AEYE-DS Software for Diabetic Retinopathy

This trial tests a new software, AEYE-DS, designed to detect more than mild diabetic retinopathy, a common eye problem in people with diabetes. The trial evaluates whether the software can accurately diagnose this condition using eye images. Participants with diabetes who have not been diagnosed with diabetic retinopathy and have no significant vision issues are suitable for this trial. Eye images will be taken with different cameras and compared to analyses by eye specialists to assess the software's effectiveness. As an unphased trial, this study allows participants to contribute to innovative research that could enhance early detection of diabetic retinopathy.

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medication that causes photosensitivity (sensitivity to light), you may not be eligible to participate.

Research has shown that the AEYE-DS Software safely and effectively detects diabetic retinopathy, a diabetes-related eye condition, by analyzing eye images. This software examines pictures taken by various eye cameras to identify signs of the condition.

The software's safety appears promising. It is non-invasive, meaning it doesn't touch or affect the body directly. Instead, it analyzes images taken by FDA-approved cameras, reducing the risk of physical harm or discomfort.

Additionally, the software accurately detects more-than-mild diabetic retinopathy. Studies have demonstrated a high sensitivity of 93% (correctly identifying 93 out of 100 people with the condition) and a specificity of 91.4% (correctly identifying 91.4 out of 100 people without the condition). These results suggest the software reliably finds the condition without causing harm.

Unlike traditional treatments for diabetic retinopathy, which often involve invasive procedures like laser therapy or injections, AEYE-DS Software offers a non-invasive, tech-driven approach. This software analyzes images of the retina taken with specialized cameras to detect signs of the condition, making the process simpler and potentially faster. Researchers are excited because this method could streamline the diagnosis process, allowing for earlier detection and management, ultimately improving patient outcomes.

Research has shown that the AEYE-DS Software, used by participants in this trial, effectively detects more-than-mild diabetic retinopathy. In one study, the software correctly identified 93 out of 100 individuals with the condition and accurately recognized 91 out of 100 without it. This indicates the software excels at both detecting diabetic retinopathy and minimizing false alarms. These findings suggest that AEYE-DS could serve as a reliable tool for screening diabetic retinopathy.¹²³⁵⁶