RECRUITING

Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in the primary care and endocrinology 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 symptoms 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.

Official Title

Pivotal Trial of Automated AI-based System for Early Diagnosis of Diabetic Retinopathy Using Retinal Color Imaging

Quick Facts

Study Start:2025-01-01
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07151001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age of Subjects: Patients ≥ 22 years of age.
  2. * Gender of Subjects: Both males and females will be invited to participate.
  3. * Subjects with diabetes (A1C level ≥ 6.5).
  4. * Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent.
  1. * Unable to understand the study, Our unable to or unwilling to sign the informed consent
  2. * Previously diagnosed with macular edema, any form of diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
  3. * participants who are experiencing persistent vision loss, blurred vision, or other vision problems that should be evaluated by an eye care provider
  4. * subjects whose retinal images were used in training, validating, or developing the device
  5. * Currently participating in another investigational eye study or actively receiving investigational product for DR or DME.
  6. * A condition that, in the opinion of the investigator, would preclude participation in the study;
  7. * Contraindicated for imaging by fundus imaging systems used in the study because of hypersensitivity to light, recently underwent photodynamic therapy, or was taking medication that causes photosensitivity.

Contacts and Locations

Study Contact

Alauddin Bhuiyan
CONTACT
718-926-9000
bhuiyan@ihealthscreen.org
Fariha Nuha, BS (Comp. Biology)
CONTACT
718-912-0837
fariha@ihealthscreen.org

Principal Investigator

Alauddin Bhuiyan, PhD
PRINCIPAL_INVESTIGATOR
iHealthScreen Inc

Study Locations (Sites)

iHealthScreen Inc.
Richmond Hill, New York, 11418
United States

Collaborators and Investigators

Sponsor: iHealthScreen Inc

  • Alauddin Bhuiyan, PhD, PRINCIPAL_INVESTIGATOR, iHealthScreen Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • Early Diagnosis
  • Screening

Additional Relevant MeSH Terms

  • Diabetes
  • Diabetic Retinopathy