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NCT06241664 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images
A NA study of Diabetic Retinopathy (DR) and Diabetic Mellitus, sponsored by AEYE Health.
- Completed
- Registry status
- NA
- Development phase
- 601
- Enrollment target
- 1
- Study location
NCT06241664: Completed NA study of Diabetic Retinopathy (DR) and Diabetic Mellitus, sponsored by AEYE Health.
NCT06241664 is a NA study of Diabetic Retinopathy (DR) and Diabetic Mellitus that has completed, run by AEYE Health. The registered enrollment target is 601 participants, above the 389-participant average among 5 other Diabetic Retinopathy (DR) trials with a reported enrollment target (54% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06241664, a NA study of Diabetic Retinopathy (DR) and Diabetic Mellitus, has completed, sponsored by AEYE Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 601 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To assess the sensitivity and specificity of the AEYE-DS software device for the detection of more than mild diabetic retinopathy (mtmDR) on digital funduscopic images, acquired from each of the participating fundoscopy devices and based on one macula centered image per eye, in subjects with known diabetes undergoing screening for diabetic retinopathy.
Conditions Studied
Interventions
- DEVICE AEYE-DS Software
Study Locations (1)
Texas
- Clinical Trial Network - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2025-02-20 |
| Phase | NA |
What the finished NCT06241664 record still lists
NCT06241664 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, above the 389-participant average among 5 other Diabetic Retinopathy (DR) trials with a reported enrollment target (54% higher).
The record links to 2 conditions, with Diabetic Retinopathy (DR) appearing as the primary indexed condition, and to 1 intervention - of which AEYE-DS Software is the first listed.
NCT06241664 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06241664 about?
NCT06241664 is a clinical study titled "Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images". 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 i...
What is the current status of trial NCT06241664?
This trial is currently completed. It is a NA study. The enrollment target is 601 participants. The study started on 2024-01-31. Estimated completion is 2025-02-20.
What conditions does trial NCT06241664 study?
This clinical trial studies the following conditions: Diabetic Retinopathy (DR), Diabetic Mellitus.
What interventions are being tested in trial NCT06241664?
The interventions under investigation include: AEYE-DS Software (DEVICE).
Who is sponsoring clinical trial NCT06241664?
This trial is sponsored by AEYE Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06241664 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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