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Implantable sensor enables remote IOP monitoring, management
Measurements are sent to a cloud-based database, and a smartphone app displays IOP history and reminds patients to use glaucoma medications.
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An implantable IOP measurement device provides constant IOP monitoring in pseudophakic patients with glaucoma, according to a surgeon involved in its development.
The Eyemate (Implandata Ophthalmic Products) is expected to be commercially available in Europe in late 2016 or early 2017, according to H. Burkhard Dick, MD, PhD, OSN Europe Edition Board Member and an investigator in a clinical trial of the device.
“The Eyemate system delivers direct and real IOP as the sensor sits right inside the eye, provides a real circadian IOP profile and enables IOP measurement between office visits,” Dick told Ocular Surgery News. “The system allows remote disease management, promising a reduced number of office visits.”
Elevated or fluctuating IOP is detected early, and therapy can be initiated or adjusted accordingly at the physician’s discretion.
The device has been well tolerated, with no sight-threatening complications in a clinical trial, Dick said.
Design and function
The Eyemate-IO intraocular version is designed for ciliary sulcus placement during cataract surgery. The Eyemate-EO extraocular version is designed for suprachoroidal placement during non-penetrating glaucoma surgery. Both versions are injected into the eye.
Both versions of the Eyemate feature an application specific integrated circuit sensor chip that measures IOP. The Eyemate is controlled and powered with a hand-held device that is also used to store and read measurements, Dick said. Measured data are sent via that hand-held device to a cloud-based database that the physician can access remotely.
“Patients can take IOP readings with ease by themselves under normal life conditions, and diurnal and nocturnal IOP can be captured by automated continuous IOP measurement over 24 hours, comparable to Holter monitoring,” he said.
In addition, a smartphone app displays IOP history, gives the patient insight on the impact of medication use and adherence, and reminds the patient to use medication.
“It is important to note that the product design follows the concept that therapeutic decisions due to Eyemate data are only made by eye doctors. The system is not designed so that patients make therapy adjustments by themselves,” Dick said.
Monitoring and adherence
The Eyemate gives patients critical information on disease status and encourages them to adhere to medication protocols, Dick said.
“Eyemate will also answer many still unanswered questions in glaucoma in regard to what’s causing disease progression and what therapies work best for which patients, a big data aspect,” he said.
The ARGOS-02 study has collected more than 30,000 data points through patient self-measurements. In a standard care setting with Goldmann applanation tonometry measurements taken every 3 months, the same number of patients would have produced less than 100 IOP data points in that same time frame.
“So much better IOP data quantity and quality provide actionable and crucial information for improved disease management,” Dick said. “Patient questionnaires in the current study reveal that self-monitoring educates patients on the importance of therapy adherence and showing better compliance to medication. So, overall it can be expected that the majority of glaucoma patients who show disease awareness and are concerned [about visual impairment] will be supported by better disease status information, enabling better therapy adherence.”
Limitations of the device include the need for a larger incision than what is typically used in standard cataract surgery and challenges encountered with narrow pupils, Dick said.
“Design optimization has been started to allow usual incision sizes and easy implantation also in challenging eyes, allowing broad adoption of the product,” he said.
Cost and reimbursement
The device is expected to be commercially available by early 2017, initially for primary implantation in patients with primary open-angle glaucoma undergoing cataract surgery. Later in 2017, it is expected to be available to patients undergoing corneal transplantation, Dick said.
Pricing of the device is expected to be similar to that of premium IOLs, he said.
Existing public health reimbursement for keratoplasty would cover the Eyemate.
“For other indications, out-of-pocket pay and reimbursement by private insurance will be the initial way of cost covering,” Dick said.
Discussions of provisional reimbursement codes are ongoing.
“Ultimately, full coverage by the public health system will be achieved, rather by providing a service to the eye doctors and patients, not so much by covering the products (implant/hand-held device) that are required to enable this service,” Dick said. – by Michela Cimberle and Matt Hasson
- For more information:
- H. Burkhard Dick, MD, PhD, can be reached at University Eye Clinic, University of Bochum, In Der Schornau 23-25, 44892 Bochum, Germany; email: burkhard.dick@kk-bochum.de.
Disclosure: Dick receives research funding and reimbursement from Implandata Ophthalmic Products.