New findings published in RETINA detail the first-of-its-kind prospective clinical trial on Notal Vision’s home-based optical coherence tomography (OCT) system for managing neovascular (wet) age-related macular degeneration (AMD).
Let’s start with this OCT system.
The Scanly Home OCT device is designed as a self-operated and comprehensive remote patient monitoring service that captures spectral-domain (SD-)OCT images in a 10x10° area centered on the point of fixation.
- The scan time: less than 1 minute per eye
Then: Once a patient captures these images, they’re immediately transferred through a built-in wireless connection for analysis via the company’s in-house Notal Health Cloud.
What kind of analysis is done on them?
The AI-based Notal OCT analyzer (NOA) then “segments and estimates the volume of hypo-reflective spaces (HRS)”—which are key biomarkers for managing wet AMD—on the OCT images.
To know: NOA is Notal’s deep learning-based algorithm for automatic quantification of retinal fluid (yet another key biomarker for wet AMD treatment efficacy).
And how is this different from the ForeseeHome?
Unlike Notal Vision's FDA-cleared, remote-based ForeeSeeHome program, which supports early wet AMD detection—see here for details on that, including on the HOme Monitoring of the Eye (HOME) study—the SCANLY device is intended for wet AMD treatment monitoring.
I’m up to date! So what’s the Scanly device's clinical status?
Funny you should ask … the system was recently (as in, April 2024) granted De Novo marketing authorization by the FDA.
- Refresh: A De Novo classification provides a marketing pathway to classify medical devices—with no predicate device already legally marketed for the same use—that “provide reasonable assurance of safety and effectiveness for the intended use.”
Now talk about this study.
Approved by an Institutional Review Board (adhering to FDA regulations), this interventional trial examined the impact of the Scanly Home OCT device when used for at-home wet AMD patient management on treatment burden and visual outcomes.
- What was studied: Comparison of treatment frequency and visual acuity (VA) for patients both before and during use of the home OCT device (received through the Notal Vision Monitoring Center)
- Note: No device training was provided for patients prior to use; all patients were also treated with injections during this time
- Participants: 15 patients (with wet AMD in at least one eye)
- In total: 21 eyes under evaluation
- Study period: 6 months
- Measurement outcomes: Patients’ adherence to regular scanning measured via number of scans performed on weekly basis
- Per the home OCT device process: All self-acquired scans were uploaded to the secure cloud and reviewed by study investigators
How exactly were these outcomes measured?
Both treatment frequency and VA outcomes were assessed and compared to patients’ previous standard-of-care data—dating all the way back to their wet AMD diagnosis (within a max of 2 years), according to Notal Vision.
Now these findings.
Overall, Notal Vision stated, “the reported results demonstrated a significant reduction in office visits and treatment frequency.”
- Case in point: The mean treatment interval increased from 8 weeks to 15.3 weeks
- Comparatively: The mean VA remained stable
Give me those stats.
VA changes both before and during home OCT use demonstrated no significant impact:
- Before: 3.5 (12.0) letters (p = 0.45)
- During: 0.0 (9.5) letters (p = 0.45)
How many scans per week did patients conduct?
On average: 6.2 times per week/per eye.
Meaning: Patient adherence and successful use of the device was reasonably high among all participants.
Let’s talk more numbers.
By the end of the study, a total of 4,435 scans were performed by participants—with 91.2% eligible for an AI-based fluid volume quantification.
- Total number of monitoring weeks prior to study: 1,555
- Total number of monitoring weeks during the study: 509
- Mean (SD) number of weeks per injection before home OCT: 8.0 (4.7) (p = 0.004)
- Mean number of weeks per injection during home OCT: 15.3 (8.5)(p = 0.004)
Expert opinion?
The study authors concluded that “For the first time, remote patient monitoring with a home OCT allowed personalized management” of wet AMD.
Plus: This promising data noted a significant reduction in treatment burden while still maintaining stable VA—a major win for wet AMD management.
Editorial note: This article was updated on June 28, 2024, and July 1, 2024.