Monitoring retinal diseases with a high incidence of recurrence, such as neovascular (or “wet”) age-related macular degeneration (nAMD), can be very difficult. A new optical coherence tomography (OCT) scanning device that allows patients to be monitored outside the office could help to alleviate this challenge. In May, the US Food and Drug Administration (FDA) granted de novo marketing authorization to Notal Vision’s artificial intelligence (AI)–powered Scanly Home OCT device.
The Scanly Home OCT Monitoring Program is intended to monitor patients between regularly scheduled office visits. “Wet AMD is a highly heterogeneous disease that is hard to characterize and manage with diagnostic imaging performed weeks or months apart,” says Kester Nahen, PhD, chief executive officer of Notal Vision. “Scanly helps ophthalmologists personalize care for their patients.”
The Scanly Home OCT device can fit on a tabletop for easy, daily patient self-imaging. Image courtesy of Notal Vision.
How the Program Works
The Scanly Home OCT Monitoring Program includes multiple elements. Scanly is a patient-operated device that captures spectral-domain OCT images in a 10° by 10° area, then transmits them wirelessly to the Notal Health Cloud for analysis, explains Dr. Nahen.
As images are received, an assistive AI-based deep learning algorithm called the Notal OCT Analyzer (NOA) segments and estimates the volume of hyporeflective spaces, which typically represent fluid in the retina. The retina specialist can use a web interface to establish biomarker thresholds for each patient, which will trigger a notification when the volume of hyporeflective spaces increases.
Over several clinical trials, Scanly demonstrated very high positive and negative predictive values, making it highly sensitive and accurate.1,2 “Coupling the device with AI-powered image analysis establishes a second layer of surveillance to ensure the highest level of personalized care,” says W. Lloyd Clark, MD, physician at Palmetto Retina Center and Retina Consultants of America, and assistant clinical professor of ophthalmology at University of South Carolina, all in Columbia, South Carolina. Dr. Clark, an investigator for the Scanly clinical trials, notes that in addition to the cumulative AI-generated analysis, clinicians have access to all images.
Ease of Use
The Notal Vision Monitoring Center ships the Scanly device to patients and provides support for setup and operations as needed. The compact device can fit on a tabletop. Scans take approximately 40 seconds, and patients should scan every day, if possible, says Dr. Clark. In clinical trials, more than 98% of images captured were readable, with visual acuities as low as 20/320.1
“Patients place their face in the machine, find the fixation light, and acquire up to 88 B-scan images,” Dr. Clark says. “Patients in nAMD trials found it easy to use and remained compliant.”
User friendliness plays a significant role in whether patients adhere to regular monitoring, Dr. Nahen says. Across multiple longitudinal trials, patients scanned on average close to 6 times per week. Patients who stop using the device receive a reminder via text message or phone calls from the monitoring center.
Benefits Abound
“Consistent disease control is the key to maintaining visual acuity gains in wet AMD,” Dr. Clark says. “That control has required frequent visits to the office and getting injections.” By using the Scanly device at home as prescribed, wet AMD patients should need fewer burdensome office visits, particularly as longer-acting anti-VEGF agents become available. In a clinical trial, chronic nAMD patients self-monitoring with Scanly were able to extend the intervals between injections from 8 to 16 weeks over a 6-month period, without any compromise in visual acuity.3
There are perks for ophthalmologists as well. If nAMD patients are regularly monitored at home, reducing the need for some in-office visits, clinics will have more time available to see other patients. The Notal Vision Monitoring Center manages all elements of the service on a physician’s behalf, including benefits verification, program onboarding, and white-glove patient support.
The Notal Vision Monitoring Center has been successfully monitoring AMD patients remotely for over 10 years. The provider’s ForeseeHome AMD Monitoring Program uses AI to detect the progression of intermediate dry age-related macular degeneration. Now, concludes Dr. Nahen, the Scanly Home OCT Monitoring Program provides a new option for patients with neovascular AMD. RP
References
1. Home OCT fluid visualization agreement study. ClinicalTrials.gov identifier: NCT04907409. Updated March 9, 2022. Accessed July 11, 2024. https://clinicaltrials.gov/study/NCT04907409
2. The evaluation of the agreement between the NVHO in the automatic fluid quantification and cirrus OCT. ClinicalTrials.gov identifier: NCT05202587. Updated February 15, 2023. Accessed July 11, 2024. https://clinicaltrials.gov/study/NCT05202587
3. Holekamp NM, de Beus A, Clark WL, Heier JS. Prospective trial of Home OCT guided management of treatment-experienced nAMD patients. Retina. 2024;44(5). doi:10.1097/IAE.0000000000004167.
