Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Evaluate subjects' ability to perform multiple OCT self-scanning following a self-tutorial on the Notal Vision Home OCT (NVHO)
研究概览
简要总结
Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT The purpose of this study is to collect data on the NVHO device at up to three sites.
详细描述
7 Study Procedures and Office Visit Schedule Informed Consent Voluntary informed consent will be obtained from every subject prior to the initiation of any screening or other study related procedures. The Investigator must have a defined process for obtaining informed consent. Specifically, the Investigator, or designee, will explain the clinical study to each potential patient and the patient must indicate voluntary consent by signing and dating of the approved informed consent form. The patient must be provided an opportunity to ask questions to the Investigator, and if required by local regulation, other qualified personnel.
Description of Study Procedures and Visits 7.2.1 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. 2. Following signing the ICF, subjects will be assigned a Subject ID by a designated staff at the clinical site. 3. 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 3. 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 or Spectralis 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
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to speak, read and understand English.
- •Ability to agree, understand and sign the informed consent form.
- •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
Evaluate subjects' ability to perform multiple OCT self-scanning following a self-tutorial on the Notal Vision Home OCT (NVHO)
时间窗: within 2 hours of an office visit
% of completion a self-imaging session
Scanning session completion status - complete/incomplete
时间窗: within 2 hours of an office visit
Evaluate the repeatability of the Notal OCT Analyzer (NOA) automatic fluid volume quantification in volume scan from self-scanning with the NVHO in the central 10 degrees of the macula of Diabetic Retinopathy (DR) patients
时间窗: within 2 hours of an office visit
NVHO volume scan Total Retinal Fluid (TRF) amount measured by NOA, NVHO volume scan Intra-Retinal Fluid (IRF) amount measured by NOA, NVHO volume scan Sub-Retinal Fluid (SRF) amount measured by NOA
Compare fluid quantification in images from NVHO and a commercial OCT
时间窗: within 2 hours of an office visit
Compare fluid quantification in images captured by the NVHO, as calculated by the Notal OCT Analyzer (NOA) algorithm and the fluid quantification in images captured by a commercial OCT, as marked by a human reader - in the central 10 degrees of the macula of DR patients Zeiss Cirrus or Spectralis OCT volume scan Total Retinal Fluid (TRF), Intra-Retinal Fluid (IRF), Sub-Retinal Fluid (SRF) amount measured by a human reader
次要结局
- Safety Endpoints(within 2 hours of an office visit)