New research published in Ophthalmology Science details promising data from a pivotal study evaluating the use of a home-based optical coherence tomography (OCT) system for managing neovascular (wet) age-related macular degeneration (nAMD).
The system in question: Notal Vision’s SCANLY Home OCT.
First, let's get a rundown on this system.
What it is: A device that acts as a self-operated and comprehensive remote patient monitoring service to capture spectral-domain (SD-)OCT images in a 10x10° area centered on the point of fixation.
- The scan time: less than 1 minute per eye
Once captured: These images are immediately transferred via a built-in wireless connection for analysis to the company’s in-house Notal Health Cloud.
Talk about this analysis.
Once the OCT images are received: Notal’s artificial intelligence (AI)-based Notal OCT Analyzer (NOA) then segments and estimates the volume of hyporeflective spaces (HRS) on the images.
A couple of notes:
- About HRS: These are dark areas in the retina visible via OCT
- Why these spaces are key: They are considered critical biomarkers for managing nAMD
- About NOA: This is Notal’s deep-learning algorithm that automatically quantifies retinal fluid—another key biomarker for nAMD treatment efficacy
And what’s the purpose of this image data?
According to Notal: “Physicians can review data, set eye-specific notification criteria, including volume thresholds, and receive notifications through a HIPAA-compliant web portal.”
In other words: This at-home, patient-operated monitoring system provides daily scanning for physicians to remotely monitor and, if needed, treat disease progression.
Now hold up … wasn’t SCANLY already cleared by the FDA?
Indeed it was. The FDA granted De Novo market authorization for the SCANLY in May 2024, actually.
So why is there further research on it?
This prospective, cross-sectional, single-visit study (NCT05202587) was actually the research that led to the FDA’s clearance of the system—notably the first-ever clearance of an AI algorithm applied to OCT images, as Notal has noted.
Ah, gotcha. Tell me about this study, then.
Conducted from Nov. 11, 2021, to Jan 12, 2023, across six U.S. retina clinics, the investigation consisted of:
- Participants: 336 nAMD patients (aged 18+)
- Inclusion criteria:
- Active intraretinal fluid or subretinal fluid
- Best-corrected visual acuity of 20/320 or better
- Inclusion criteria:
- The setup:
- Patients were asked to self-capture four images each on two home OCT devices in clinic with no technical assistance
- Patients were also imaged on an in-office OCT device (CIRRUS 500; Zeiss) for comparison
- Outcome measures: See here for all seven (captured in 5-minute timeframes)
So what was analyzed?
Investigators used the AI algorithm in the home OCT devices to look for HRS in the images—including subretinal and intraretinal spaces and quantified total retinal hyporeflective space (TRO) volumes.
Then: Clinical experts graded both home and in-office OCT images for detecting HRS in the intra- and subretinal compartments.
The two key outcomes under evaluation:
- The repeatability and reproducibility of NOA’s HRS volume estimation using home OCT-captured images as well as by reading center (RC) graders on in-office OCT
- The similarity in HRS volumes segmented by NOA when compared with manual RC graders on home OCT-captured images
And what did they find?
To note: The 336 participants included in the study’s findings were able to successfully perform ≥1 scan with segmentation by Notal’s NOA and an RCC grader.
The results: Strong positive outcomes were observed for the AI algorithm in both areas under evaluation, with Notal Vision reporting:
- The repeatability of TRO estimates from home OCT-captured images and the AI algorithm was actually higher than the repeatability estimates associated with using an in-office OCT imaging device and RC grading
- The agreement of HRS segmentation between AI and graders was no different than the agreement between graders themselves
Interestingly, unlike when in a home environment, a higher number of patients (8% versus 3.9%) failed calibration than in the clinic setting on ≥1 of the 2 OCT imaging devices.
Any specific reasoning for that?
According to the study authors: This may be attributed to a few factors:
- Greater comfort and lower stress in the home environment
- More time available to the patient
- Phone support from the remote monitoring center to assist with calibration
So what were the conclusions?
Overall, the authors determined that their findings supported the use of the SCANLY system as a “reliable tool to estimate the volume of retinal HRS from serial spectral-domain (SD)-OCT scans while monitoring at home between routine clinical visits.”
Senior author Eric Schneider, MD, of Tennessee Retina, noted that the data “should give retina specialists a great deal of confidence in adopting this patient monitoring program."
And how were these findings taken into consideration with the rollout of SCANLY?
The authors added six important notes that were included in the system’s product labeling “to mitigate misinterpretation of the true HRS status.”
- See the complete list here.