NCT06860555

Hyperspectral Drusen Classification

Exploration of the Retinal Deep PhenotypingTM (RDP) Platform for the Identification of Spatial-spectral Features in Different Types of Drusenoid Deposits in Dry Age-related Macular Degeneration (AMD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: Optina Diagnostics Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This observational, cross-sectional study is designed to explore the feasibility to extract spatial-spectral features from hyperspectral retinal images captured with Optina Diagnostics' MHRC that are characteristic to the different types of drusenoid deposits associated with dry age-related macular degeneration.

Detailed description

In this observational, cross-sectional, prospective study, participants with dry AMD in at least one eye will undergo a hyperspectral retinal imaging session with the Optina Diagnostics' MHRC in addition to retinal imaging with OCT, used as the gold standard method to identify and classify the drusenoid deposits. Eligible participants visiting the eye clinic for AMD with dry AMD in at least one eye will be invited to participate in the study. Subjects who sign an informed consent to participate in the study will have their eyes evaluated to confirm that at least one eye is meeting all of the inclusion criteria, and none of the exclusion criteria. The dry AMD status and stage as well as information about eye diseases and conditions will be documented for both eyes. If eligible (no ocular exclusion criteria present in at least one eye), subjects will undergo OCT imaging of the macular region. If the OCT imaging session is successful (as described in the OCT imaging procedure below), the participants will then undergo hyperspectral retinal imaging with the Optina Diagnostics MHRC.

Conditions

• Dry Age Related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)	Imaging with the MHRC and optical coherence tomography (OCT).

Timeline

• Start date: 2022-11-08
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study