Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT05903651
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2023-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retinal Deep PhenotypingTM
Sponsor:
Optina Diagnostics Inc.
Organization:
Study Overview
Official Title:
Retinal Deep PhenotypingTM by a Novel Mydriatic Hyperspectral Retinal Camera (MHRC) and Analysis by Deep Learning
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: