Home-use AMD device increases efficacy of chair time, patient monitoring

Editor’s Note: Welcome to “Eye Catching: Let's Chat,” a blog series featuring contributions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The views expressed in these blogs are those of their respective contributors and do not represent the views of Ophthalmology Times or UBM Medica. This is part two of a three-part Clinical Innovations series discussing the benefits of incorporating an at-home monitoring system for patients with AMD. Joshua Mali, MD, is a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL.

Early detection, followed by immediate treatment, is key to achieving the best possible outcomes for patients with wet age-related macular degeneration (AMD).ⁱ

Therefore, monitoring these patients to detect the progression from dry to wet AMD is integral to preserving their vision. Due to the fact that patients are more likely to convert to wet AMD between scheduled follow-up appointments with their primary eye-care physician, home monitoring is a valuable extension of in-office clinical care that allows us to detect wet AMD at the earliest possible moment.

This permits earlier treatment of a less-aggressive disease, potentially reducing the intravitreal injection treatment burden and dramatically improving visual outcomes. Aside from the obvious visual acuity benefit, at-home monitoring can also alleviate patients’ anxiety about their disease, as they find comfort knowing that I am watching and monitoring their AMD on a daily basis.

There are currently two methods to monitor vision outside the clinic. One is the Amsler grid, the current standard of care, that is essentially a straight-lined piece of paper with a fixation point in the center. The efficacy of the Amsler grid has been called into question often, given that its sensitivity varies from patient to patient and even from test to test.ⁱⁱ

Given all our 21st-century advances in technology and medicine, it is time for our technology to revolutionize the way we monitor a disease like AMD. Therefore, a more advanced technology, preferential hyperacuity perimetry (PHP), is now available in a device (ForeseeHome, Notal Vision).

The device was found to be so effective that the clinical trial to demonstrate its efficacy ended early given such a positive impact on visual outcomes in AMD patients.ⁱⁱⁱ

In addition, the device can relieve patients’ anxiety as they find comfort knowing that an objective, highly sensitive device is monitoring their vision regularly and will detect changes in their vision and alert me directly if needed.

Increased efficacy of chair time and patient monitoring

The data reports from the device allow me to streamline patient visits and focus on any alerts and concerns. My patients use the device a minimum of eight times per month (although daily use is encouraged) and I check each report once a month. If the patient gets an alert or if I see something of concern during my routine clinical examination, I can cross-reference the report to my clinical exam findings to help me manage individual care appropriately. These reports are a helpful adjunct to optical coherence tomography (OCT) and other standard in-office clinical techniques and diagnostic imaging tools.

Prior to the device, the only options we had to monitor and treat dry AMD was the Amsler grid, AREDS2 vitamins, a good diet, regular exercise, utilizing sunglasses, and cessation of smoking. When one is considering the Amsler grid, it is possible to run into significant patient compliance issues. Often, patients may forget to use the grid or do not use it correctly. This has made it difficult for me to truly know if my patients are effectively monitoring their vision at home.

This device produces reports that display data and information about the patients’ proper usage of the device and records how frequently they are testing, thus allowing me to have the ability to analyze their individualized compliance rates with them at appointments.

There are several advantages to the strategy of more frequent at-home monitoring with the device. As patients test with greater frequency, the algorithm becomes more fine-tuned and accurate, which can allow an increase in the likelihood that choroidal neovascularization (CNV) is discovered at the earliest possible moment. Of note, while the device has received Medicare coverage, there is a requirement through Medicare that the patient must use the device at least eight times per month or they will have to return it due to non-compliance. This provides a major incentive to use the device regularly and consistently. As a result, traditional patient compliance issues are therefore typically minimized.

Alert frequency and management

Alerts that do not detect a conversion to wet AMD (“non-CNV alert”) are generally not an issue. Overall, I have had less than five patients with a non-CNV alert, and with more than 100 of my patients actively testing on the device, this represents a relatively insignificant factor given the overall benefit. When an alert does occur, my office will contact the patient and schedule a follow-up visit typically within 24 to 48 hours.

Once the patient comes into the office, he or she is given a full dilated ophthalmic examination of both eyes including an optical coherence tomography (OCT) scan and fluorescein angiogram (FA). If there is no evidence of CNV, then I can conclude that the alert was a non-CNV alert.
When this is the case, I typically still bring the patient back for a follow-up examination in about four weeks as I am aware of cases in the clinical trial where the device had alerted, but pathology was subclinical and therefore not immediately detectable until later when there was more clinical progression. I take these device alerts very seriously and keep a close eye on any patient who has a non-CNV alert, although, to date, I have not yet had a non-CNV alert convert to a CNV lesion.

While some physicians may be hesitant to institute a new device into their clinical practice regimen–given that they may already feel overwhelmed in the clinic with current office logistics and concerns that a new technology will be an added burden¬–I have found and strongly believe that the benefits of prescribing the device far surpass any inconvenience. The company is helpful with all the logistics, including contacting patients to verify insurance/benefits, organize device delivery, training, troubleshooting, and general customer service. Given the role that the company plays, much of the burden is removed from the eye-care professional.

Ultimately, a physician’s job is to give our patients the best quality of care possible. If we have patients who are eligible to receive the device, they should be given the opportunity to learn more about it and be enrolled in the device program. The ideal candidates are intermediate dry AMD patients with a visual acuity of at least 20/60 in the testing eye. For those who do not meet the vision requirement or cannot baseline with the device, the Amsler grid is still a good choice to monitor these patients.

Joshua Mali, MD, is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL. He can be reached at 941-923-2020. 

Disclosures:

Dr. Mali is currently a consultant and speaker for Notal Vision, Inc.

References:

ⁱHo AC, Albini TA, Brown DM, et al. The potential importance of detection of neovascular age-related macular degeneration when visual acuity is relatively good. JAMA Ophthalmol. 20171;135:268-273.

ⁱⁱAchard OA, et al. Role of the Completion Phenomenon in the Evaluation of Amsler Grid Results. Am Journal of Ophthalmol. 1995;120:322-329.

ⁱⁱⁱAREDS2-HOME Study Research Group, Chew EY, Clemons TE, Bressler SB, et al. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the Eye (HOME) study. Ophthalmology. 2014;121:535-44.