RDP Reliability Study

NCT06057493 | Completed

• 1 other identifier: 23-008
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study designed to assess the reliability and consistency of the Optina awAIrTM CAS Test for detecting phenotypic changes in the retina that are associated with beta-amyloid status (positive or negative). The purpose of this study is to ensure that the retinal image capture process is consistent and under control, regardless of the operator or the time of measurement. The study will include enough repeated measurements on different systems, by three operators, and at different times to demonstrate.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The reliability of the investigational device's imaging process will be analyzed using agreement of CAS Test results within 95% confidence intervals for the following conditions:

  * Eye to eye variability * Eye selection process variability * Instrument to instrument variability * Inter-Operator variability * Intra-Operator variability

  12 months

Interventions

Retinal Imaging with Optina4C Camera OTHER

The study consists of 2 visits and 8 Imaging sessions: The participant will go through four (8) imaging sessions in two visits with the Optina-4CTM cameras to get pictures of your retina. These imaging sessions will be done by three qualified operators who have been trained on the study device by Optina Diagnostics.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men and women 50 years and older who can undergo pupil dilation for both eyes and are not contraindicated for mydriatic imaging with a fundus camera.

You may qualify if:

• Male and female adults aged 50 years and older with vision in both eyes.
• Sufficient fluency in English or French to participate in study visits.
• Ability to give informed consent.
• Individuals with both eyes meet the eligibility criteria for retinal imaging.

You may not qualify if:

• Pupil dilation contraindicated (due to 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 Optina 4CTM camera.
• Diagnosis of glaucoma or signs of glaucoma (excavation ratio ≥0.7).
• Signs of vascular occlusion or retinopathy (microaneurysm, exudate, hemorrhage, or edema) within a diameter of 10 mm from the mid-point between the optic nerve head and the macula.
• Presence of drusen and/or age-related macular degeneration (AREDS 9-step scale
• ≥4 - cumulative drusen area diameter ≥ 250 µm, pigmentary changes and cumulative drusen area diameter ≥ 63 µm or pigmentary changes and cumulative geographic atrophy area diameter ≥ 354 µm).
• Nuclear sclerosis \> 2 (LOCS II four-point grading system) or presence of central cortical or central posterior subcapsular cataract.
• Deficient visual fixation (inability to fixate for at least 2 s).
• Refractive error outside the range of -15 D to +15 D.
• Corneal or media opacities (e.g., Weiss ring) affecting retinal imaging on a cumulative area \> 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula (i.e., the area of interest for the Optina 4CTM imaging)
• Scar, atrophy, naevus, tumor, epiretinal membrane or retinal pucker with a cumulative area \> 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula.
• Papilledema and/or optic disc swelling.
• Macular anomaly (e.g., macular hole, dystrophy, degeneration).
• Currently taking or has previously taken cerebral amyloid modifying medication.

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead

Study Sites (1)

LMC Montreal Ville St Laurent

Montreal, Quebec, H4T 1Z9, Canada

Location

Study Officials

• Ramina Nissan, O.D

  LMC Montreal Ville

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: September 19, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)