AEYE-DS Software for Diabetic Retinopathy

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: AEYE Health Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to learn about the performance of the AEYE-DS Software Device to automatically detect more than mild Diabetic Retinopathy (mtmDR) in adult participants diagnosed with Diabetic Mellitus (DM) using fundoscopic images of the eyes. The main question it aims to answer is if the software is effective in diagnosing more than mild Diabetic Retinopathy (mtmDR) in patients with known diabetes using digital funduscopic images, acquired from each of the participating fundoscopy devices and based on one macula centered image per eye. Participants: * will have an eye exam in which photographic images of each eye will be taken by a novice operator, using four different FDA approved/registered fundoscopy cameras. These images will be sent to and analyzed by the AEYE-DS software device. * will have additional eye imaging taken using a different FDA approved desktop camera system by a professional ophthalmic photographer. These images will be sent to an independent reading center for analysis. * will have dilation drops put in their eyes (either during or after the imaging with the fundoscopy cameras), wait about 30 minutes for the pupils to dilate and continue the eye imaging exams. The outcome results with the AEYE-DS Software will be compared to the analysis of the eye images processed by the reading center to see if the investigational software device was accurate in its diagnosis.

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

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

I have been diagnosed with a serious retinal condition.

I have been diagnosed with Diabetic Retinopathy.

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

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

Treatment Details

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.

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.