Home OCT Device Scanly Receives FDA Approval for Remote Monitoring of Retinal Diseases
核心洞察
Notal Vision (搜索)'s Scanly (搜索), a patient self-operated home OCT device, has received FDA De Novo authorization for monitoring retinal diseases like nAMD (搜索).
Scanly (搜索) allows for frequent at-home monitoring of retinal fluid, potentially providing eye care professionals with real-time insights into treatment effectiveness.
Clinical trials demonstrated high patient adherence and agreement between at-home Scanly (搜索) images and in-office OCT scans, suggesting ease of use and reliability.
The FDA has approved Notal Vision (搜索)’s Scanly (搜索), a home-based optical coherence tomography (OCT) device, for monitoring retinal diseases, including neovascular (wet) age-related macular degeneration (nAMD (搜索)). This approval marks a significant step toward personalized retinal care, enabling patients to monitor their condition from home and potentially improve treatment outcomes. The device allows for frequent, convenient monitoring, addressing the limitations of traditional in-office OCT scans.
Revolutionizing Retinal Disease Management with Home OCT
Traditional OCT, since its introduction in the early 1990s, has transformed ophthalmic care by providing non-invasive, high-resolution 3D images of the retina. However, the need for frequent office visits can be burdensome for patients and may lead to delays in detecting disease progression. Scanly (搜索) aims to bridge this gap by allowing patients to perform OCT scans at home, providing eye care professionals with more frequent data points to optimize treatment strategies.
Arshad Khanani, MD, MA, director of clinical research at Sierra Eye Associates, noted the importance of this advancement, stating, "The FDA approval of home OCT is groundbreaking for our field... 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."
Scanly: Technology and Clinical Validation
Scanly (搜索) utilizes spectral-domain OCT technology to capture images of the retina. The device is designed for patient self-operation, capturing images in a 10x10-degree area centered on the point of fixation. An artificial intelligence (AI)-based algorithm analyzes the images to estimate the volume of hyporeflective spaces, which are indicative of intraretinal and subretinal fluid.
Two pivotal US trials, involving over 500 patients, supported the FDA approval. A longitudinal study of nAMD (搜索) patients, with an average age of 77 years, showed that approximately 97% of participants successfully collected at-home OCT images. Patients completed an average of 5.9 scans per week, with each self-imaging session taking approximately 48 seconds. Data analysis revealed excellent agreement between in-office and at-home scans, meeting pre-specified endpoints for positive and negative agreement (≥80%).
Impact on Personalized Retinal Care
The integration of home OCT into retinal disease management has the potential to significantly reduce treatment burden and improve patient outcomes. Sri Krishna Mukkamala, MD, a retina specialist at Georgia Retina, emphasized the personalized aspect of this technology: "This is the epitome of personalized retinal care, with an individual patient, an individual eye, and an individual disease... 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."
Furthermore, the repeatability and agreement of Scanly (搜索)'s AI-based algorithm with in-office OCT were demonstrated in further analysis. The home OCT device showed good precision in fluid volume scans, with lower variability compared to in-office OCT. Volume estimation for total hyporeflective spaces was also similar between AI-based scans and reading center graders.
Future Implications for Ophthalmology
The approval of Scanly (搜索) coincides with the introduction of new, longer-acting medications for retinal diseases, such as faricimab (Vabysmo) and aflibercept 8 mg (Eylea HD (搜索)). These longer-acting treatments reduce the frequency of office visits, making home monitoring even more crucial. As Eric W. Schneider, MD, a retina specialist at Tennessee Retina, noted, home OCT can complement in-office diagnostics by providing continuous monitoring of retinal fluid levels.
With its ease of use and ability to extend the time between office visits, home OCT is poised to play a critical role in transforming the future of care in ophthalmology, offering a more convenient and personalized approach to managing retinal diseases.