COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Compare FAF retinal patterns by Clarus and Optos FAF imaging
研究概览
简要总结
The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).
Participants will:
- undergo pupillary dilation
- have photographs taken of the inside of the eyes using three different cameras
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 18 years and older with a clinical and/ or genetic diagnosis of IRD recruited either from the clinic and/or the Inherited Ocular Disease Registry to participate in this trial
- •Participants that are willing to participate as evidenced by signing the written informed consent
排除标准
- •Presence of ocular conditions other than an IRD which may affect the quality of ocular imaging including but not limited to advanced cataracts, corneal disorders, nystagmus, vitreous hemorrhage, or poor dilation
- •Presence of ocular conditions other than an IRD which may affect interpretation of retinal imagining including but not limited to epiretinal membrane, choroidal neovascular membrane, or macular scarring
- •Patients with advanced IRDs who are unable to fixate for imaging
- •Patients unable to tolerate ocular imaging
- •Patients who do not wish to participate
研究组 & 干预措施
Fundus autofluorescence (FAF) imaging
干预措施: Spectralis FAF imaging (Device)
Fundus autofluorescence (FAF) imaging
干预措施: Optos imaging (Device)
Fundus autofluorescence (FAF) imaging
干预措施: Clarus imaging (Device)
结局指标
主要结局
Compare FAF retinal patterns by Clarus and Optos FAF imaging
时间窗: Up to 2 hours
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging
时间窗: Up to 2 hours
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Compare Spectralis FAF imaging to Spectralis OCT imaging
时间窗: Up to 2 hours
In participants with clearly defined macular FAF retinal pattern changes, graders will independently measure area of retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging
时间窗: Up to 2 hours
Graders will independently measure area of FAF retinal patterns from images of each device. The measurements (in mm²) will be compared between the two devices.
次要结局
- Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images(Up to 2 hours)
- Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging(Up to 2 hours)