NOT_YET_RECRUITING
Automated AI-based System for Early Diagnosis of Diabetic Retinopathy
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.
Conditions:
🦠 Diabetic Retinopathy
🗓️ Study Start (Actual) 18 April 2022
🗓️ Primary Completion (Estimated) 1 December 2023
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age of Subjects: Patients ≥ 18 years of age.
    • * Gender of Subjects: Both males and females will be invited to participate.
    • * Subjects with diabetes (A1C level 6.5 or higher) or Fasting Plasma Glucose (blood sugar level) 126 mg/dL (≥7.0 mmol/L)
    • * Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent.
    • * asymptomatic patients with DR.

    Exclusion Criteria:

    • * Subject has retinal degenerations and retinal vascular diseases such as age-related macular degeneration or having undergone prior retinal surgery.
    • * History of ocular injections,
    • * Subject has persistent visual impairment in any eye;
    • * History of macular edema or retinal vascular (vein or artery) occlusion;
    • * laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
    • * Subject is currently enrolled in an interventional study of an investigational device or drug;
    • * Subject has ungradable clinical reference standard photographs (i.e., not gradable quality image). If the patient image is not gradable automatically, we will suggest the patient to refer the ophthalmologist.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 8 November 2021
  • First Submitted that Met QC Criteria 5 April 2022
  • First Posted 12 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 April 2022
  • Last Update Posted 12 April 2022
  • Last Verified November 2021