Efficacy of the Notal Vision OCT device demonstrated by a range of scientific and clinical work

NotalVision Inc. reported this week that several scientific and clinical presentations prove the feasibility and efficacy of their patient-operated, home-based optical coherence tomography (OCT) device.

According to the company, the Notal Home OCT (OCT) device, as part of a remote monitoring service, which includes a surveillance center and artificial intelligence algorithms for information processing, monitors the treatment of wet age-related macular degeneration (AMD) between doctor visits.

Wet AMD is the leading cause of blindness in people over the age of 50 in the United States. Over the past 2 decades, several treatments have been developed that have proven to be extremely beneficial. However, therapy requires frequent office visits for disease monitoring, which places a great burden on physicians, patients and their caregivers. This burden has contributed to the limited real-world efficacy of these treatments.

The company noted that home monitoring using standard care OCT technology is expected to optimize treatment regimens for these patients and deliver better vision outcomes. Key challenges for OCT home technology include demonstrated correlation with office devices, full patient self-service, convenient use in a home environment, continuous patient compliance, and the ability to extract meaningful information from the large amounts of data generated . The FDA breakthrough OCT device is a pipeline technology for monitoring wet AMD treatments.

A series of studies using the OCT examination device has shown that the device can effectively overcome each of these challenges. A prospective and cross-sectional study,1 including 333 wet AMD patients and 600 eyes, demonstrated patients’ ability to mold themselves in a clinic setting, with over 91% of patients being able to successfully acquire images without the help of a technician. The imaging showed an excellent correlation with office OCT for detecting the presence of fluid, a key biomarker in wet AMD, with greater than 95% agreement.1

“We were very surprised by Home OCT’s success rate with self-imaging and patient response,” said David Lally, MD, of the Retina Research Institute of New England Retina Consultants, Springfield, Massachusetts. “Patients with limited vision were able to form self-image without assistance, and most patients felt that using the device was much easier than they initially expected. I think after imaging nearly 600 eyes with Home OCT, we can be confident that it can produce reliable images with patient self-service.”

The company also noted in its publication that a prospective and longitudinal study was conducted by leading retina specialists Jeffrey Heier, MD and Nancy Holekamp, ​​MD to gain insights into patients’ self-esteem in a home setting without prior training.2

According to the release, the program took 15 wet AMD patients and the device was shipped to their homes by the Notal Vision Monitoring Center. Subjects were able to set up the device themselves and perform daily scans with support from the Monitoring Center clinical staff.

Patients demonstrated an extraordinary ability to self-image, with a total of 2300 scans performed with a 95% success rate. Yingna Lui, MD recently presented the results of this study at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, which also demonstrated the importance of at-home OCT data for better disease management in patients, involving specific case studies of remote monitoring were assessed. The US study followed a prospective longitudinal pilot study conducted in Israel in 2020 by Anat Loewenstein, MD and colleagues.3

The press release also noted that patient compliance was also examined in the Heier and Holekamp longitudinal study. Patients performed an average of 5.8 exams per week, demonstrating strong compliance to ensure that any fluid exudation, essential for wet AMD treatment, was quickly captured. Patients were asked to rate their satisfaction with the OCT device as part of the study and rated it neutral to very satisfactory on more than 95% of the questions, and strongly agreed on convenience and ease of use.

“The Notal Vision Monitoring Center shipped the device directly to the patients and handled all of their training and patient questions — our site did not provide training,” said Heier, director of retinal service and retina research at Boston Ophthalmic Consultants. “Physicians viewed the device’s AI-generated data using a web-based viewer. This technology has the potential to allow clinicians a daily assessment of fluid status, earlier recognition of recurrent activity, and can reduce the significant burden currently placed on patients, caregivers and their caregivers.”

Home OCT cannot be adopted by physicians without the ability to distil the vast amounts of images generated by the device into actionable information. This process is managed by the AI-powered Notal OCT Analyzer (NOA). Fluid areas captured by Home OCT’s B-scans are segmented and quantified by NOA and these volumes, an important biomarker in wet AMD, are studied over time. The performance of NOA was demonstrated by Michael Elman, MD and Sid Schechet, MD during a 26-patient study they conducted in which self-acquired scans of patients were analyzed using NOA and compared to expert-reviewed commercial OCT scans. The results, presented by Dr. Elman at the ARVO annual meeting, found a high correlation of over 97% between NOA and manually graded OCT scans. This study further demonstrates the capability of the AI-based fluid quantification algorithm in wet AMD patients.

“We are excited to see multiple researchers evaluating different aspects of our Home OCT research platform,” said Kester Nahen, PhD, CEO of Notal Vision. “This is further validation of the effectiveness of our digital health-based remote monitoring model, which we are currently using for the ForeseeHome AMD Monitoring Program. We believe we have perfected the various components of the model over the past ten years, which has helped us tremendously in bringing this impactful technology closer to the market.”

Notal Vision’s home-based OCT pipeline technology has received an FDA Breakthrough Device designation and is in the process of gaining FDA approval. In January 2020, the American Medical Association established three Category III CPT (Current Procedural Terminology) codes for reporting patient-initiated remote retinal OCT scans facilitated by Notal Vision’s home-based OCT.

The review, interpretation and documentation of AI-based analytics by physicians will be billed every 30 days.

References

  1. Kim JE, Tomkins-Netzer O, Elman MJ, Lally DR, et al. Evaluation of a self-image SD-OCT system designed for remote home monitoring. BMC Ophthalmol 22261 (2022). https://doi.org/10.1186/s12886-022-02458-z
  2. Liu Y, Holekamp NM, Heier JS. Prospective, longitudinal study: daily self-imaging with home OCT for neovascular age-related macular degeneration. Ophthalmology Retina2022. https://doi.org/10.1016/j.oret.2022.02.011
  3. Keenan TDL, Goldstein M, Goldenberg D, Zur D, Shulman S, Loewenstein A, Prospective, longitudinal pilot study Daily self-imaging with patient-guided OCT at home in neovascular age-related macular degeneration. Ophthalmology Science2021;1:100034. https://doi.org/10.1016/j.xops.2021.100034

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