NCT04863391

Telemedicine in Age-Related Macular Degeneration

Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age Related Macular Degeneration in Primary Care Settings.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: The New York Eye & Ear Infirmary · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This study seeks to evaluate a system for the automated early detection of Age-Related Macular Degeneration (AMD). AMD is a condition in which there is breakdown of the macula of the eye, the part of the retina that is responsible for sharp, central vision. We will take pictures of subjects' eyes using an automated camera. These photographs will be securely transmitted and and then analyzed by a computer program which has been developed in other studies. The outcome of the computer program analysis will be compared with human analysis of these same pictures. If the computer analysis is has good enough accuracy, then this computer system could be used for wide-scale screening for AMD.

Detailed description

iPredict,an AI and telemedicine based software which used individual's color fundus image for early diagnosis of AMD and predict if an individual is at risk of progression to late AMD. iPredict platform integrates the server-side programs (the image analysis and deep-learning modules for AMD severity screening and prediction) and local remote computer/mobile devices (for collecting patient data and images). DRS plus camera will be used in the doctor's office. The remote devices will upload images and data to the server to analyze and screen AMD automatically. The telemedicine platform has been developed for web-based platform. The automatic analysis will be performed on the server, and a report will be sent to the patient/remote devices with an individual's AMD stage as referable or non-referable AMD, and a risk prediction score of developing late AMD (within a minute), and further recommendations to visit a nearby ophthalmologist.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Referrable versus Non Referral AMD diagnostic test	Artificial intelligence read reports Referrable versus Non Referral AMD

Timeline

• Start date: 2020-07-19
• Primary completion: 2022-07-19
• Completion: 2022-12-31
• First posted: 2021-04-28
• Last updated: 2021-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study