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Intraocular pressure (IOP) monitoring is based on fiction. Clinicians typically measure IOP over a single visit and extrapolate the value to the patient’s overall condition and the degree of control over their IOP. “New Horizons in IOP Monitoring and Digital Health” session showcased six companies trying to turn the IOP challenge into commercial success.
By Fred Gebhart
Intraocular pressure (IOP) monitoring is based on fiction. Clinicians typically measure IOP over a single visit and extrapolate the value to the patient’s overall condition and the degree of control over their IOP.
“We know that a single IOP measurement on a single visit is not a good indication of how well IOP is controlled,” said Eydie Miller-Ellis, MD, professor of clinical ophthalmology and director of glaucoma services at Scheie Eye Institute, University of Pennsylvania, Philadelphia. “There are challenges due to corneal biomechanical changes, patient cooperation, inter-individual variation in measurement technique.”
Visual field exam results can be equally problematic. The patient’s energy level, attention span, even distracting noises can affect visual field results. How well a patient is–or is not–engaged with and informed about their disease can have dramatic results in medication adherence.
Each of those problems is an opportunity, added Dr. Miller-Ellis. She moderated “New Horizons in IOP Monitoring and Digital Health,” a showcase for six companies trying to turn opportunity into commercial success.
AcuMEMS is developing two wireless devices to be implanted in the eye to directly measure and report continuous IOP. One device is designed and implanted during cataract surgery, the other implanted during glaucoma surgery. Pressure readings are downloaded using an app on a smart phone, then forwarded to the physician.
The patient sees only whether the recorded pressure data are in or out of range. The physician gets a complete data readout and analysis.
“We have the missing piece in glaucoma–continuous IOP,” said co-founder and CEO Doug Lee. “We have the best implementation of implantable wireless technology and we have coupled our technology with existing surgical procedures to provide strong alignment with the physician and with reimbursement.”
Animal trials have been highly successful, Lee added. First in-human trials are in the planning stage.
Glaucoma patients don’t get much time with ophthalmologists. The typical ophthalmologist sees 68 patients a day and the typical patient gets 5 minutes of physician time. It’s no wonder that most patients are uncomfortable with the level of information they don’t have. And it’s no wonder that patients are woefully nonadherent to medication regimens.
“Our biggest challenge in health care is communication,” said Richard Awdeh, MD, founder and CEO of CheckedUp, a mobile health information platform. “Clinical trials show that we can engage patients, educate and engage them to improve adherence, and change their behavior as part of chronic disease management.”
CheckedUp delivers patient education, disease management, and physician messages to smart phones, tablets, and other mobile devices. Each communication can be tailored to the specific patient.
“Adoption rates are high in trials and use dramatically reduces worry for patients,” Dr. Awdeh said. “We see better medication use and better retention of information.”
Goldman tonometry has well-known problems, but it remains the gold standard in ophthalmology. Icare launched a more accurate, office-based tonometry technology in 2003 that is based on bouncing a lightweight, low-velocity probe off the cornea. A decade later, the company launched a consumer version of the technology.
“This device is economical, easy-to-use and you can train patients or their caregivers in a half-hour, maybe less,” said President and CEO John Floyd. “A memory chip stores up to 1,000 readings that the physician can download and incorporate into the care strategy.”
Home IOP monitoring fills in the missing data that surrounds isolated office readings, Floyd said. The device does not require anesthetic drops or other special preparation. The original device is approved in the United States and more than 40,000 have been sold globally. The home version has been approved in most of the world but remains an investigational device in the United States.
“No safety issues have been reported on either,” he said.
Vision screening is a weak link in vision care. Detection rates for glaucoma, age-related macular degeneration, and diabetic macular edema are below 50%, while the cost of preventable blindness has soared 130% in five years.
The problem: there is no low-cost, publically accessible screening infrastructure, said Marie Alexander, CEO of nonprofit Keep Your Sight. The organization was founded in 2011 to create a digital paradigm for open-source, online screening.
Two tests are available, Peristat for visual field function and Macustat for macular function.
“Screening costs less than $1 per patient,” Alexander explained. “This is a screening tool, not a diagnosis tool. Positive screens are sent to ophthalmologists for review and, if appropriate, the patient is advised to seek diagnosis as soon as possible. What we are trying to do is to deliver a group of high-risk, highly profitable patients because online screening has already eliminated those without vision problems and greatly reduced the false positive results that drive up the cost of diagnosis and treatment.”
Solx is developing an implantable shunt that not only reduces IOP but it monitors IOP and sends data to a base unit. The base unit automatically recharges the sensor, stores data, and uploads readings to the ophthalmologist. The only thing the patient has to do is occasionally walk within 10 meters of the base unit for less than a second.
“This shunt is wireless, remote, and automatic,” said Doug Adams, founder, president, and CEO. “The shunt itself is the antenna. The ophthalmologist can program the unit after it is implanted to read 24 times a day or 2,400 times a day or anything in between. There is no requirement for the patient to interact with the device. It is always on and always recording.”
The current version is 3 mm x 6 mm and even smaller devices are being developed, Adams said.
There are positive human data on earlier models and animal data on the current version. The entire system combines three technologies: a laser system for trabecular surgery, the shunt, and the onboard microelectromechanical systems.
Goldberg tonometry was invented in Switzerland and Swiss Microtechnology has developed what the company hopes will be the successor to Goldberg, the Pascal dynamic contour tonometer.
Pascal tonometry is far more accurate than Goldberg measurement, said Markus Dakus, product manager. It is mounted on a slit lamp and reads over 10 to 20 seconds, which can be difficult for the patient.
Newer technology is transforming the same dynamic contour tonometry into a contact lens device. A wired version, developed in 2009, could record up to two hours of continuous data. A wireless model is expected to enter testing this year.
“We hope to launch the product in 2016,” Dakus said, “We expect to sell about 25,000 units per year. This is the only technology that has been shown to measure 24-hour IOP accurately.”