Retinal Metabolic Imaging in a Diverse Population

Study Overview
=================
Brief 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.

Detailed 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).

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

Conditions
-----------------
Technical Capabilities of the Device

Intervention / Treatment
-----------------
* Device: MHRC Camera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and up with vision in at least one eye. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will undergo 1) an ophthalmic evaluation and 2) an evaluation with the device (camera)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MHRC camera<br>Subjects will undergo a retina imaging session with the MHRC camera. | Device: MHRC Camera<br>* Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality images in reflectance and fluorescence | Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population . | 1 day visit |