NCT06241664Completed
Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images
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
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 601 (actual)
- First submitted
- 21 Jan 2024
- Start date
- 31 Jan 2024
- Primary completion date
- 2 Oct 2024
- Lead sponsor
- AEYE Health Inc
- Diseases
- Diabetic eye disease
- NCT number
- NCT06241664
What you commit to
- Study type: Interventional
- Participants enrolled: 601
- From 31 Jan 2024 to the primary completion date, 2 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- Previously diagnosed with Diabetic Retinopathy.
- Currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
- Subject has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
Other illness
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- Subject is contraindicated for imaging by fundus imaging systems used in the study:
- Subject is hypersensitive to light
- Subject recently underwent photodynamic therapy (PDT)
- Subject is taking medication that causes photosensitivity
- Subject has a history of angle-closure glaucoma or narrow anterior chamber angles
Other
- Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
- Subject is pregnant
Who the study is looking for
- Male or female, Age≥22
- 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% (48mmol/mol), based on repeated assessments, performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications Trial (DCCT) assay OR
- Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L), based on repeated assessments, where \'fasting\' is defined as no caloric intake for at least 8 hours OR
- Oral Glucose Tolerance Test (OGTT) with two hour plasma glucose (2-hr PG) ≥200 mg/dl (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water OR
- Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dl (11.1 mmol/L)
- Understand the study and volunteer to sign the informed consent
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trial Network Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.