Researchers at the OHSU Casey Eye Institute have developed the world’s first handheld ultra-widefield optical coherence tomography (OCT) system for diagnosing retinopathy of prematurity (ROP), aiming to address longstanding limitations in paediatric retinal imaging.
The investigational device, created by a multidisciplinary team at Oregon Health & Science University (OHSU), combines ultra-widefield OCT with artificial intelligence to enable rapid, non-invasive imaging of the retinas of premature infants.
More than 3,000 eye examinations have already been conducted using the system by Dr J. Peter Campbell, Edwin and Josephine Knowles endowed professor of ophthalmology, and Dr Yifan Jian, associate professor of ophthalmology and biomedical engineering.
ROP is the leading cause of childhood blindness worldwide. In the US, approximately 500 infants lose their sight to the condition each year, while globally the figure is estimated at 50,000 annually. Much of this vision loss is considered preventable with timely and accurate diagnosis.
Despite advances in adult retinal imaging, paediatric care has lagged behind.
“When we see kids, the standard of care is still drawing a picture with pencil and paper,” Dr Campbell said. “We’re essentially two decades behind.”
Traditional ROP examinations rely on indirect ophthalmoscopy, requiring manipulation of the infant’s eye with a scleral depressor. This can be stressful for premature infants and may lead to complications such as bradycardia and oxygen desaturation. Diagnosis is also highly subjective, contributing to variation in treatment decisions.
The new handheld system is designed to overcome these challenges. Operating at speeds of 400 to 800 kHz, it captures images of awake, non-sedated infants with a field of view of up to 140 degrees, extending to the ora serrata without the need for a scleral depressor. Images are acquired in approximately one second.
“The eye exam in babies is really hard,” Dr Campbell said. “Your field of view is small, so you spend several minutes creating a mental mosaic. With the new OCT system, we see everything in one second.”
The device was built from the ground up using custom optical components, including specialised lenses and fibres to minimise light loss, along with high-speed computational systems for real-time image processing. According to Dr Campbell, the resulting field of view exceeds that of any adult OCT system currently available in the US.
Development has followed a bench-to-bedside model, with Dr Jian attending neonatal intensive care unit rounds to observe clinical workflows and refine the hardware in response to real-world feedback.
“Being able to work with ophthalmologists and test what we’ve developed in real life, and to see the impact immediately – that’s what drives our research,” Dr Jian said.
Beyond imaging, the system enables a shift from subjective assessment to quantitative diagnosis. The ultra-widefield OCT provides objective measurements of retinal structures, including ridge thickness and volume, with permanent documentation. Integrated AI algorithms segment and analyse images in real time and can be used for autonomous disease detection in telemedicine screening.
“Our long-term goal is to integrate the AI into the OCT, so that you get a great picture and a severity score that makes us all speak the same language,” Dr Campbell said.
The AI component builds on earlier work at OHSU Casey Eye Institute. In 2020, the institute’s i-ROP DL deep learning system received FDA Breakthrough Device designation for diagnosing clinically significant ROP.
Both the imaging system and AI technology are progressing through FDA approval pathways, with commercial availability anticipated within the next year through an OHSU startup company. The team is also developing a second-generation camera aimed at reducing costs while maintaining performance, to support global deployment.
Orbis International, the world’s largest ophthalmic non-government organisation, has invested in the company through venture philanthropy, reflecting the need for scalable telemedicine solutions to address ROP globally. “Our goal is to get a camera into every NICU in the world over the next five to 10 years,” Dr Campbell said.
The technology is also being adapted for other applications, including retinoblastoma screening, uveal melanoma monitoring and intraoperative surgical guidance. In 2024, Dr Campbell received an innovation award at a Cleveland Clinic neonatology conference.
OHSU Casey Eye Institute has played a central role in ROP research for more than four decades, including the first clinical trial in ROP led by Dr Earl Palmer, and contributions to redefining the international classification of ROP under former institute leader Dr Michael Chiang.
“Oregon has punched above its weight in terms of ROP care for forty years,” Dr Campbell said. “If you look at top 10 institutions for ROP impact, we are certainly in the top three or four.”
