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Trial record 1 of 1 for:    BHUIYAN, ALAUDDIN
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Telemedicine in Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT04863391
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
iHealthScreen Inc
Information provided by (Responsible Party):
The New York Eye & Ear Infirmary

Study Description
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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
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
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Study Type : Observational
Estimated 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 : July 19, 2020
Estimated Primary Completion Date : July 19, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Sensitivity of identification of referable and non-referable AMD for early diagnosis of AMD [ Time Frame: 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. [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who fit the eligibility inclusion criteria and not the exclusion criteria.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863391


Contacts
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Contact: Alauddin Bhuiyan, Ph.D. 718 926 9000 alauddin.bhuiyan@gmail.com
Contact: Katy Tai 2129794251 ktai@nyee.edu

Locations
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United States, New York
New York Eye and Ear Infirmary of Mount Sinai Recruiting
New York, New York, United States, 10003
Contact: Katy Tai    212-979-4251    ktai@nyee.edu   
Principal Investigator: R. Theodore Smith, MD, PHD         
Sponsors and Collaborators
The New York Eye & Ear Infirmary
iHealthScreen Inc
More Information
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Responsible Party: The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT04863391    
Other Study ID Numbers: 18-00787
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no IPD sharing plan at this time.

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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:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases