Workshop’s Message: Handle Data with Care

GAITHERSBURG, MD – Digital Health devices can help detect eye disease in various health-care settings, although ophthalmic practices need to carefully monitor data they generate, and primary-care practices and patients using such technologies require extra instruction to use them safely and effectively, a panel of eye experts said here.

Ophthalmic Digital Health devices can safely be used for the screening and monitoring of patients with glaucoma and macular diseases, panelists said at the Ophthalmic Digital Health Workshop on October 23. The Food and Drug Administration, Byers Eye Institute, and several ophthalmology organizations hosted the workshop.

“What the glaucoma clinician needs day to day is to determine whether the disease is stable or progressing,” said Michael H. Goldbaum, MD, of the University of California, San Diego. “Machine learning systems are quite good at detecting progression.”

Regarding macular degeneration, Notal Vision CEO Quinton Oswald said, “We know the earlier you get a patient in the switch from dry to wet AMD, the better the outcome is going to be.” His company sells ForseeHome, a home-based device to detect this transition. The device feeds data to a cloud-based platform, and ophthalmologists and ophthalmic technicians in an independent reading facility review them. Once the change is detected, the patient’s treating physician gets an alert. On average, Oswald said, they are intervening with patients when their vision is 20/40.

Skilled Techies Needed

Ophthalmology offices that employ digital or telehealth devices need to appoint an employee skilled in information technology and software, so if something goes wrong, that person will recognize there is a problem with the data acquisition, not the data itself, said session co-moderator Ken Nischal, MD, chief of pediatric ophthalmology at the University of Pittsburgh Medical Center.

Michael Chiang, MD, of Oregon Health and Science University, agreed. “Doctors feel pushed to do more in less time,” he said, “often with fewer resources than ever before … there has to be someone available who is going to interpret that data.”

Devices used in primary-care settings, where providers may be not familiar with eye disease, should incorporate preferred practice patterns recommended by organizations such as the American Academy of Ophthalmology. These guidelines clearly state what actions such providers need to take, said Michael Abramoff, MD, PhD, of the University of Iowa.

Home-testing Litmus Test

When it comes to using devices in the home setting, Dr. Chiang said he uses the litmus test of “Could your grandmother use this system?”

“In glaucoma, we’ve got evidence that patients cannot put eye drops in their own eyes, let alone use these systems, so I don’t know how they’re going to perform when they’re asked to do home visual field testing,” said Dr. Chiang, noting he hopes the ophthalmology community can come up with a method of assessing the quality of data obtained outside the clinical environment. “The whole point is to lead to better outcomes, and save money and time for our health system. It could have unintended consequences if we bring more patients to the office because of bad test [results].”

At this point, machines should be used to assist physicians, panelists said. “My opinion is that machines can be very good at making diagnoses or analyzing data but I believe doctors make plans,” Dr. Chiang said. He said he hopes physicians will embrace machines as “decision aids” – pieces of information used to contribute to overall clinical judgment and management of the patient.

Conference co-sponsors were the American Academy of Ophthalmology, American Academy of Pediatrics, American Association for Pediatric Ophthalmology and Strabismus, American Society of Cataract and Refractive Surgery, and American Society of Retina Specialists.