Retinal Deep Phenotyping.TM

Optina Diagnostics

Status: Withdrawn

Conditions: Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT05903664

22-002A

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18 years and older who will undergo mydriasis (pupil dilation) as part of their eye clinic visit.

Exclusion criteria

• Contraindications for mydriatic fundus imaging.
• Pupil dilation contraindicated (due to a pathology, or presence of 3 quadrants with Van Herick grading of 0 or 1 without iridotomy).
• Inadequate pupil dilatation (< 6mm diameter) preventing uniform illumination of the retina with the MHRC.
• Refractive error outside the range of -15 D to +15 D.
• Deficient visual fixation (inability to fixate for at least 2 s)
• Inability of obtaining at least 3 images of satisfactory quality with the MHRC per the Optina Diagnostics quality index software and /or per the eye specialists' evaluation.

Trial design

0 participants in 1 patient group

Single group assignment

Description:

The participant will undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.