Home OCT Fluid Visualization Agreement Study at Multiple Retinal Clinics With Placement of One Home OCT Device in the Home of Each NV-AMD Subject in the US for 5 Weeks
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Positive percent agreement
研究概览
简要总结
This is a single arm study of home monitoring with the NVHO for 5 weeks with office visits at enrollment, Week 1 and Week 5 (Exit Visit) and, when applicable, Interim Visit(s) triggered by ongoing review by the Reading Center. The study will enroll subjects diagnosed with NV-AMD in at least one eye with attention to the proportion of eyes with IRF and/or SRF. The enrolled eligible subjects will be instructed to self-image the study eye(s) once daily for 5 weeks using a NVHO device at home with scheduled in-office examinations at Week 1, Week 5 and Interim Visits, when applicable, with additional in-office Cirrus volume scans acquired at these office visits. The self-imaging data on the NVHO will be automatically uploaded to the Notal Health Cloud and from there the reconstructed volume scans will sent to the study database.
详细描述
The objectives of this study are to (1) evaluate the agreement, via positive percent agreement (PPA) and negative percent agreement (NPA), between OCT images captured by the NVHO and by the Zeiss Cirrus HD-OCT in the visualization of fluid as identified by a RC, in the central 10 degrees of the macula of NV-AMD patients, and (2) evaluate the ability of subjects diagnosed with NV-AMD to set up the device and self-image their eyes at home with the NVHO device (rate of successful imaging attempts).Description of Study Visits and Procedures:
Enrollment Visit:
At this visit, the exams will be conducted in the following order:
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Subject will be informed concerning the study and sign the Informed Consent Form (ICF) prior to the 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 date of birth (DOB) (if allowed) or age
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Gender
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Race
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Ethnicity
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Level of education
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Eye exams, including Snellen BCVA and subjective symptoms (visual distortions, blurry vision, and scotoma), will be performed on both eyes on the day of the visit.
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Both eyes of the subject will be imaged using a commercial Zeiss Cirrus OCT using the 6mm X 6mm, 512 X 128 volume scan program, with a maximum of three attempts for each eye to reach an acceptable image quality per the Cirrus User's Guide and reviewed by the PI to determine fluid status.
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One or both eye(s) of the subject that meets all screening criteria, including having a diagnosis of NV-AMD in at least one eye previously or at the enrolment visit, will be enrolled in the study.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have the ability to speak, read and understand English.
- •Ability to understand and agree to contents of informed consent either in writing or verbally.
- •Age 55 or older at the Enrollment Visit.
- •Adults diagnosed with NV-AMD in at least one eye based on the subject's medical record. Fellow eyes diagnosed with dry AMD may be included as secondary eyes to a primary eye diagnosed with NV-AMD.
- •Note: eyes whit other pathologies including pseudocysts, outer retinal tabulations, pigments epithelial, detachments, hemorrhage, sub retinal hyper reflective material (SHRM), geographic atrophy and sub RPE, hypo reflective areas can be enrolled.
- •Best corrected Visual Acuity of 20/320 or better in eyes that will perform self-imaging.
- •Available and willing to set up a device and conduct self-imaging at their home.
排除标准
- •Anti-VEGF treatment for NV-AMD in the study eye(s) at the screening visit.
- •Any other retinal disease requiring steroidal or anti-VEGF injections.
- •Prior experience with the NVHO device.
结局指标
主要结局
Positive percent agreement
时间窗: 1 month following reading center grading completion
Positive percent agreement (PPA) of fluid status when comparing the fluid status in the central 3mm X 3mm of the NVHO volume scan graded by an independent reading center to the fluid status in the central 3mm X 3mm of Cirrus volume scan graded by an independent reading center.
Negative percent agreement
时间窗: 1 month following reading center grading completion
Negative percent agreement (NPA) of fluid status when comparing the fluid status in the central 3mm X 3mm of the NVHO volume scan graded by an independent reading center to the fluid status in the central 3mm X 3mm Cirrus volume scan graded by an independent reading center.
Percentage of subjects who successfully completed the setup of the NVHO device
时间窗: 5-10 minutes
Percentage of subjects who successfully completed the setup of the NVHO, indicated by the initiation of the tutorial.
Percentage of subjects who Successful completed NVHO self-imaging
时间窗: 2-3 minutes
Percentage of subjects who Successful completed NVHO self-imaging, namely a volume macular scan has been captured.
次要结局
- Percentage of all sessions that were transmission successfully(10-15 minutes)
- Percentage of sessions containing self-imaging that were transmitted successfully(10-15 minutes)