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AI-based Software Device
AEYE-DS Software for Diabetic Retinopathy
N/A
Waitlist Available
Research Sponsored by AEYE Health Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a computer program called AEYE-DS that helps doctors find early signs of eye damage in diabetic patients by looking at pictures of their eyes. The goal is to make it easier for these patients to get regular eye check-ups.
Eligible Conditions
- Diabetic Retinopathy
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AEYE-DS Software
2023
N/A
~370
Find a Location
Who is running the clinical trial?
AEYE Health IncLead Sponsor
2 Previous Clinical Trials
1,106 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
1,106 Patients Enrolled for Diabetic Retinopathy
AEYE Health LLCLead Sponsor
1 Previous Clinical Trials
531 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
531 Patients Enrolled for Diabetic Retinopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with diabetic retinopathy in the past.You have had a type of glaucoma called angle-closure glaucoma or narrow anterior chamber angles in the past.You have permanent vision loss that can't be fixed with glasses, or you have blurry vision or see floaters in your vision.You have been diagnosed with serious eye conditions like macular edema, severe non-proliferative retinopathy, or other retinal issues.You have had laser treatment, injections, or surgery on your eyes in the past.You have been diagnosed with diabetes according to the American Diabetes Association and World Health Organization criteria.You are very sensitive to light.You have had photodynamic therapy recently.You are taking medicine that makes your skin sensitive to sunlight.You are 22 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: AEYE-DS Software Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05857943 — N/A
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