Retinal Deep Phenotyping.TM

NCT05903664 | Withdrawn

• 1 other identifier: 22-002A
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• At least one (1) Deep Learning (DL) model that characterizes the retina.

  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

  12 months

Study Arms (1)

Single group assignment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead

Study Sites (1)

Wagner Macular & Retinal Center

Norfolk, Virginia, 23502, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: November 30, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

US (1)