Efficacy of Notal Vision Home OCT Proven by a Series of Scientific and Clinical Work

Efficacy of Notal Vision Home OCT Proven by a Series of Scientific and Clinical Work

July 01, 2022

Notal Vision reported that scientific and clinical publications and presentations demonstrate the feasibility and efficacy of their patient-operated, home-based optical coherence tomography (OCT) device.

As part of a comprehensive remote monitoring service, which includes a monitoring center and artificial intelligence algorithms for information processing, the Notal Home OCT is designed to monitor wet age-related macular degeneration (AMD) treatment between doctor’s office visits.

A series of studies using Notal Vision’s Home OCT have shown that the device is effective in overcoming each of these challenges. A prospective and cross-sectional study recently published in BMC Ophthalmology, which included 333 wet AMD patients and 600 eyes, demonstrated the ability of patients to self-image in a clinic setting, with over 91% of patients being able to successfully acquire images without technician assistance.

The imaging showed excellent correlation with in-office OCT for detecting the presence of fluid, an important biomarker in wet AMD, with over 95% agreement.[1]

“We were very surprised by Home OCT’s self-imaging success rate and the patient response,” David Lally, MD from the Retina Research Institute at New England Retina Consultants, Springfield, MA, said in a company news release. “Patients with limited vision were able to self-image with no assistance, and most patients felt that use of the device was much easier than they initially anticipated. I think after imaging nearly 600 eyes with Home OCT, we can be confident in its capability to produce reliable images with patient self-operation.”

A prospective and longitudinal study to understand patients’ ability to self-image in a home setting with no prior training was conducted by retina specialists Jeffrey Heier, MD and Nancy Holekamp, MD.[2] The program enrolled 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 the support of the Monitoring Center clinical staff. Patients demonstrated extraordinary self-imaging capability, with a total of 2,300 scans taken at a 95% success rate.

Yingna Lui, MD recently presented the results from this study at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, which also demonstrated the importance of home-based OCT data for better disease management in patients, reviewing specific remote monitoring case studies. The US study followed a prospective longitudinal pilot study conducted in Israel by Anat Loewenstein, MD and colleagues in 2020 and published in Ophthalmology Science.[3]

Patient compliance was also studied in the Heier and Holekamp longitudinal study. Patients performed an average of 5.8 exams per week, demonstrating compliance to ensure any exudation of fluid was promptly captured. Patients were asked to assess their satisfaction of Home OCT as part of the study and rated it neutral to highly satisfactory on over 95% of questions, and highly agreed on convenience and ease of use.

Notal Vision’s home-based OCT pipeline technology has received an FDA Breakthrough Device designation and is in the process of obtaining FDA clearance. In January 2020 the American Medical Association established three category III Current Procedural Terminology (CPT) codes for reporting patient-initiated remote retinal OCT scans, facilitated by Notal Vision’s home-based OCT. The physician review, interpretation and documentation of AI-based analyses will be billable every 30 days.

References

1. Kim JE, Tomkins-Netzer O, Elman MJ, Lally DR, et al. Evaluation of a self-imaging SD-OCT system designed for remote home monitoring. BMC Ophthalmol 22, 261 (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 Retina, 2022. 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-Operated Home OCT in Neovascular Age-Related Macular Degeneration. Ophthalmology Science 2021;1:100034. https://doi.org/10.1016/j.xops.2021.100034