Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03442816 |
| Other study ID # |
050317 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2017 |
| Est. completion date |
September 26, 2020 |
Study information
| Verified date |
September 2019 |
| Source |
Optina Diagnostics Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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).
