X5 square grid; Divide each small square into "clear" and "under clear" based on whether the mosaic structure of photosensitive cells is clear and visible. Divide the entire 2.4 ° X2.4 'image into three levels: "excellent", "good", and "poor" based on the proportion of small squares evaluated as "clear" among the 25 squares in each image: "excellent" is defined as the proportion of "clear" small squares ≥ 80%; The definition of "good" image quality is that the proportion of "clear" small squares is\>60% but\<80%; The definition of "poor" image quality is that the proportion of "clear" small squares is less than 60%; Calculate the proportion of images with "excellent" and "good" imaging quality to all images.
次要结局
- Satisfaction rate of clinical function and applicability evaluation of devices(through study completion, an average of half year)
- Repeatability of cell analysis function(through study completion, an average of half year)
- Repeatability of vascular blood flow analysis function(through study completion, an average of half year)
- Satisfaction rate of device performance and operational evaluation(through study completion, an average of half year)
- Adverse event occurrence rate(through study completion, an average of half year)