Telemedicine in Age-Related Macular Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-19

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Age Related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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early/none vs.

For identification of early/none (i.e., non-referral level) Age Related Macular Degeneration (ARMD)

Referrable versus Non Referral AMD diagnostic test

Intervention Type DIAGNOSTIC_TEST

Artificial intelligence read reports Referrable versus Non Referral AMD

intermediate/late AMD

intermediate/late (i.e., referral level) Age Related Macular Degeneration (ARMD)

Referrable versus Non Referral AMD diagnostic test

Intervention Type DIAGNOSTIC_TEST

Artificial intelligence read reports Referrable versus Non Referral AMD

Interventions

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Referrable versus Non Referral AMD diagnostic test

Artificial intelligence read reports Referrable versus Non Referral AMD

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent
2. Gender of Subjects: Both males and females will be invited to participate.
3. Age of Subjects: Patients will be over 50 years and older

Exclusion Criteria

1. Unable to provide informed consent.
2. Other retinal degenerations and retinal vascular diseases such as diabetic retinopathy or macular edema, prior retinal surgery.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes