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By Fred Gebhart
Say good-bye to periodic testing and say hello to data streams–BIG Data streams. From glaucoma testing to diagnostics, treatment monitoring, practitioner and practice benchmarking and clinical research, masses of data are changing the face of glaucoma care.
Panel members address questions about big data during the New Horizons in IOP Monitoring, Diagnostics, and Digital Health session
“The future is one in which we will be reacting to streams of data,” said Robert Weinreb, MD, chairman and distinguished professor of ophthalmology and director of the Shiley Eye Center at the University of California, San Diego. Dr. Weinreb moderated a session on “New Horizons in IOP Monitoring, Diagnostics and Digital Health.”
“The first place we will see this change is with our approach to IOP and continuous monitoring,” he said. “Over the next five years, I see the paradigm changing. New devices and new data will improve our understanding of the disease.”
Start with diagnosis. Glaucoma is a major cause of irreversible blindness worldwide. People lose their vision because they don’t get treated, said George Spaeth, MD, Esposito Research Professor at Wills Eye Hospital/Thomas Jefferson University, Philadelphia. They don’t get treated because they don’t get diagnosed.
“In some parts of the world, 80% of people with glaucoma never get diagnosed,” Dr. Spaeth said. “We can address that diagnosis gap using contrast sensitivity testing.”
Wills researchers have developed an automated contrast sensitivity test, SPARCS, that evaluates visual resolution and acuity, motion perception, on-off changes, and defects in the visual field. The five-minute test is based on contrast gratings in five areas of the visual field, using a standard computer monitor to score contrast sensitivity to assess and localize vision loss.
SPARCS can distinguish glaucoma, macular degeneration, diabetic retinopathy, and cataract from vision. The goal, Dr. Spaeth said, is to put SPARCS online for self-administration and referral for clinical evaluation as needed.
Continuous monitoring is also how ophthalmologists and ophthalmologic practices will be guided and assessed. IRIS, the data registry established by the American Academy of Ophthalmology (AAO), has already recorded more than 20 million patient visits, representing more than 7 million unique patients since the official launch in 2014.
“We anticipate the numbers are going to rise substantially to over 100 million patient visits within the next couple of years,” said AAO’s CEO David Park II, MD. “That is big data. And in today’s world, data is the key currency to demonstrate patient outcomes, navigate payer systems, ease maintenance of certification and license renewal, benchmark and improve your performance, and conduct clinical research.”
Individual practitioners and practices can already use IRIS to benchmark their own performance and guide improvements. Experience in cardiology and other specialties have shown that registries are rich resources for clinical research.
“IRIS is a game changer for innovation,” Dr. Park said. “We are trying to reduce undesirable variation in practice and improve the outcomes of care.”
Once glaucoma has been identified, IOP monitoring is the next step. The current standard of care, measuring IOP at office visits, is far from ideal.
“What if the real IOP is lower and we are measuring peaks of pressure?” Dr. Weinreb asked. “Or what if we are measuring troughs and the actual pressure is much higher? Continuous IOP monitoring would give us better information for making clinical decisions.”
Two approaches to continuous IOP monitoring are being developed, temporary external sensors and permanent implantable sensors.
Implandata Ophthalmic Products’ implantable sensor directly measures IOP, but the device has not yet been approved for marketing. A pilot study in patients undergoing cataract surgery showed no narrowing of the anterior chamber and no device-related severe adverse events, but the size of the implant caused pupil distortion and other problems. A smaller iteration appears to have addressed the issues, said CEO Max Ostermeier, MD, and more detailed data will be discussed at the World Glaucoma Congress 2015 in June.
“This device allows you to take IOP readings anytime,” added Dr. Ostermeier. “It allows the physician to monitor the patient long term, and it allows the patient to monitor their own IOP, which empowers and involves them in treatment. Long-term, continuous monitoring is the way treatment will be guided and assessed.”
Sensimed has a CE-marked device, Triggerfish, which uses a contact lens sensor to measure changes in ocular volume.
“We see 24-hour IOP monitoring as a continuum of care,” said Sensimed CEO David Bailey. “The contact lens solution is minimally invasive screening and treatment management tool that is applicable to a very broad population. The implant is a targeted solution for a select population. The two together will benefit the entire spectrum of glaucoma treatment.”
Triggerfish uses a circular strain gauge to measure dimensional changes in the eye. Changes are transmitted wirelessly to a receiver that can be fitted to the face for sleeping or into eyeglasses for daytime use.
There is a strong correlation between changes in ocular volume and IOP, but the correlation has not yet been mapped, Bailey said. The company is using a data-registry, user groups and an advisory board to better define the clinical utility of ocular volume changes.