NCT05903664

Retinal Deep Phenotyping.TM

Retinal Deep PhenotypingTM by A Novel Mydriatic Hyperspectral Retinal Camera (MHRC) And Analysis by Deep Learning

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Optina Diagnostics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications. As an exploratory study, there are no endpoints per se, however, the following sub-objective will be evaluated for determining the success of this study: * Collection and characterization of MHRC retinal images from at least 250 participants that score at least 80 on the real-time Quality Index (included in the MHRC software). * Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting.

Detailed description

This is an exploratory, observational, cross-sectional, multi-site study designed to collect a baseline dataset of MHRC retinal image scans for use in Deep Learning models. Subjects will be recruited from eye clinics where patients will undergo mydriasis (pupil dilation) as part of their clinical visit. Eligible participants will be provided information about the study and delegated site personnel will assist with the Informed Consent process. If a participant provides their Informed Consent, they will be enrolled in the study and undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.

Conditions

• Healthy

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-06-15
• Last updated: 2024-01-25

Locations

1 site across 1 country: United States