Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-02

Study Completion Date

2025-12-31

Brief Summary

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To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.

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Detailed Description

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Operator took fundus images with a non-mydriatic fundus camera as per the Retina-AI CheckEye imaging protocol (an optic disc centered image and a fovea centered image for each eye).Thereafter, operator uploaded fundus images in the AI system for processing by the neural network.

Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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main group

have diabetes mellitus

taking fundus photos using non-mydriatic fundus camera

Intervention Type DEVICE

using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.

control group

have risk factors for developing diabetes mellitus

taking fundus photos using non-mydriatic fundus camera

Intervention Type DEVICE

using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.

Interventions

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taking fundus photos using non-mydriatic fundus camera

using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Documented diagnosis of diabetes mellitus by definition.
2. Understanding of the Study and willingness and ability to sign informed consent
3. Patient age 18 or above
4. Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes

Exclusion Criteria

-1. Patients under 18 years of age; 2. Failure to give informed consent; 3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.

4\. A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes