Ophthalmologists who follow patients with retinal disease are familiar with a pattern of care regarding patients who are being monitored for intermediate AMD (iAMD). That patient is given an Amsler grid, is educated on how to use it and is instructed to return to the clinic if new metamorphopsia is detected. Even with a perfectly compliant patient, such self-monitoring with the Amsler grid is often ineffective at detecting changes from new underlying neovascular AMD (nAMD). Sometimes, patients return to my clinic for their regularly scheduled appointments having unknowingly converted to nAMD seemingly months earlier. This delay in presentation makes a significant negative impact on the long-term visual prognosis.

In a perfect world, ophthalmologists would monitor iAMD patients quite often, maybe even monthly, for visual and anatomic changes. In the real world, however, monthly visits to the retina clinic are impractical. Given the acute nature of a conversion from iAMD to nAMD, monthly monitoring may not even be sufficient to detect disease progression in some cases.

Enter an at-home monitoring provider of digital health services that allows clinicians to receive information from their iAMD patients’ visual function status changes that occur between office visits. By supplementing routine exams with at-home monitoring, patients may increase the likelihood that progression to nAMD will be detected early, allowing for the earlier prompt treatment that is needed and associated with the most optimal outcomes.

HOW IT WORKS

Digital diagnostic services help usher ophthalmology into the age of AI and digital medicine, giving clinicians the opportunity to offer remote personalized care between office visits that is pegged to individual patient characteristics. Such individualized care may lead to earlier disease intervention and more targeted therapy.

When a clinician determines that a patient has iAMD, they may consider enrolling their patients in the ForeseeHome AMD Monitoring Program, which is provided by the Notal Vision Diagnostic Clinic at no cost to the practice. Patients using the FDA-cleared and Medicare-covered ForeseeHome platform in their home perform a preferential hyperacuity perimetry test every day on the device.

An AI-based algorithm automatically analyzes data transmitted to a secure health cloud operated by the medical provider. Aberration from baseline — suggesting that a patient has moved from iAMD to nAMD — and most recent visual field test results are reviewed by in-house ophthalmologists at the remote Diagnostic Clinic for quality control purposes.

The referring doctor’s practice receives an alert via an email that contains a direct link to the patient’s report in question so the doctor can determine the best course of action. If a read receipt is not received, the Diagnostic Clinic escalates the alert and calls the practice. No one from the Diagnostic Clinic contacts the patient directly, thus sustaining the doctor-patient line of communication.

Although the concierge services of the Notal Vision Diagnostic Clinic allow a patient to essentially stay in constant contact with their provider’s office, the impact on the day-to-day work of a practice is small (see “Leave the heavy lifting to someone else,” below).

Clinicians who are interested in a particular patient’s profile have 24/7 access to daily testing data via an online portal, allowing doctors to track results at time points they deem relevant. For those who wish to have regular updates, the monthly patient summaries emailed to the referring practice could prove useful. The review of remote perimetric data during office visits can support the identification and interpretation of early changes seen on OCT and OCT angiography scans. Physicians can review test compliance and encourage frequent use of the device, which supports efficacy of the detection algorithm.

Remember that, just as in-clinic monitoring alone may be insufficient to detect progression to nAMD in some patients, a strictly at-home monitoring regimen is inadequate for disease monitoring. A sophisticated digital model for disease monitoring includes both in-person examination and use of at-home platforms.

REVIEW OF THE LATEST DATA

Findings of two recent pieces of literature underscore the utility of referring iAMD patients to the Notal Vision Diagnostic Clinic for the ForeseeHome AMD Monitoring Program.

A 2020 retrospective review of real-world data in the AAO IRIS Registry found that patients with nAMD who presented with at least 20/40 VA at baseline maintained a mean VA of at least 20/40 after 1 and 2 years of anti-VEGF therapy.¹ Eyes that presented with less than 20/40 VA did not reach mean 20/40 VA at 1 or 2 years. Approximately 34% of eyes presented with VA of at least 20/40, meaning that a large majority (ie, ~66%) of patients present with VA poor enough that they are unlikely to return to 20/40 vision even after 2 years of anti-VEGF therapy.

In a 2021 study, researchers examined patient data housed in the Notal Vision Diagnostic Clinic.² Their retrospective review included patients whose VA was at least 20/60 at the time the ForeseeHome platform was prescribed. Patients in the study were monitored for disease progression by both the device and by in-person examination conducted routinely or when symptoms presented.

Among patients who fit the enrollment criteria, 306 converted from iAMD to nAMD. Approximately 69% of patients who converted to nAMD had disease detected by the ForeseeHome platform. Median baseline VA for patients in the study was 20/25-2. By the time nAMD was detected, median VA was 20/32-1.

Of the 306 patients who converted to nAMD in that study, 109 had at least 20/40 VA at baseline, 81% of whom retained at least 20/40 VA when disease activity was detected. Given the aforementioned findings from the IRIS Registry study that baseline 20/40 VA at the time of disease detection is the cutoff for maintaining 20/40 VA after 1 or 2 years of therapy, it is noteworthy that 81% of new nAMD patients with at least 20/40 VA whose disease was detected after adding at-home testing to their monitoring regimen were able to initiate therapy before their VA dipped below the cutoff point. These positive findings are a stark contrast to the aforementioned 34% in the IRIS registry, which reflect the performance of standard of care that typically includes only use of an Amsler grid. Of note, a recent real-world analysis of the ForeseeHome platform showed possible lower adherence rates that would impact utility of the device.³ While the data collection and analysis is debated, emphasis on proper compliance can lead to more effective monitoring.⁴

Armed with these data sets, clinicians should feel confident that the care they provide when referring patients to the Notal Vision Diagnostic Clinic for a home-monitoring program is likely to detect disease earlier and save more patients’ functional vision than current standard of care. Both the patient and the physician should be comforted knowing that everything is being done to ensure the patient is receiving the best preventative care possible.

THE FUTURE OF DIGITAL HEALTH CARE

Patients and clinicians may be more familiar than they realize with digital health in other fields of comprehensive care.

Consider the iCare Home (iCare USA), a home-based tonometer that allows patients to perform diurnal self-monitoring of IOP. Outside of ophthalmology, constant glucose monitoring (CGM) has been employed for years by patients with diabetes. Some CGM technologies even deliver insulin at a continuous rate based on real-time blood glucose levels. Additionally, wearable devices in the cardiovascular space continuously monitor heart rates and rhythm to assess for intermittent occult disease. Lastly, we have recently seen a huge growth of digital monitoring platforms for COVID-19 surveillance on smartphones, watches and more.

Exciting new macula-monitoring technologies include the Home Vision Monitor (formerly “myVisiontrack,” Roche-Genentech),⁵ the King-Devick Variable Color Contrast Sensitivity Chart,⁶ Alleye (Oculocare)⁷ and OdySight (Novartis).⁸ These modalities are designed for patients to more easily monitor their AMD more consistently with a potentially higher sensitivity for detecting any possible changes to nAMD. The underlying science behind these monitoring systems are more advanced that the standard Amsler Grid, but they are only as helpful as the patient’s compliance with the need to use them daily.

A successful remote monitoring solution relies on both technology and patient engagement. The Notal Vision Diagnostic Clinic is an ophthalmologist-led clinic staffed by certified ophthalmic professionals that partners with physician offices and engages patients remotely. The Diagnostic Clinic staff initiates contact with the patient over the phone, provides the ForeseeHome device, educates patients about AMD, teaches them how to use the device, monitors test compliance and provides compliance coaching as needed. For clinicians, the Notal Vision Diagnostic Clinic analyzes test data, and provides reports and alert notifications. The remote patient engagement helps reduce valuable chair time in the office.

The Notal Vision Diagnostic Clinic monitors test compliance. If a patient does not demonstrate frequent use or if a pause on use is detected, the Notal Vision Diagnostic Clinic reaches out to the patient to ensure their wellness and help troubleshoot any potential technical issues. This service leads to high rates of patient retention and is tailored to an elderly population that may not be comfortable with new technology. It also ensures that the prescribing physician does not have to add compliance monitoring to their practice’s task list.

The future of such frameworks is closer than we might think. The increasing ubiquity of smartwatches seemed like a science fiction dream only a few years ago, and their ability to synthesize any number of biometric data points from a central diagnostic center could be closer than we imagine. Monitoring devices such as smart contact lenses that slowly release therapeutic agents or track longitudinal IOP data are on the horizon as well.

HOME OCT

Another such remote diagnostic technology is in-home OCT. Images from patient self-operated OCT devices and tracked changes in disease activity are expected to add a new dimension to the management of patients with exudative retinal diseases. Daily self-imaging will give us new insights in disease dynamics and treatment response.

To make large amounts of image data manageable for clinicians, artificial intelligence-based image analysis algorithms are needed to identify and quantify actionable biomarkers: for example, fluid volume in the intra- and subretinal space. The online review of temporal fluid volume trajectories will allow treating physicians to set specific alert thresholds that providers of such monitoring services will identify and inform the physician when the criteria has been met.

The physician-led utilization of remote OCT data will enable new proactive, highly personalized treatment regimens. We will be able to perform intravitreal injections responding to each individual eye’s level of disease activity in an agile fashion. Patients with good treatment response may benefit from extended retreatment intervals over the safety net of Home OCT. Fluid alerts in eyes with early recurrence will prompt remote review of OCT images, potential office visits for further testing and decision to treat. Such treatment paradigm will potentially reduce fluid exposure to the retina while reducing the burden that office visits and treatments create for patients and caregivers and as such promote the adherence and persistence to intravitreal anti-VEGF therapy.

At the American Society of Retina Specialists 2020 Virtual Annual Meeting, Dr. Judy Kim presented data on the Notal Vision Notal Home OCT & Analyzer’s ability to identify and quantify retinal fluid in output of a patient self-operated home OCT device. Her team found that AI performed comparably to human readers, showing the Home OCT’s potential to accurately monitor AMD disease activity at home.⁹ With several longitudinal home OCT studies in nAMD (and DME) currently under way, we are at the brink of a new paradigm-shift in disease management.

KEEPING THE PATIENT AS CLOSE AS POSSIBLE

Ophthalmologists can’t see their patients at all times, but they can keep them within the orbit of a practice thanks to remote monitoring services. These providers connect patients to a network of patient engagement specialists and AI-driven algorithms that form a comprehensive eye-care service ecosystem. The ability to promptly detect conversion from iAMD to nAMD could be the difference between your patients maintaining functional vision or having a suboptimal ceiling for visual potential under therapy.

Improved monitoring between office visits for potential conversion to exudative AMD will help us better personalize iAMD management and improve visual outcomes with earlier treatment when it is needed. OM

REFERENCES

1. Ho AC, Kleinman DM, Lum FC, et al. Baseline visual acuity at wet AMD diagnosis predicts long-term vision outcomes: an analysis of the IRIS registry. Ophthalmic Surg Lasers Imaging Retina. 2020;51(11):633-639.
2. Ho AC, Heier JS, Holekamp NM, et al. Real-World performance of a self-operated home monitoring system for early detection of neovascular age-related macular degeneration. J Clin Med. 2021;10(7):1355.
3. Yu HJ, Kiernan DF, Eichenbaum D, Sheth VS, Wykoff CC. Home Monitoring of Age-Related Macular Degeneration: Utility of the ForeseeHome Device for Detection of Neovascularization. Ophthalmol Retina. 2021 Apr;5(4):348-356.
4. Clemons TE, Elman MJ, Garfinkel RA, Kim JE. Re: Yu et al.: Home Monitoring of Age-Related Macular Degeneration: Real-World Utility of the ForeseeHome Device for Detection of Neovascularization. Ophthalmol Retina. 2021;5(1):e1.
5. Kaiser PK, Wang YZ, He YG, et al. Feasibility of a novel remote daily monitoring system for age-related macular degeneration using mobile handheld devices. Retina. 2013;33:1863-1870.
6. Ittiara S, Hariprasad AS, Messner LV, et al. Use of the King-Devick Variable Color Contrast Sensitivity Chart to differentiate stages of age-related macular degeneration. BMJ Open Ophthalmol. 2020;5(1):e000451.
7. Islam M, Sansome S, Das R, et al. Smartphone-based remote monitoring of vision in macular disease enables early detection of worsening pathology and need for intravitreal therapy. BMJ Health Care Inform. 2021;28(1):e100310.
8. Brucker J, Bhatia V, Sahel JA, Girmens JF, Mohand-Saïd S. OdySight: a mobile medical application designed for remote monitoring-a prospective study comparison with standard clinical eye tests. Ophthalmol Ther. 2019;8(3):461-476.
9. Kim JE, Lally DR, Elman MJ, et al. Performance of a Novel Deep Learning Algorithm for Automatic Retinal Fluid Quantification in Home OCT Images. Presented during the ASRS 2020 Virtual Annual Meeting, July 24-26, 2020.

About the Author

Sidney A. Schechet, MD, is in private practice at the Elman Retina Group, PA, in Baltimore, Md.

Disclosure: Dr. Schechet is a consultant for Notal Vision.