Retina specialists’ have great concern for elderly patients who are at a higher risk for severe illness during the COVID-19 pandemic. Among this population, wet age-related macular degeneration (AMD) is the leading cause of blindness in developed countries. Early detection of wet AMD and continuous monitoring of the disease are crucial to maintaining a patient’s functional vision and, more importantly, quality of life. However, during the pandemic, there has been an urgent need to avoid having these most susceptible AMD patients visit physicians’ offices for their AMD monitoring, due to potential exposure to a life-threatening illness.

AVAILABLE REMOTE MONITORING SOLUTIONS

The COVID-19 pandemic has led ophthalmic practices to reschedule patient follow-up appointments and push back important eye examinations. In many cases, patients at risk of developing wet AMD are unable to receive routine care. There are a few remote monitoring options currently available for these patients, reducing their need to be out in public along with their risk of exposure to COVID-19.

The Amsler grid is part of retina specialists’ standard-of-care protocol. However, for many patients, vision loss is irreversible by the time wet AMD is detected using standard methods like the Amsler grid. Studies have found only 9% to 41% of newly diagnosed patients with choroidal neovascularization (CNV) are detected early with good functional vision (≥20/40),^1-3 and that testing with Amsler grid alone is not effective.³ Choroidal neovascularization may be present for 6 to 12 months before detection and treatment, meaning that when a distortion is noticed on the Amsler grid, vision loss may have already progressed.⁴ It is difficult for physicians to rely on patients to report distortions, because compliance is often poor and difficult to verify. More advanced technology is available that overcomes many of the limitations presented with use of the Amsler grid.

The ForeseeHome AMD Monitoring Program is a home-based monitoring program for intermediate dry AMD patients that helps detect wet AMD earlier, so treatment can be initiated earlier. The AREDS2-HOME study, sponsored by the National Eye Institute, demonstrated that in patients using ForeseeHome, 94% of patients who progressed to wet AMD retained ≥20/40 vision vs 62% of patients using only standard detection methods, like Amsler grid.⁵ The independent data safety and monitoring committee in this study stopped the trial early due to the efficacy of ForeseeHome usage; patients using the device had significantly fewer letters of vision loss at incident CNV compared to standard care alone.

ForeseeHome uses preferential hyperacuity perimetry (PHP) to detect tiny changes in the central visual field, including metamorphopsia and scotomas. Patients are instructed to test their prescribed eye(s) daily, and their responses are automatically transmitted to the Notal Vision Diagnostic Clinic, an independent diagnostic testing facility and medical service provider of ForeseeHome, at the end of each test. The data are then made available to the physician through a secure website.

Tests are continuously compared to a normative database threshold and the patient’s own baseline. When a statistically significant change of test patterns is detected, the remote independent diagnostic testing facility alerts the practice so they can schedule a prompt examination with the patient. With many practices only seeing urgent and emergent cases during the pandemic, ForeseeHome alerts can help determine which dry AMD patients are critical enough to bring into the office. Practices that refer patients to the remote independent diagnostic testing facility can rely on the patient engagement, education, device setup, support, and compliance monitoring the clinic provides over the phone and via email.

ForeseeHome can be particularly beneficial for retina specialists already treating patients with wet AMD in one eye. These patients are most at risk for an increased incidence and progression of AMD in the fellow eye. As some practices try to push anti-VEGF retreatment intervals out further than usual, fellow eyes with intermediate AMD are at a greater risk of undetected conversion for an extended period of time. The use of ForeseeHome on unilateral wet AMD patients can help prevent vision loss in their fellow eye by detecting a conversion to wet AMD earlier.

REMOTE MONITORING SOLUTIONS ON THE HORIZON

The novel coronavirus has added a daunting obstacle in the management of retinal diseases like wet AMD. Patients and physicians are faced with weighing the risks of possible contamination at a medical office or hospital against possible loss of vision due to undertreatment from missed or delayed appointments. In a time when everyone needs to stay home, especially the elderly, home-based OCT monitoring could be the answer in the near future.

Notal Vision is developing an artificial intelligence-enabled, home-based OCT system for patients with wet AMD. The patient-operated, lightweight OCT device is designed for technician-free operation by elderly wet AMD patients at home. A 2019 usability trial with this investigational device in the United States and Israel demonstrated that 90% of AMD patients with >20/400 visual acuity could self-operate and generate analyzable images following a 2-minute tutorial (Figure 1).⁶ Once a patient completes the test, an investigational proprietary machine-learning algorithm, the Notal OCT Analyzer (NOA), performs an automated analysis. If retinal fluid is detected, a report is generated by NOA and conveyed to the treating physician, helping to reduce the time from fluid onset to the next treatment.

Results from a recent international study showed that the areas of fluid seen on home OCT intraretinal and subretinal fluid thickness maps correlated well with the locations of abnormal vessels seen on in-office OCT angiography as well as leakage areas on fluorescein angiography, demonstrating the technology’s potential ability to track disease status.⁷ Home-based OCT may allow physicians to better assess retreatment intervals and catch retinal fluid as soon as it occurs, rather than at the patient’s next clinic visit, which may be pushed further out because of current events. Physicians typically treat patients with a treat-and-extend protocol, and a home-based OCT could facilitate this.

Changes that retina specialists need to make to their practice in a postpandemic world will not be temporary. A home-based OCT could dramatically reduce the extent of exposure of patients to the clinic, expedite their visits, and, more importantly, help physicians decide which patients might be able to reschedule their visits.

In a recent statement, the American Society of Retina Specialists (ASRS) said, “In certain circumstances, it may be determined that injection therapy would be best delivered outside of the clinic and in the patient’s living facility. Centers for Medicare and Medicaid Services (CMS) restrictions for home visits have been reduced.”⁸ A home-based OCT could be beneficial for authorized physicians to determine which patients may need treatment administered at home, further reducing patient exposure to COVID-19. In Israel, retina specialists have started to perform in-home intravitreal injections for selected patients in response to the pandemic.

Notal Vision’s home-based OCT is currently for investigational use only and is not commercially available, but received an FDA Breakthrough Device designation at the end of 2018 and is in the process of obtaining FDA clearance. Other companies looking to develop home OCT devices include Visotec and Acucela. In January 2020, the American Medical Association established 3 category III Current Procedural Terminology (CPT) codes for reporting patient-initiated remote retinal OCT scans.

CONCLUSION

There is not a more important time than now for remote monitoring in ophthalmology, especially for elderly patients. There are solutions available immediately, but the most effective include advanced technology and a holistic approach for patient engagement. The US government has put out a call to bring telemedicine tools to market, and retina specialists are hopeful that this crisis will help expedite the introduction of remote monitoring technologies into patients’ homes. RP

REFERENCES

1. IVAN Study Investigators, Chakravarthy U, Harding SP, et al. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology. 2012;119(7):1399-1411.
2. Notal Vision. Data on file. 2017.
3. Loewenstein A, Malach R, Goldstein M, et al. Replacing the Amsler grid: a new method for monitoring patients with age-related macular degeneration. Ophthalmology. 2003;110(5):966-970.
4. Ho AC, Albini TA, Brown DM, Boyer DS, Regillo CD, Heier JS. The potential importance of detection of neovascular age-related macular degeneration when visual acuity is relatively good. JAMA Ophthalmol. 2017;135(3):268-273.
5. AREDS2-HOME Study Research Group, Chew EY, Clemons TE, et al. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the Eye (HOME) study. Ophthalmology. 2014;121(2):535-544.
6. Notal Vision clinical trial data. On file. 2019.
7. Notal Vision clinical trial data. On file. 2020.
8. American Society of Retina Specialists. COVID-19: updates and resources. Accessed May 5, 2020. https://www.asrs.org/practice/asrs-member-alert-regarding-covid-19-pandemic