Data from a 10-year study published in Ophthalmology Retina assessed the long-term visual acuity (VA) and performance of a vision-monitoring strategy using Notal Vision Inc.’s ForeseeHome AMD Monitoring Program for the detection of wet age-related macular degeneration (nAMD).
To offer a more in-depth look at the study results, Glance President Jackie Garlich, OD, FAAO, spoke with Notal Vision’s Megan L. Blemker, OD, director, Clinical Affairs & Education.
Let’s start with this program.
The ForeseeHome AMD Monitoring Program is an FDA-cleared, remote, artificial intelligence (AI)-enabled device used to assist eyecare professionals (ECPs) in the conversion from dry intermediate to wet AMD.
The device is based on proprietary, patented technology called preferential hyperacuity perimetry (PHP)—a psychophysical test used to identify and quantify visual abnormalities—that is 10x more sensitive than Snellen acuity.
How does it work?
ForeseeHome is designed as a short, easy-to-use test for patients to conduct on a regular basis, acting “as a safety net between their regularly-scheduled exams,” according to Dr. Blemker.
Once a test is complete, the data is automatically sent to the Notal Vision Monitoring Center—a remote ophthalmic monitoring center run by practicing ophthalmologists.
If the device’s AI detects a statistically significant change in the patient’s central visual field (including metamorphopsia), their referring physician’s practice receives an alert.
Dr. Blemker explains how the process works for participating clinical practices and patients (and click here to learn more).
What’s the clinical data on it?
The HOme Monitoring of the Eye (HOME) study, an unmasked, multicenter, controlled, randomized clinical trial (RCT) conducted by the National Eye Institute (NEI) and ancillary to the Age-Related Eye Diseases Study 2 (AREDS2) study, led to the FDA clearance and Medicare coverage of the program.
Supporting data from the real-world, a retrospective review of the ALOFT (Analysis of the Long-term Visual Outcomes of ForeseeHome Remote Telemonitoring) study was also published in 2022.
Dr. Blemker offers more details on this, below.
Talk about this review.
Investigators in the ALOFT review evaluated the medical records of 2,123 patients (3,334 eyes), with a mean age of 74 years, who were monitored with the ForeseeHome device from August 2010 to July 2020.
They took note of the following outcome measures:
- Visual acuity (VA) at baseline
- VA at diagnosis of nAMD (for eyes converted while monitored)
- VA from final study follow-up
- Weekly frequency of use
- Duration of monitoring
- System alert vs standard care detection
- Duration and number of treatments (since conversion to final study follow-up)
Patients reported persistent use of the ForeseeHome device, with an average of 5.2 times a week. Additionally, 82% had a VA of 20/40 or better at their most recent eye exam.
What was the conversion rate?
A total of 285 eyes (85%) converted to wet AMD during the monitoring period (with an annual rate of 2.72%) and were treated with an average of 17.3 injections over an average of 2.7 years (mean of 6.4 injections per year for eyes treated for less than 1 year).
Go on …
Per the study authors, 52% of these detected conversions had a system alert from the monitoring center, while 48% of patients were detected via symptoms or routine visit. To note, the proportion of eyes that maintained ≥ 20/40 at conversion and the final follow-up was:
- Conversion: 84% (78% → 88%)
- Follow-up: 82% (76% → 86%)
The authors noted that prequalification information on the number of prescriptions filled by the study patients was not collected. Further, VA data was only available for 30% to 40% of eyes that did not convert and VA measurement methods were of standard clinical care (Snellen charts).
Lastly, information was not collected for the types of drugs used for treatment and the management scheme.
The study authors stated that, based on the data, “patients who participated in the ForeseeHome (FSH) monitoring program showed excellent VA at the time of conversion to nAMD, were treated consistently, and maintained good vision long term.”
They concluded that this emphasized the importance of early detection and treatment for AMD.