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Remote monitoring reduces office visit and treatment burden in some patients.
August 12, 2024
By: Michael Barbella
Managing Editor
Notal Vision is sharing encouraging results from the first prospective clinical trial using home-based optical coherence tomography (OCT) to manage neovascular age-related macular degeneration (nvAMD) patients. Published in RETINA, the data show a significant reduction in office visits and treatment frequency, while visual acuity remained stable. An Institutional Review Board (IRB)-approved trial enrolled 15 patients with nvAMD in at least one eye from three U.S. retina specialist practices. A total of 21 eyes in the study were managed with home OCT over six months. The patients received the home OCT device through the Notal Vision Monitoring Center, which also provided virtual support and patient education. Patients did not receive any training in their doctor’s offices on using the device. The self-acquired scans were automatically uploaded to a secure cloud and reviewed periodically by the study investigators. Physicians set time and structural biomarker-based thresholds to prompt notifications and assist in timely data review. Treatment frequency and visual acuity outcomes were compared to the patients’ own past standard of care data, dating back to their nvAMD diagnosis with a two-year maximum. The reported results demonstrated a significant reduction in office visits and treatment frequency with the mean treatment interval increasing from eight to 15.3 weeks. The mean visual acuity remained stable.1 The investigators also looked at patient adherence and ability to successfully use the device. Patient adherence to home OCT use was high, with on average 6.2 scans per week in each eye.1 The trial follows a series of home OCT based studies that have demonstrated nvAMD patients’ ability to self-image conveniently at home over extended periods. Notal Vision is a patient-centric ophthalmic remote monitoring services provider extending retinal disease monitoring from the clinic to the home, providing physicians with remote monitoring services to support their patient care between office visits. With an approach to home-based, self-operated diagnostics, AI-enabled data analysis, and patient engagement, the company aims to help doctors preserve patients’ vision. The Notal Vision Monitoring Center (NVMC) is a remote, Medicare credentialed ophthalmic monitoring center and the epicenter of patient engagement. Led by practicing ophthalmologists and supported by certified ophthalmic professionals, the Monitoring Center offers a nationwide age-related macular degeneration (AMD) home monitoring service for patients. The ForeseeHome AMD Monitoring Program is a comprehensive program, which includes a U.S. Food and Drug Administration-cleared device that monitors visual changes in intermediate dry AMD patients at risk of vision loss from undiagnosed wet AMD. With the addition of the SCANLY Home OCT system to the Notal Vision family of monitoring products, wet AMD patients can perform technician-free OCT scanning at home with rapid and self-guided fixation—critical components, especially for elderly patients frequently with pre-existing vision loss. The Notal Vision Monitoring Center provides patient data to the physician through the online SCANLY Portal. Physicians are provided 24/7 access to all their patients’ B-scan images from each SCANLY Home OCT scan with the location of the hypo-reflective spaces annotated on each B-scan. The Notal OCT Analyzer (NOA), a proprietary machine learning algorithm, performs automated analysis of the Home OCT scans and generates a report to the physician when a physician specified change is detected. Following physician receipt of a change notification, a patient may be brought to the office for further evaluation if warranted. Reference 1 Holekamp, Nancy M., et al. “Prospective trial of Home OCT guided management of treatment experienced nAMD patients.” RETINA (2024): 10-1097. DOI: 10.1097/IAE.0000000000004167
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