An observational study in Healthy, sponsored by Optina Diagnostics Inc.. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Optina Diagnostics Inc. · Observational
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:
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.
Optina Diagnostics Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults ages 18 years and older who have undergone pupil dilation and are not contraindicated for mydriatic imaging with a fundus camera. Ideally, the study population will be reflective of the adult population with the following estimates for demographics.
Gender* 49% Male 51% Female
Age* 45% 18-44 years old 55% 44+ years old
Ocular Health ǂ 70% Normal ocular health 30% Eye symptoms
* based on 2021 Canada census data ǂ based on CNIB Fast Facts about Vision Loss
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects will undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.
At least one (1) pre-trained DL model from hyperspectral retinal images.
Time frame: 12 months
Report describing the clinical utility of visual inspection of the MHRC retinal images.
Time frame: 12 months
Review of any safety events (AE, SAE, UADEs) that occur throughout the study.
Time frame: 12 months
Ran from Apr 2023 to primary completion in Mar 2024, 11 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Optina Diagnostics Inc.