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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with diabetes according to ADA/WHO standards.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensitivity and Specificity
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
Find a Location
Who is running the clinical trial?
A. Stein Regulatory Affairs Consulting Ltd.UNKNOWN
AEYE Health IncLead Sponsor
2 Previous Clinical Trials
894 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any available slots for new participants in this medical trial?
"According to information available on clinicaltrials.gov, the ongoing medical research study is currently not seeking new participants. The trial was first listed on January 31st, 2024 and last updated on January 29th, 2024. Despite this specific trial being closed for enrollment, there are currently 103 other clinical trials actively recruiting patients at present."
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