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