Status:
UNKNOWN
Automated AI-based System for Early Diagnosis of Diabetic Retinopathy
Lead Sponsor:
The New York Eye & Ear Infirmary
Collaborating Sponsors:
iHealthScreen Inc
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Brief 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...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05324189
Start Date
April 18 2022
End Date
December 1 2024
Last Update
April 12 2022
Active Locations (1)
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1
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States, 10003