In 1947, a Helena, Montana biophysicist strapped on an 85-pound backpack loaded with electronics, climbed aboard a stationary bike, and began pedaling to record the first heart activity in a nonstationary position. It would take several decades before the technology was available to shrink the backpack that Norman Holter stuffed with electronics into the pocket-sized, battery-powered heart rate and rhythm monitor that bears his name.
Today, thanks to broad wireless communication access, seamless high-speed data transfer, artificial intelligence, miniaturization, and reduced cost of components, technology is advancing medical innovation at lightning speed. What once took decades to develop and bring to market now happens in, well, the blink of an eye.
For ophthalmologists, technology is ushering in an era of diagnostic home testing. Patients with age-related macular degeneration (AMD) can now monitor their disease from home, while smartphone apps are helping physicians detect early-stage diabetes-related retinopathy, test visual acuity (VA) and contrast sensitivity, and even monitor cataracts.
With an aging population, the prevalence of AMD is expected to increase, and more high-tech, home-diagnostic tools are on the horizon, including one that will test for retinal vein occlusion and myopic retinopathy. The BrightFocus Foundation, a nonprofit organization that supports research to end Alzheimer disease, macular degeneration, and glaucoma estimates that by 2050, nearly 22 million Americans will have some form of AMD, up from 20 million today. With a health care system already straining under high costs, home diagnostic testing may help ease that pressure while delivering better vision outcomes.
“We’re in a transitional period regarding home diagnostic testing,” says Susan Orr, OD, chief medical officer of Notal Vision, a medical device hardware manufacturer and health care provider. “I see the future of medicine relying more and more heavily on testing extending from the office to the patient’s home.”
Perhaps the most exciting new technology for retina specialists is Notal Vision’s ForeseeHome Monitoring System. ForeseeHome is a cloud-based monitoring system that targets patients with intermediate dry AMD, all of whom are at risk for conversion to wet AMD.
In 2010, the AREDS2 Home Vision Monitoring of the Eye (HOME) Study, conducted by the National Eye Institute, evaluated home testing with ForeseeHome compared to standard of care. It proved so effective relative to the control group that the trial was stopped for efficacy and the product green-lighted for reimbursement by the Centers for Medicare & Medicaid Services.
“It is the only study that I know of in retina that has ever been stopped early because the treatment group did so much better than the control group,” says John Kitchens, MD, a partner at Retina Associates of Kentucky whose practice was part of the study.
The HOME study, enrolling 1,520 patients with intermediate AMD, found that 94 percent of the participants who used the monitoring device at least twice a week and converted from dry to wet AMD maintained 20/40 vision or better at diagnosis, compared to 62 percent of patients diagnosed during a routine eye exam with or without symptoms. In addition, patients using ForeseeHome had a 6-letter VA benefit at conversion when beginning treatment compared to those in the control arm.
“This has an amazingly great benefit for patients if you look at the trial data,” says Daniel Kiernan, MD, who has prescribed ForeseeHome for hundreds of patients at Ophthalmic Consultants of Long Island over the past 2 years. “If your patients are going to be recommended vitamins, [recommending] this goes hand-in-hand with that.”
Until recently, the only way retina specialists could monitor their patients’ dry AMD was through appointments at 4-, 6-, or 12-month intervals, depending on the patient’s risk factors. Between visits, patients were encouraged to use the Amsler Grid to keep tabs on their disease.
But dry-to-wet AMD conversion can happen in a matter of days or weeks, with most patients being totally unaware of the change. Research data shows the earlier the conversion is diagnosed, the better the vision outcome for a patient with treatment.
“You protect the real estate of the macula by diagnosing [wet AMD] early,” Dr. Orr says. “You can start treatment later, but you can never recover all the lost vision because the retina is damaged. Median area was 0.23 disc areas (0.58 mm2) for lesions detected with ForeseeHome in the HOME study - that is really small.” ForeseeHome requires a prescription. The patient is then connected to a ForeseeHome clinical partner at Notal Vision’s Diagnostic Clinic who guides them through the onboarding process, and the device is shipped immediately after that call.
When the patient receives the ForeseeHome device, the clinical partner guides them through a step-by-step setup process and use instructions. ForeseeHome also comes with audio, video, and written instructions. Getting the device up and running isn’t difficult, Dr. Orr says.
“If you’ve ever bought a Mac, you take it out of the box, plug it in and it works,” Dr. Orr says. “This is the exact same thing. It is designed for someone who has never touched a computer. You take it out of the shipping package, set it up, plug it in, press the big button, and voila.”
Still, some older patients who have cognitive issues, or have difficulty with fine motor skills, can find setting up and using ForeseeHome to be a challenge. Dr. Kiernan says a few of his patients have reported difficulty keeping up with the program. But, he says, most patients are happy with it once they get acclimated.
“I tell every patient it is a straightforward device,” Dr. Kiernan says. “The vast majority of my patients, as long as they are motivated to just try, get along just fine.”
Using the device requires that patients establish a baseline. Patients must test each eye for roughly 3 minutes per eye. In Dr. Kitchens’ experience, 10% to 20% of his patients cannot establish a baseline. But for the 80% to 90% who can, “there really is nothing better.”
Medicare covers the cost of ForeseeHome, but it requires that patients use the device 8 times a month to obtain the benefit of testing consistent with the HOME study. Notal Vision also monitors the program. If patients aren’t using their ForeseeHome monitor twice a week, a patient engagement specialist will reach out and encourage them to test their eyes.
ForeseeHome uses Preferential Hyperacuity Perimetry (PHP), a patented technology that can detect minute changes in vision between eye examinations. The program, says Dr. Kiernan, presents patients with an artificial area of distortion that they click on.
“If they have a real area of distortion due to exudative neovascularization resulting from onset of wet macular degeneration, they tend to start picking that area over the artificial area,” he says.
If a change in an eye is detected, the program will automatically recheck the area. If the results are consistent, the physician is alerted by Notal’s clinic staff and the patient is brought in for evaluation.
“Patient response to this is really fantastic,” Dr. Kitchens says. “They are some of my happiest patients. It creates a feeling of action on behalf of the patient. With this, you are actually empowering them.”
ForeseeHome is currently available in test markets across the country. The company expects to launch a national sales force sometime in the next year.
ForeseeHome is currently the “gold standard” in home diagnostic-testing, says Dr. Kitchens. The only thing better, he says, would be home-based optical coherence tomography (OCT) that would allow physicians to see the anatomy of a patient’s eye.
As it turns out, home OCT diagnostic testing may not be too far off.
“In terms of a home OCT product, which is in development, we are in the clinic and have met with the [FDA],” Dr. Orr says. “We have a clear development path and we are planning to launch in the first half of 2020.”
The Notal OCT Analyzer (NOA) is a proprietary artificial intelligence algorithm that automatically analyzes OCT B-scans and identifies the presence or absence of fluid. Like ForeseeHome, The Notal Clinic staff will notify physicians of changes in their patients testing between scheduled eye exams.
“We are targeting wet AMD, diabetic macular edema, and retinal vein occlusion,” says Dr. Orr.
In July, Oculocare, a tech startup company founded in 2015 with the goal of creating new medical software applications for AMD, received FDA 501(K) clearance for Alleye, a mobile medical software program. The software is designed to detect at-risk patients with macular conditions, including AMD and diabetic retinopathy.
The software is built to detect and characterize central and paracentral metamorphopsia. Along with AMD, it can identify diabetic macular edema and central retinal vein occlusion. The product has gone through 5 scientific studies with several hundred subjects taking more than 25,000 measurements that resulted in Alleye having a 91% to 93% true positive rate. The product was made available in Europe in 2017.
Alleye works through an integrated app on smartphones or tablets. Patients must align the middle of 3 dots on an invisible line. The test takes a few minutes for each eye. Test results are scored and color coded. The score measures how accurately the patient performed the test, while the color coding compares current to previous results — better, worse, or the same. The physician can access the test results on a web application in their office. Alleye is recommended for screening healthy and at-risk patients 60 years old and older, as well as monitoring patients with dry AMD and wet AMD. To use Alleye, physicians must register their practice or clinic as an Alleye reseller.
In August, EyeQue, a vision technology company, announced that it was adding color vision and contrast sensitivity testing to its EyeQue Insight product. EyeQue Insight, which became available in March, is a mobile application, binocular, cloud-based service that works through a smartphone to allow users to test their vision at any time. The program is designed to screen eyesight in children, adults, and older adults.
After downloading the app and activating their account, users are guided through instructions on how to start the program. Patients must buy the EyeQue Personal Vision Tracker, or miniscope ($29.99), and the viewfinder-like goggles for EyeQue Insight ($89.99).
Both EyeQue products attach to a smartphone. Using the goggles, patients will see the letter “E” pointing in one of 4 directions. They then swipe in the direction of the open end of the “E.” There is a series of 3 tests - right eye, left eye, dual eye. The test measures visual acuity, color vision, and contrast sensitivity, which the company says can be used for cataract monitoring. The VA test varies for the childrens’ and adult versions of the test. Both tests take approximately 2 minutes or less, depending on the proficiency of the person taking the test.
EyeQue’s FDA-approved miniscope uses the smartphone screen to take EyeQue vision tests to estimate refractive error. According to the company, the miniscope is designed to work specifically with a smartphone.
Daniel Fletcher and his students at the Bakar Fellows Program at Berkeley Research at the University of California are developing a handheld ophthalmoscope. Fletcher and his students are teaming up with clinicians to detect retinal diseases caused by diabetes using the RetinaScope.
“The advanced technology built into cell phones is allowing us to scale down what would normally be much larger medical devices,” Fletcher, a professor of bioengineering, told the research center’s magazine in April. “The key is the phone, which we modify with hardware and software to make it a tool for physicians and eventually consumers.”
RetinaScope is designed to allow a primary care physician to differentiate a healthy retina from one with early stages of retinal disease caused by diabetes. Fletcher told the magazine that clinical test results from pilot studies demonstrate the reliability of RetinaScope.
There is still much unknown about retinal diseases, but the hope is that new software programs and technologies will allow patients to conduct not just more frequent testing from the convenience of their homes, but more accurate testing. And that could lead to a better understanding of retinal diseases and better treatments for patients. RP