An observational study in Healthy, sponsored by Optina Diagnostics Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-25.
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.
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. 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.
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.
TABLE 5.1: US population demographics
Gender* 49.5% Male 50.5% Female
Age* 55% 18-64 years old 17% 45+ years old
Ocular Health in adults 40+ yrsǂ 44% Normal ocular health 56% Eye symptoms
* based on US census data (accessed on 30-April-2023) ǂ based on CDC Fast Facts about Vision Loss
Of note, these are only guidelines to aid with recruiting a study population that is representative of the adult population in the United States.
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 participant will undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.
At least one (1) Deep Learning (DL) model that characterizes the retina.
Time frame: 12 months
Review of any safety events (AE, SAE, UADEs) that occur throughout the study.
As an exploratory study, there are no acceptance criteria for these study outcomes, rather the study results will be summarized in a Final Clinical Study report that will document the study outcomes and any learnings/models that may be applied to new development project using the MHRC H5 images
Time frame: 12 months
Start is estimated for Nov 2023; primary completion for Jul 2024, 8 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Optina Diagnostics Inc.