Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images
Public ClinicalTrials.gov record NCT06241664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Clinical Trial to Demonstrate the Efficacy and Safety of the AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images Obtained With Multiple Fundoscopy Camera Devices
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06241664
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 601 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2024 (Actual)
- Primary completion
- Oct 2, 2024 (Actual)
- Completion
- Feb 20, 2025 (Actual)
- Last update posted
- Mar 18, 2025
2024 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trial Network | Houston | Texas | 77074 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06241664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 18, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06241664 live on ClinicalTrials.gov.