Evaluation of Repeated, In-Clinic, Self-Imaging by NV-AMD 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
- 70
- 试验地点
- 1
- 主要终点
- Summary of subject questionnaire results.
研究概览
简要总结
this is a single In-Clinic Encounter With the Notal Vision Home OCT study. The study population will include up to 50 Age-related Macular Degeneration patients diagnosed with wet NV-AMD in at least one eye at the time of enrollment. All enrolled subjects should have at least one eye with active (wet) CNV (SRF and/or IRF) at the time of enrollment. All subjects will be enrolled at 1 site in the United States. in this study patients will be placed in a room with the Notal Vision Home OCT device and following a completion of a self tutorial will perform 3 unsupervised self-scans on each study eye (with a rest of ~5 minutes between self-scans). at the end of the testing sessions, the subject will be asked to complete subject user questionnaire.
详细描述
Office Visit:
At the enrollment Office Visit, the exams will be conducted in the following order:
-
Patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures
-
The following data will be collected for each study subject:
-
Subject's DOB (if allowed) or age
-
Gender
-
Number and type of injections and last injection date
-
Refraction correction
-
Snellen BCVA on both eyes on the day of the visit.
-
Eligible eyes of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device 3 times with one (1) acceptable volume scan of each eye being obtained.
Scanning pattern to be used:
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 either in writing or verbally.
- •Eighteen (18) years of age or older at the time of Informed Consent.
- •AMD patients diagnosed with wet NV-AMD in at least one eye (ie, with SRF, and/or IRF).
- •Fellow eye with NV-AMD (with or without fluid) or intermediate AMD.
- •Best corrected Visual Acuity of 20/320 or better in eyes participating at the study.
排除标准
- •Subjects with dilated pupils.
- •Any other retinal disease requiring steroidal or anti-VEGF injections.
结局指标
主要结局
Summary of subject questionnaire results.
时间窗: 5-10 minutes
For the multi-choice questions - the average score (1-5) for each question. For open questions - collect the user's feedback for future improvements of the device
Percentage of eyes that performed 4 self-scans with the same fluid status
时间窗: About 30 min - upon completion of the study visit
Percentage of eyes that performed 4 self-scans, where their fluid status (fluid present/absent) is identical based both human reader and the Notal OCT Analyzer (NOA) artificial-intelligence (AI) module.
Agreement between the Cirrus OCT and the NVHO device in detecting fluid in the central 3x3mm of the macula.
时间窗: About 30 min - upon completion of the study visit
Percentage of subjects who completed self-scanning following a self-tutorial.
时间窗: 5-10 minutes
Percentage of subjects who were able to perform a full self-scanning and generate a retinal volume scan.
次要结局
未报告次要终点