Home OCT Repeatability and Reproducibility of Automatic Fluid Quantification Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Zeiss Cirrus OCT Intra-Retinal Fluid (IRF) amount measured by a human reader
研究概览
简要总结
The study will enroll up to 30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at 1 site in the United States. Subjects must meet all inclusion and no exclusion criteria.
详细描述
Description of Study Procedures and In-Office Visit:
Enrollment/Screening:
At the Enrollment/ Screening Visit, the exams will be conducted in the following order:
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Patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures.
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The following data will be collected for each study subject:
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Subject's DOB
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Gender
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Number and type of injections and last injection date
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The following data will be collected for the study eye:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to speak, read and understand English.
- •Ability to understand and agree to contents of informed consent in writing or verbal.
- •Adult diagnosed with NV-AMD in at least one eye based on the subject's medical record.
- •Fluid presence in the study eye per the PI review of Screening commercial OCT.
- •Best corrected Visual Acuity of 20/320 or better in the study eye.
- •Available and willing to conduct self-scanning in the office
排除标准
- •Any other retinal disease requiring steroidal or anti-VEGF injections.
- •Dilated pupils
结局指标
主要结局
Zeiss Cirrus OCT Intra-Retinal Fluid (IRF) amount measured by a human reader
时间窗: 5 minutes
volume \[nl\] of the IRF
Notal Home OCT Sub-Retinal Fluid (SRF) amount measured by NOA
时间窗: 5 minutes
volume \[nl\] of the SRF
Zeiss Cirrus OCT Sub-Retinal Fluid (SRF) amount measured by a human reader
时间窗: 5 minutes
volume \[nl\] of the SRF
Notal Home OCT Intra-Retinal Fluid (IRF) amount measured by NOA
时间窗: 5 minutes
volume \[nl\] of the IRF
Zeiss Cirrus OCT Total Retinal Fluid (TRF) amount measured by a human reader
时间窗: 5 minutes
volume \[nl\] of the TRF
Notal Home OCT Total Retinal Fluid (TRF) amount measured by NOA
时间窗: 5 minutes
volume \[nl\] of the TRF
次要结局
- Subjects who completed self-scanning on the Notal Home OCT, following a self-tutorial.(5 minuts)