Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- NVHO Total Retinal Fluid (TRF)
研究概览
简要总结
In this clinical study the Notal Vision Home OCT (NVHO) Monitoring System will be used to evaluate the ability of patients diagnosed with DME to perform sequential self-images of their eyes with the self-operated NVHO device in a home simulated environment in the doctor's office.
The study population will include up to 30 patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one site in Israel.
详细描述
Office Visit NOTE: Any planned treatment for DME at the day of the study should be administered after completion of all study-related scans
At the enrollment Office 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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Following signing the ICF, subjects will be assigned a Subject ID by a designated staff at the clinical site.
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The following data will be collected for each study subject:
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Date of birth
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Gender
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Number and type of Anti-VEGF injections and last injection date
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Refraction correction 4. Snellen BCVA on both eyes on the day of the visit. 5. Eligible eye(s) of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device with one (1) acceptable volume scan of each eye being obtained out of up to 3 attempts.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to speak, read and understand Hebrew.
- •Ability to understand and agree to contents of informed consent.
- •Eighteen (18) years of age or older at the time of Informed Consent.
- •Subjects diagnosed with DR (Diabetic Retinopathy) in at least one eye, with or without DME
- •Best corrected Visual Acuity of 20/320 (6/96) or better in eyes participating at the study.
排除标准
- •Subjects with dilated pupils.
- •Subjects with other retinal disease requiring steroidal or anti-VEGF injections.
结局指标
主要结局
NVHO Total Retinal Fluid (TRF)
时间窗: 5 minutes
volume (nl) measured by NOA (automatic OCT analyzer)
Zeiss Cirrus OCT Intra-Retinal Fluid (IRF)
时间窗: 10 minutes
volume (nl) measured by a human reader
NVHO Sub-Retinal Fluid (SRF)
时间窗: 5 minutes
volume (nl) measured by NOA (automatic OCT analyzer)
NVHO Intra-Retinal Fluid (IRF)
时间窗: 5 minutes
volume (nl) measured by NOA (automatic OCT analyzer)
Zeiss Cirrus OCT Total Retinal Fluid (TRF)
时间窗: 10 minutes
volume (nl) measured by a human reader
Scanning session completion status
时间窗: 5 minutes
complete/incomplete
Zeiss Cirrus OCT Sub-Retinal Fluid (SRF)
时间窗: 10 minutes
volume (nl) measured by a human reader
次要结局
未报告次要终点