Imagine a groundbreaking leap forward in the diagnosis of retinopathy of prematurity (ROP), a major cause of childhood blindness globally. Researchers at the Oregon Health & Science University (OHSU) Casey Eye Institute have unveiled an innovative handheld ultra-widefield optical coherence tomography (OCT) system specifically designed to revolutionize the way we diagnose this condition, effectively addressing long-standing challenges in pediatric retinal imaging.
This pioneering device is the product of a collaborative effort by a diverse team at OHSU and integrates advanced ultra-widefield OCT technology with artificial intelligence. Its purpose? To facilitate quick, non-invasive imaging of the retinas in premature infants, a group that is particularly vulnerable to visual impairments.
So far, over 3,000 eye examinations utilizing this new system have been successfully performed by Dr. J. Peter Campbell, who holds the Edwin and Josephine Knowles endowed professorship in ophthalmology, along with Dr. Yifan Jian, an associate professor specializing in both ophthalmology and biomedical engineering.
The urgency behind this development cannot be overstated. ROP is currently the leading cause of preventable childhood blindness worldwide, with around 500 infants in the United States alone losing their sight each year due to this condition. On a global scale, this figure escalates to an alarming estimated 50,000 annually. Timely and accurate diagnosis plays a crucial role in preventing much of this vision loss.
Despite significant advancements in retinal imaging for adults, pediatric care has lagged significantly. "When we assess children, the standard approach still resembles sketching a scene with pencil and paper," remarks Dr. Campbell. "We find ourselves nearly two decades behind in our methods."
Conventional examinations for ROP often rely on indirect ophthalmoscopy, which necessitates physically manipulating the infant’s eye using a scleral depressor. This technique can prove stressful for fragile premature infants and carries risks of complications such as bradycardia and oxygen desaturation. Furthermore, because the diagnosis relies heavily on the clinician's judgment, it can lead to inconsistencies in treatment decisions.
The newly designed handheld system aims to surmount these obstacles. Operating at impressive speeds between 400 and 800 kHz, it allows for the capture of images from awake, unsedated infants, offering a remarkable field of view of up to 140 degrees, reaching all the way to the ora serrata without needing a scleral depressor. Remarkably, image acquisition takes just about one second.
"Examining the eyes of babies is quite challenging," Dr. Campbell explains. "The limited field of view requires several minutes to piece together a mental mosaic of what you see. With our state-of-the-art OCT system, we can visualize everything almost instantaneously."
The device was meticulously engineered from scratch, featuring custom optical components including specialized lenses and fibers designed to minimize light loss, along with high-speed computational systems that facilitate real-time image processing. According to Dr. Campbell, the field of view achieved by this device surpasses that of any existing adult OCT system available in the United States.
Development of this innovative technology has adhered to a bench-to-bedside model. Dr. Jian has actively participated in neonatal intensive care unit rounds, observing clinical workflows closely to make hardware refinements based on real-world feedback.
"Collaborating with ophthalmologists and testing our developments in practical settings while witnessing immediate impacts is truly what fuels our research, " Dr. Jian adds.
Beyond mere imaging capabilities, this system represents a critical transition from subjective assessments to quantitative diagnoses. The ultra-widefield OCT provides objective metrics regarding retinal structures, such as ridge thickness and volume, with the added benefit of permanent documentation. Integrated AI algorithms enable image segmentation and analysis in real time, paving the way for autonomous disease detection during telemedicine screenings.
"Our ultimate ambition is to seamlessly integrate AI within the OCT system, ensuring that users receive not only high-quality images but also a severity score that standardizes communication across the board," states Dr. Campbell.
The AI component builds on previous research conducted at the OHSU Casey Eye Institute. Notably, in 2020, the institute's i-ROP DL deep learning system received FDA Breakthrough Device designation for its ability to diagnose clinically significant ROP.
Both the imaging system and its corresponding AI technology are currently advancing through the FDA approval process, with commercial availability expected within the next year via a startup company affiliated with OHSU. Moreover, the team is also in the process of developing a second-generation camera designed to reduce costs while maintaining efficiency, aimed at facilitating global access to this life-saving technology.
Orbis International, recognized as the largest ophthalmic non-governmental organization in the world, has made a financial commitment to this startup through venture philanthropy, underscoring the urgent need for scalable telemedicine solutions that address ROP on a global scale. "Our aspiration is to place a camera in every neonatal intensive care unit around the world within the next five to ten years," emphasizes Dr. Campbell.
In addition to its primary focus on ROP, the technology is being tailored for broader applications such as screening for retinoblastoma, monitoring uveal melanoma, and providing intraoperative surgical guidance. In recognition of these advancements, Dr. Campbell was honored with an innovation award at a neonatology conference hosted by the Cleveland Clinic in 2024.
For over forty years, the OHSU Casey Eye Institute has been at the forefront of ROP research, initiating the first clinical trial in this area under the leadership of Dr. Earl Palmer, and playing a significant role in redefining the international classification of ROP with contributions from former institute leader Dr. Michael Chiang.
"Oregon has consistently exceeded expectations in terms of ROP care over the last four decades," Dr. Campbell asserts. "If you were to rank institutions by their impact on ROP, we would undoubtedly be among the top three or four."
This revolutionary development raises important questions about the future of pediatric retinal care: How will these advancements change the landscape of ROP diagnosis and treatment? Are we ready to embrace technology that could save the vision of thousands of infants? Share your thoughts and let us engage in this critical conversation.
