Optimize Pediatric OCT Imaging

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators plan to enroll 10 healthy adult volunteers and 20 pediatric patients in clinic or undergoing examination under anesthesia. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with our prior investigational imaging with the same system. There is a risk of corneal abrasion with the contact imaging system (Theia imaging), however, this system is used in the setting of other contact imaging systems (such as RetCam fundus photography). Imaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SD/SSOCT Imaging (DARSI) Laboratory. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06139523
Study type	Observational
Source	Duke University
Contact	Xi Chen, MD
Phone	(919)684-8434
Email	xi2.chen@duke.edu
Status	Recruiting
Phase
Start date	January 24, 2024
Completion date	December 2025

View Details

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