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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 1 year
Awards & highlights
Study Summary
This trial is testing a device that uses AI to detect diabetic retinopathy, a common cause of blindness. It aims to make screening easier, faster and more accurate.
Eligible Conditions
- Diabetic Retinopathy
- Diabetes
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
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
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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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cumulative amount of participants enrolled in this research endeavor?
"This clinical trial needs 369 individuals that fulfil the eligibility requirements in order to begin. Participants can register at Lake Nona Research (Orlando, Florida) and The Jackson Clinic (Jackson, Tennessee)."
Answered by AI
Are there any open slots for this clinical investigation?
"As per the information on clinicaltrials.gov, this trial is still ongoing and currently requires new participants. The post was initially published on March 29th 2023 with the most recent update occurring May 4th of that same year."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
What site did they apply to?
Karas Health Care
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been to multiple doctors here in Louisiana with no help, i am determined to see again!
PatientReceived 1 prior treatment
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