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临床试验/NCT05202587
NCT05202587已完成不适用

The Evaluation of the Agreement and Precision of the Notal Vision Home OCT in the Automatic Fluid Quantification in Patients With NV-AMD.

Notal Vision Inc.5 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
386
试验地点
5
主要终点
Sub-Retinal Fluid (SRF)

研究概览

简要总结

This multi-center study will enroll Adult subjects diagnosed with neo-vascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment. the subject study duration for this study is one day (2-3 hours). Each study site will have two NVHO devices and one Cirrus 5000 and the patients will be scand on the two NVHO devices and one Cirrus device as a part of the study flow. At the Study Visit, fluid must be present in approximately 280 study eyes and fluid must be absent from 20 study eyes. Each subject will only have one study eye. The fluid status will be determined by the investigator while reviewing an acceptable screening Cirrus OCT volume scan.

详细描述

Screening will include refraction, best corrected visual acuity and Cirrus OCT. Subjects will receive a general overview of the self-operation of the NVHO system. The general overview will include written material and a verbal explanation.

If only one eye qualifies for enrollment, that eye will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule unless the fluid type (IRF or SRF) between eyes is different, in which case the randomization can be overridden at the discretion of an Investigator to fulfill the required sample size of the fluid type. volume scans will be calculated for each enrolled eligible study eye Once the study eye has been identified, the subject will be assigned to either perform a Cirrus OCT first or perform self-imaging on a NVHO first. The order between the Cirrus OCT or the NVHO will be assigned according to a randomization schedule. Whichever is assigned first will be completed followed by the second assigned device.

Cirrus OCT Scans:

When the study eye is assigned to perform the Cirrus OCT, the study eye will be scanned, non-dilated with a Cirrus 5000 OCT device, up to 4 times with the objective of obtaining two acceptable volume scans for the study eye. The enrolled subjects that are randomized to have Cirrus volume scans first will be discontinued before NVHO self-imaging if two acceptable Cirrus volume scans cannot be obtained.

NVHO Scans:

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

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.
  • Adult diagnosed with NV-AMD in at least one eye with or without fluid based on the subject's medical record.
  • Best corrected Visual Acuity of 20/320 or better in the study eye.
  • Available and willing to conduct Cirrus imaging and NVHO self-imaging in a clinic environment.
  • Note: Eyes with other pathologies including pseudocysts, outer retinal tubulations, pigment epithelial detachments, hemorrhage, subretinal hyper-reflective material (SHRM), geographic atrophy, sub-retinal pigment epithelium (RPE) hypo-reflective areas, epiretinal membrane (ERM), macular hole, and hyperreflective retinal spots (Foci) can be enrolled.

排除标准

  • Any other retinal disease requiring steroid or anti-VEGF injections.
  • Cirrus scan during screening with Signal Strength <
  • Dry AMD in study eye.

结局指标

主要结局

Sub-Retinal Fluid (SRF)

时间窗: 5 minutes

volume \[nl\] of the Sub-retinal fluid

Intra-Retinal Fluid (IRF)

时间窗: 5 minutes

volume \[nl\] of the Intra-retinal fluid

IRF spatial distribution

时间窗: 5 minutes

frontal view (en-face) of IRF thickness map

SRF spatial distribution

时间窗: 5 minutes

frontal view (en-face) of SRF thickness map

IRF area segmentation

时间窗: 5 minutes

Segmented B-scans of the IRF

SRF area segmentation

时间窗: 5 minutes

Segmented B-scans of the ISRF

Mean central retinal thickness

时间窗: 5 minutes

Retina thickness (µ) in 5 central ETDRS grid fields (Total, superior, temporal, inferior, nasal, and central)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (5)

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