Bringing It All Back Home: Reshaping Ophthalmology's Clinic with Home OCT

When a breakthrough therapy receives US Food and Drug Administration (FDA) approval, it represents years of research, clinical trials, and collaboration to bring an additional weapon to the physician’s arsenal. But as revolutionary as these treatments may be, their impact is often inseparable from the tools used to track their effects.

In recent decades in ophthalmology, the story of neovascular (wet) age-related macular degeneration (nAMD) care has been reshaped by the introduction of anti-vascular endothelial growth factor (VEGF) therapies. Optical coherence tomography (OCT) has allowed ophthalmologists to monitor the treatment of these retinal diseases with notable fluid recurrence, including nAMD, by providing a non-invasive imaging technique enabling high-resolution, 3D cross-sectional images using reflected light.

However, traditional OCT devices require a patient with retinal diseases to visit an office, an often time-consuming task, and there is a delay between scans which can lead to disease progression. In May 2024, the US Food and Drug Administration (FDA) granted De Novo authorization to Notal Vision’s patient self-operated home OCT product, Scanly, for the monitoring of retinal diseases at home, including nAMD.

Arshad Khanani, MD, MA
Credit: LinkedIn

This device could provide eye care professionals unprecedented insight into how treatments work in real-time, empowering patients to take a more active role in preserving their vision.

“The FDA approval of home OCT is groundbreaking for our field, as we enter an era of sustained delivery with gene therapy, tyrosine kinase inhibitions, and long-acting anti-VEGF, we don’t know how the disease is doing between the time we are seeing the patient,” Arshad Khanani, MD, MA, director of clinical research at Sierra Eye Associates and a clinical associate professor at the University of Nevada, Reno, told HCPLive. “Home OCT will give us that disease control data and lead to better outcomes where we catch the disease early and treat it before it gets out of hand.”

Since its early-1990s introduction, OCT has revolutionized ophthalmic care. Invented in 1991 by David Huang and colleagues at the department of electrical engineering and computer science of Massachusetts Institute of Technology, its non-invasive technique and ability to detect subtle tissue structure changes have transformed care of nAMD, as well as glaucoma and diabetic retinopathy.

In that time since invention, OCT technology has undergone rapid advancement. Early time-domain systems provided ophthalmologists with modest resolution and speed, while modern spectral-domain and swept-source OCTs have achieved ultra-high resolution (≤5 µm) images, with faster speeds, enabling detailed 3D visualization.

Sri Krishna Mukkamala, MD
Credit: Georgia Retina

Another recent innovation in ophthalmic imaging is OCT angiography (OCTA), allowing for non-invasive images of retinal and choroidal blood vessels, to provide further insight into the microvascular changes in the eye dictating systemic disease. As a cornerstone of ophthalmic care, these capabilities have created new avenues for the clinical utility of OCT for retinal diseases—however, more is still possible, according to leading retina experts.

“The challenge with injections for nAMD is determining the duration between visits is an inexact science and needs to be personalized from patient to patient,” Sri Krishna Mukkamala, MD, a retina specialist at Georgia Retina, told HCPLive. “But, wouldn’t it be excellent if we could provide patients with an in-home device that can monitor their OCT scan and level of retinal disease activity on a day-to-day basis, so we know precisely how long an individual treatment is working in their particular eye?”

A patient-operated device, Scanly was designed for at-home monitoring of retinal fluid using spectral-domain OCT technology. The Scanly system captures at-home OCT images in a 10x10-degree area centered on the point of fixation with the small form factor device. An artificial intelligence (AI)–based algorithm then analyzes the segment to estimate the volume of hyporeflective spaces.

Using these estimates, clinicians may be able to efficiently monitor patients with retinal diseases, particularly hyporeflective spaces equivalent to intraretinal and subretinal fluid.

Eric W. Schneider, MD
Credit: Tennessee Retina

“You’re looking at trends in the volume of hyporeflective spaces, which we’re considering equivalent to fluid over time, and that’s where you get the most efficient way to monitor these patients over time,” Eric W. Schneider, MD, a retina specialist at Tennessee Retina, told HCPLive. “I want to emphasize that it’s more a system than a single device, because either alone isn’t nearly as helpful as it would be paired together.”

Two pivotal trials in the US, encompassing more than 500 patients, led to the approval of Scanly. In a longitudinal pivotal study of patients with nAMD, who had an average age of 77 years, approximately 97% of the study population successfully collected at-home OCT images.

Overall, 5,426 scans in the study eye were performed, with a successful adherence rate of 5.9 scans per week and self-imaging taking an average of 48 seconds. An analysis of data comparing in-office to at-home scans revealed excellent agreement, meeting a pre-specified endpoint for positive and negative agreement (≥80%).

Importantly, the device was identified as easy to use, with few troubleshooting calls from patients in the study placed to the vision monitoring center.

“This is the epitome of personalized retinal care, with an individual patient, an individual eye, and an individual disease,” Mukkamala added. “Knowing that information, we can really provide personalized care for that patient’s eye, for that disease, and optimize their visual outcome and reduce their treatment burden.”

Further analysis revealed positive effects for the repeatability and agreement of the home OCT device’s AI-based algorithm versus in-office OCT.

These data showed both the in-office and home OCT devices achieved good precision on the fluid volume scans, with a lower variability with the home OCT. Meanwhile, the volume estimation for total hyporeflective spaces was relatively similar between the AI-based volume scans compared with the reading center graders.

“We should see an impact initially, if we look at fields like cardiology or endocrinology as an example, where they had home monitoring devices, we didn’t see a downturn in their in-office diagnostics,” Schneider told HCPLive. “I think it’s important that we tell patients what the device does. It monitors for these hyporeflective spaces, not a retinal detachment, but there is still a robust monitoring component.”

Within this decade, ophthalmology has been at the center of a boom in new, longer-acting medicines, including the FDA approval of faricimab (Vabysmo) and aflibercept 8 mg (Eylea HD), the approval of intraocular drug delivery systems, including the Port Delivery System with ranibizumab (Susvimo), and further innovations, including TKIs and gene therapies.

“For the first time in many years, there are several new injectable medicines that have longer durability and greater effectiveness for the management of nAMD,” Mukkamala said. “The issue with longer-durability drugs is that patients are in the office less often to monitor their disease activity—I think the advent of the FDA-approved home OCT came at exactly the right moment.”

Given the ease of use and ability to extend the time between trips to the office, home OCT could play a critical role in monitoring and reducing the burden of treatment in patients with retinal diseases, transforming the future of care in ophthalmology.

“The important thing it will do is decrease the treatment burden. Sometimes patients come to our clinic completely dry and we’re able to comfortably extend the treatment interval by using home OCT,” Khanani added. “Home OCT will be adapted broadly as we embark on this journey of utilizing new generation agents for our patients with nAMD.”

References:

1. FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization. May 16, 2024. Accessed December 6, 2024. https://notalvision.com/assets/press-releases/May-16-2024-FDA-Grants-AI-Powered-Notal-Vision-Home-OCT-22SCANLY22-De-Novo-Marketing-Authorization.pdf.
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