COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Comparison of geographic atrophy area measurements by Optos with standard Spectralis imaging
研究概览
简要总结
The goal of this clinical trial is to compare measurements of geographic atrophy (GA) area between several types of imaging, in order to assess accuracy. The main question to answer is which imaging device provides measurements that are most similar to the standard of care device.
Participants will be patients of a retina doctor at University Station Eye Clinic with geographic atrophy, and can expect to be in the study for 60-75 minutes.
详细描述
This study is a single site pilot comparative imaging study in which enrolled participants will undergo dilated fundus exam as per standard of care. Study images will be obtained using Optos ultrawide field fundus autofluorescence (FAF) and both blue and green ultrawide field FAF with Zeiss Clarus. Autofluorescence (AF) imaging will also be performed on the Spectralis as it is currently the gold standard. The goal will be to obtain all images in 60-75 minutes over one visit. Images will be assessed, and area of geographic atrophy measured independently by two experienced readers.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years or older and may be either male or female and may be of any race
- •Established diagnosis of GA due to AMD
- •GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude subjects from participation
- •Willing to participate as evidenced by signing the written informed consent
排除标准
- •Unable to tolerate opthalmic imaging
- •Presence of neovascular AMD on OCT as confirmed by an ophthalmologist
- •Presence of significant media opacity preventing adequate retinal imaging
- •Presence of concurrent retinal disease which may confound assessment
研究组 & 干预措施
Fundus autofluorescence (FAF) imaging
干预措施: Optos imaging (Device)
Fundus autofluorescence (FAF) imaging
干预措施: Spectralis FAF imaging (Device)
Fundus autofluorescence (FAF) imaging
干预措施: Zeiss Clarus 700 imaging (Device)
结局指标
主要结局
Comparison of geographic atrophy area measurements by Optos with standard Spectralis imaging
时间窗: Up to 75 minutes
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Comparison of geographic atrophy area measurements between Clarus and Optos
时间窗: Up to 75 minutes
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Comparison of geographic atrophy area measurements by Clarus with standard Spectralis imaging
时间窗: Up to 75 minutes
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the two devices.
Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California
时间窗: Up to 75 minutes
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (Full Range Reported)
时间窗: Up to 75 minutes
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder
时间窗: up to 75 mintues
次要结局
- Prevalence of atrophy outside the standard 30 degrees in Clarus and Optos ultrawide field images(Up to 75 minutes)
- Prevalence of other autofluorescence abnormalities outside the standard 30 degrees in Clarus and Optos ultrawide field images(Up to 75 minutes)
- Prevalence of Atrophy Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images(Up to 75 minutes)
- Prevalence of Other Autofluorescence Abnormalities Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images(Up to 75 minutes)