Assessment of AI Program 'DRISTi' as a Screening Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-23

Study Completion Date

2026-03-31

Brief Summary

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A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion/exclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.

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Detailed Description

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Conditions

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Diabetic Retinopathy (DR)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Fundus Image Grading

The image is graded by a fully automated AI device

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Ability to sign and date the informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age (≥)21 years of age or older
4. Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)

1. Hemoglobin A1c (HbA1c) ≥ 6.5%
2. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
3. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)

Exclusion Criteria

1. Persistent visual impairment in one or both eyes;
2. History of macular edema or retinal vascular (vein or artery) occlusion;
3. History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
4. Subject is contraindicated for fundus photography (for example, has light sensitivity);
5. Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
6. Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or
7. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs
8. Subject falls into one of the below categories:

* Adults unable to consent (individuals w/ impaired decision-making capacity)
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes