Retinal Deep PhenotypingTM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

813 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. A sub-set of the images will also be analyzed by eye specialists to determine if visual inspection of the images could provide useful information in their practice.

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 2000 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.
* At least 5% of participants shall have an MHRC retinal image reviewed by an eye specialist (Optometrist or Ophthalmologist) to assess the image quality and potential clinical usefulness.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 and to determine the feasibility of visual inspection of the images for use in Optometry and/or Ophthalmology clinical practice. 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.

The MHRC retinal images will be transferred to a Picture Archiving and Communication System (PACS) for archiving and later evaluation. Additional information about the Study Participant will be captured in an Electronic Data Capture (EDC) system, including age, date of birth, gender, race/ethnicity, and color of their iris.

Images will be transferred to Optina for further digital analysis, including pre-processing (normalization, registration, and segmentation), feature extraction, and inclusion in Deep Learning models.

A subset (at least 5%) of the MHRC retinal scans will undergo visual inspection by an eye specialist (Ophthalmologist or Optometrist) to determine their quality and utility for inclusion in clinical practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Group Assignment

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ecole d'Optometrie, University of Montreal

Montreal, Quebec, Canada

Site Status

Clinique d'Opthalmologie desLaurentides, Institue de l'Oeil (IOL)

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-002

Identifier Type: -

Identifier Source: org_study_id