Ultra-Widefield Optical Coherence Tomography Beyond the Ora Serrata in Retinopathy of Prematurity.

Importance: Capturing high-quality images of the entire peripheral retina while minimizing the use of scleral depression could increase the quality of examinations for retinopathy of prematurity (ROP) while reducing neonatal stress. Objective: To evaluate whether an investigational handheld ultra-widefield optical coherence tomography (UWF-OCT) device without scleral depression can be used to document high-quality images of the peripheral retina for use in ROP examinations. Design, Setting, and Participants: This was a prospective, cross-sectional study in the neonatal intensive care unit at a single academic medical center. Study participants were neonates in the neonatal intensive care unit who met standard ROP screening criteria (birth weight ≤1500 g; gestational age ≤30 weeks). Examinations were performed from January 2, 2023, to May 12, 2024. Data analysis was performed in July 2024. Exposure: An investigational, contact-based, 800-kHz, 140° (visual angle) UWF-OCT field-of-view handheld device was used during regular ROP examinations. Main Outcomes and Measures: Images from each examination were captured using the UWF-OCT device, and the zone, stage, and presence of plus disease were diagnosed. If the UWF-OCT system was unable to capture diagnosis, this was recorded. Results: A total of 507 examinations were performed on 83 neonates (mean [SD] birth weight, 905.1 [362.5] g; mean [SD] gestational age, 189.5 [19.1] days) with this system. The vascular border and disease was able to be visualized in 100% of cases, including to and beyond zone III. In some cases, images were able to clearly demonstrate the ora serrata and even the ciliary body. Conclusions and Relevance: The UWF-OCT device was able to be safely used to perform ROP screenings and subsequent evaluations and provided volumetric imaging of the ora serrata and sometimes the ciliary body. The findings suggest that such devices may be associated with reduced technical challenges of capturing the entire peripheral retina in telemedicine programs, may reduce pain and stress for delicate neonates owing to the reduced use of scleral depression, and, with adaptation of the system, could potentially allow for peripheral imaging of the whole retina in older children and adults.