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Software

AEYE-DS Software for Diabetic Retinopathy

N/A

Recruiting

Research Sponsored by AEYE Health Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of diabetes mellitus meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO): Elevated Hemoglobin A1c (HbA1c) ≥ 6.5%, Fasting Plasma Glucose (FPG) ≥ 126 mg/dL, Oral Glucose Tolerance Test (OGTT) with two hour plasma glucose (2-hr PG) ≥200 mg/dl, Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dl

Be older than 18 years old

Must not have

Uncorrectable vision loss, blurred vision, or floaters

Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a software device called AEYE-DS that can automatically detect a specific eye condition called more than mild Diabetic Retinopathy in adults with diabetes. Participants will have their eyes

Who is the study for?

This trial is for adults with diabetes who may have a condition called Diabetic Retinopathy. Participants will undergo an eye exam where images of their eyes are taken using different cameras. People with certain eye conditions or previous treatments that could affect the study's results cannot join.

What is being tested?

The AEYE-DS Software Device is being tested to see if it can accurately detect a level of Diabetic Retinopathy in diabetic patients by analyzing photos of their eyes taken with various fundoscopy cameras, compared to standard readings by professionals.

What are the potential side effects?

Participants might experience discomfort from the dilation drops used to enlarge pupils for better imaging and potential temporary vision changes due to pupil dilation, but no significant side effects are expected from the software analysis itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diabetes according to ADA/WHO standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have permanent vision problems that can't be fixed.

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I have been diagnosed with a serious retinal condition.

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I have been diagnosed with Diabetic Retinopathy.

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I have had laser treatment or surgery on my retina, or injections in my eye.

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I am currently in a study for an eye condition and receiving treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensitivity and Specificity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AEYE-DS Software DeviceExperimental Treatment1 Intervention

Eligible participants will undergo the following procedures: photographic imaging of each eye using various fundoscopy camera devices. Images obtained will be sent to the AEYE-DS software for analysis. Additional photographic and Optical Coherence Tomography (OCT) images will be obtained using a second fundoscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis. All study subjects will have their pupils dilated using dilation drops.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AEYE-DS Software

2023

N/A

~370

0 / 6Eligibility criteria met