Automated AI-based System for Early Diagnosis of Diabetic Retinopathy

Status Not yet recruiting

Clinical Trial Summary

In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR)in the primary care, optometrist and other diabetes-screening clinics. DR is one of the leading causes of blindness in the United States and other developed countries. Every individual with diabetes is at risk of DR. It does not show any symptom until the disease is progressed to advanced stages. If the disease is caught at an early stage, it can be prevented, managed or treated effectively. Currently, screening for DR is done by the Ophthalmologists, which is limited to areas with limited availability. This is also time-consuming and expensive. All of these can be complemented by automated screening and set up the screening in the primary care clinics.

Clinical Trial Description

In this pivotal trial, we aim to invite diabetic patients to participate in the trial by having non-dilated photos of their eyes taken by an FDA-approved DRS plus camera at their own doctor's office which will test the feasibility of our proposed automated AI based DR diagnosis software solution,. The color fundus photos will be captured and then be transmitted securely and analyzed by iHealthScreen's HIPAA compliant server at Amazon cloud. The deep learning module will analyze the image for finding the disease severity. The automated report will be generated which will report as referable DR or more than mild (mtm) DR detected i.e., moderate DR, severe DR - proliferative or non-proliferative DR or Non-referable DR or mtm DR not detected, i.e., mild DR or no DR. The same images will be evaluated by 3 ophthalmologists and will be adjudicated if any disagreement between the gradings. The automatic and expert evaluation will be compared to compute the sensitivity, specificity and AUC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05324189
Study type	Observational
Source	The New York Eye & Ear Infirmary
Contact	R. Theodore Smith, MD, PHD
Phone	646-943-7925
Email	rolandtheodore.smith@mssm.edu
Status	Not yet recruiting
Phase
Start date	April 18, 2022
Completion date	December 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.