Using AI software to diagnose retinopathy of prematurity in infants

Validation of artificial intelligence (AI) based software as medical device (SaMD) for retinopathy of prematurity (ROP)

NIH-funded research Siloam Vision, INC. · NIH-10931442

This study is testing a smart computer program that helps doctors quickly and accurately check for a serious eye condition in premature babies, with the goal of preventing blindness and making sure the program works safely in real-life situations.

Quick facts

Grant typeSbir 2 grant
Study typeNIH-funded research
Funding institutionSiloam Vision, INC. NIH-funded
Lab location1 site (Lake Oswego, United States)
Project IDNIH-10931442 on NIH RePORTER

What this research studies

This research aims to validate an artificial intelligence (AI) software designed to diagnose retinopathy of prematurity (ROP), a serious eye condition that can lead to blindness in premature infants. The AI algorithm analyzes images from a specialized camera to provide expert-level diagnosis quickly and accurately. By integrating this technology into clinical workflows, healthcare providers can receive immediate diagnostic support, potentially preventing blindness in at-risk infants. The project includes updating the AI algorithm for better performance and conducting clinical studies to ensure its effectiveness and safety.

Who could benefit from this research

Good fit: Ideal candidates for this research are premature infants under the age of 11 who are at risk for developing retinopathy of prematurity.

Not a fit: Patients who are not premature or do not have risk factors for retinopathy of prematurity may not benefit from this research.

Why it matters

Potential benefit: If successful, this research could significantly reduce the incidence of preventable blindness in premature infants by enabling timely and accurate diagnosis of ROP.

How similar studies have performed: Previous research has shown success with AI-based diagnostic tools in other medical fields, indicating a promising potential for this novel approach in diagnosing ROP.

Where this research is happening

Lake Oswego, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.