跳至主要内容
临床试验/NCT03442816
NCT03442816撤回不适用

Evaluation of a Metabolic Hyperspectral Retinal Camera (MHRC) in Spectrally Resolved Reflectance and Fluorescence Imaging in a Diverse Population

Optina Diagnostics Inc.2 个研究点 分布在 1 个国家开始时间: 2017年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Quality images in reflectance and fluorescence

研究概览

简要总结

This research project aims to evaluate use in a clinical context of a novel imaging instrument, the Metabolic Hyperspectral retina Camera (MHRC) from Optina Diagnostics. This camera enables the acquisition of retinal images at multiple colors (up to 100 specific colors) and therefore extract way more information that can be captured with a conventional retinal camera (up to 3 colors). This additional color information available for each pixel of the image could be useful to identify signs of pathologies having manifestations in the retina. The performances of this new prototype camera will be evaluated and the acquisition procedures optimized in a diverse population of subjects.

详细描述

Hyperspectral retinal imaging results from several consecutive images taken while the filter scans a wide spectral range to obtain one spectrum for each image pixel. The combination of imaging and spectroscopy offered by hyperspectral imaging makes it possible to identify and quantify several specific biomolecules in the retina and the optic nerve, thus paving the way for metabolic imaging of the fundus. Subsequent analysis of the light signal with algorithms and image analysis software tools permits extracting molecular information modulated according to the underlying pathology. This technique thus permits direct, non-invasive and inexpensive diagnosis of pathologies of the retina and systemic pathologies presenting manifestations in the eye.

In this research project, Optina Diagnostics aims to evaluate in a clinical context a novel Metabolic Hyperspectral Retinal Camera (MHRC) based on a mydriatic camera customized for observation of the fundus in combination with a tunable filter, i.e., one permitting selection of a specific wavelength, in order to provide monochromatic light in the visible and near infrared spectrum (energy spectrum between 450 and 900 nm).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • 18 years old and up with vision in at least one eye.

排除标准

  • Inadequate pupil dilation (< 6mm diameter) or contraindicated
  • Deficient visual fixation
  • Refractive error outside the -9 to +9 range
  • Media opacities or intraocular bleeding preventing retinal imaging

结局指标

主要结局

Quality images in reflectance and fluorescence

时间窗: 1 day visit

Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population .

次要结局

未报告次要终点

研究者

发起方
Optina Diagnostics Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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