Comparing Two Handheld OCT Systems for Pediatric Retina Imaging A Pilot Study Including Healthy Adults and Children

What this Trial Is About

Handheld optical coherence tomography OCT is an important imaging tool to examine the pediatric retina. This pilot study compares a new contact OCT system Theia Imaging with an investigational noncontact OCT system developed by Duke Biomedical Engineering to evaluate their abilities to image the pediatric retina. Researchers believe the contact OCT may image larger areas of the retina, while both systems have similar image quality for retinal substructures. The study includes 10 healthy adult volunteers and 20 pediatric patients, either in clinic or undergoing examination under anesthesia. This observational study uses two investigational handheld OCT devices the Theia contact system, which offers a wide field of view and rapid imaging speed, and a noncontact system developed at Duke University. Both devices meet safety standards, and imaging data will be securely collected for detailed analysis. Participants will undergo a single imaging session using both OCT systems to capture retinal images. Researchers will assess retinal microanatomy abnormalities and measure retinal thickness at key locations. Data collected will be processed and analyzed in a specialized laboratory. The study aims to gather important imaging information with no known risks besides a small risk of corneal abrasion from the contact device.

Optimize Pediatric OCT Imaging