Telemedicine in Age-Related Macular Degeneration

NCT04863391 | Unknown FDA Device

• 1 other identifier: 18-00787
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Sensitivity of identification of referable and non-referable AMD for early diagnosis of AMD

  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 years

• 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.

  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).

  2 years

Study Arms (2)

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

intermediate/late AMD

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

Diagnostic Test: Referrable versus Non Referral AMD diagnostic test

Interventions

Referrable versus Non Referral AMD diagnostic test DIAGNOSTIC_TEST

Artificial intelligence read reports Referrable versus Non Referral AMD

early/none vs.; intermediate/late AMD

Eligibility Criteria

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

Study Population

Participants who fit the eligibility inclusion criteria and not the exclusion criteria.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead
• iHealthScreen Inc: collaborator

Study Sites (1)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Alauddin Bhuiyan, Ph.D.

CONTACT

718 926 9000; alauddin.bhuiyan@gmail.com

Katy Tai

CONTACT

2129794251; ktai@nyee.edu

Study Design

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

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 28, 2021
• Study Start: July 19, 2020
• Primary Completion: July 19, 2022
• Study Completion: December 31, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)