Recruiting

Observational Study

Sponsor:

The New York Eye & Ear Infirmary

Code:

NCT04863391

Conditions

Age Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Referrable versus Non Referral AMD diagnostic test

Study Details

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

Study ID

NCT04863391

Start date

Jul 19, 2020

Status verified date

Apr, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Jul 19, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

early/none vs.

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

intermediate/late AMD

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

Interventions

Referrable versus Non Referral AMD diagnostic test

Artificial intelligence read reports Referrable versus Non Referral AMD

Primary outcome measure

  • Sensitivity of identification of referable and non-referable AMD for early diagnosis of AMD [ Time Frame: 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. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Alauddin Bhuiyan, Ph.D.

718 926 9000alauddin.bhuiyan@gmail.com

Katy Tai

2129794251ktai@nyee.edu

Locations

New York Eye and Ear Infirmary of Mount Sinai

Recruiting

New York, New York, United States, 10003

Contacts

Katy Tai

212-979-4251ktai@nyee.edu

Principal Investigator:

R. Theodore Smith, MD, PHD

More Information

Sponsor

The New York Eye & Ear Infirmary

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The New York Eye & Ear Infirmary on 2021-04-28.