Telemedicine in Age-Related Macular Degeneration

• Sponsor: The New York Eye & Ear Infirmary (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04863391
• Collaborator: iHealthScreen Inc (Industry)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 29.4
• Patients Per Site Per Month: 34

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Diagnostic Test: Referrable versus Non Referral AMD diagnostic test

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age Related Macular Degeneration in Primary Care Settings.
• Actual Study Start Date: Jul 19, 2020
• Anticipated Primary Completion Date: Jul 19, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
early/none vs. For identification of early/none (i.e., non-referral level) Age Related Macular Degeneration (ARMD)	Diagnostic Test: Referrable versus Non Referral AMD 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)	Diagnostic Test: Referrable versus Non Referral AMD diagnostic test; Artificial intelligence read reports Referrable versus Non Referral AMD

Outcome Measures

Primary Outcome Measures

1. Sensitivity of identification of referable and non-referable AMD for early diagnosis of AMD [2 years]

   Sensitivity of identification of referable and non-referable AMD for early diagnosis of AMD using the iPredict's AI-based AMD screening software utilizing color fundus imaging.

2. Specificity of identification of referable and non-referable AMD for early diagnosis of AMD using the iPredict's AI-based AMD screening software utilizing color fundus imaging. [2 years]

   Using the gold standard (i.e., the ophthalmologist's grading), the sensitivity and specificity are calculated as: Sens=TP/(TP+FN) Spec=TN/(TN+FP) Where TP is the number of true positives (referable AMD subjects correctly classified), FN is the number of false negatives (referable AMD subjects incorrectly classified as non-referable), TN is the number of true negatives (non-referable subjects correctly classified), and FP is the number of false positives (non-referable AMD subjects incorrectly classified as referable AMD).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Eye and Ear Infirmary of Mount Sinai	New York	New York	United States	10003

Sponsors and Collaborators

• The New York Eye & Ear Infirmary
• iHealthScreen Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The New York Eye & Ear Infirmary
• ClinicalTrials.gov Identifier: NCT04863391
• Other Study ID Numbers: 18-00787
• First Posted: Apr 28, 2021
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Apr 28, 2021