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Ophthalmic digital health techniques meet public health needs
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Digital health is a rapidly growing field in ophthalmology, and new technologies can better treat, manage and monitor progression of ophthalmic diseases.
Ophthalmic digital health has great potential to address unmet public health needs for patients with ocular conditions, according to Malvina Eydelman, MD, director of the Division of Ophthalmic and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health.
Ophthalmic digital health is providing a better understanding of the progression of ocular diseases such as glaucoma or age-related macular degeneration. At the FDA’s Ophthalmic Digital Health Public Workshop in Washington in October 2017, presentations reflected the potential for digital health devices on mobile platforms, she said.
“Digital health devices are monitoring patients’ ocular conditions in real time, often through mobile apps on patients’ smartphones or tablets. This real-time monitoring allows up-to-date ocular condition information for the clinician and is less burdensome for the patient who may not have to go to a clinic as often to assure proper monitoring of their condition,” Eydelman said.
Source: Pravin U. Dugel, MD
Growing market
The U.S. mobile health care market is expected to grow sixfold between 2015 and 2020, according to data presented at the workshop. So far, the FDA has cleared more than 100 mobile health apps for medical use.
Smartphones are a logical step into ophthalmic digital health care, as health apps are becoming a part of everyday living, Ken K. Nischal, MD, FRCOphth, of the Children’s Hospital of Pittsburgh, said.
Nischal discussed the safety and efficacy of ophthalmic digital devices with a panel of colleagues at the FDA workshop.
“Digital health care really is a response to the increased connectivity we’ve gotten from the evolution of the smartphone. Until the iPhone came along, none of what we are talking about would have been possible,” Nischal said.
However, the relevance of digital health technology and apps designed for smartphones depends heavily on big data evidence. There are health apps available right now for patients that have not been tested on “tens of thousands of individuals,” he said, and therefore their effectiveness has yet to be proven.
“The relevance of clinical utility requires large data analysis, and in my opinion, that must be an important point,” he said.
New roles needed
With so much data coming into the field through these digital routes, Nischal said that specific roles within the health care environment will have to change. To properly understand and evaluate the data, personnel will not only need a medical background, but also preferably an IT background to be able to understand the data.
For example, if data coming from an app is due to a software glitch, an employee with an IT background may be able to recognize what is happening, whereas an employee with just a medical background may not, he said.
“If they don’t recognize that the data they’re reading is artifactual, they could make incorrect diagnoses,” he said.
The data collected through devices and smartphone apps will have a tremendous impact on the field of ophthalmology, Nischal said. Through his work with a project in India, more than 1 million data points of refractive error have been collected in patients between the ages of 5 and 7 years.
It is possible that over the next 5 years, he said, his group could look at those data points and correlate them with nutrition, sunlight exposure or any other number of behavioral factors, and possibly develop an algorithm to help patients modify their behavior to change health outcomes.
“Say we develop an algorithm saying that if you have a refractive error at this age and this is your diet, this is what you can expect later in life. Then you can begin to see how the end user can use this data to modify their behavior and therefore change health outcomes. That’s one possible set of applications we could see within 5 years,” he said.
Innovation affecting ophthalmology
Innovation could also come with new methods of monitoring patients after surgery. For example, an ophthalmologist could feasibly put a contact lens with an IOP-monitoring coil into a patient after glaucoma surgery to give a continuous live IOP feed, Nischal said.
“If the IOP suddenly drops below a certain number, an alarm goes off on the patient’s phone and they go straight to the clinic. That’s not beyond the realm of feasibility. Putting a band on the contact lens may cost another, what, $5? Monitoring a patient is going to become much better,” he said.
Presently, smartphones and telemedicine are successfully monitoring ocular conditions and saving time and money for both patients and ophthalmologists, OSN Retina/Vitreous Board Member Pravin U. Dugel, MD, said.
Dugel helped study an iPhone app called Paxos Checkup with DigiSight Technologies, a HIPAA-compliant eye examination and care coordination tool patients can use in their own home. The product enables patients and health care teams to collaborate in real time to monitor ocular conditions, Dugel said.
Using Paxos, physicians also can capture high-resolution photos and videos that are instantly transmitted to the cloud and can be viewed instantly and remotely, he said.
“Our patients love it. Our patients love monitoring their own disease. They feel like my office has broken through the walls of their house, and they feel they have instant and constant communication with me. They feel like they’re in charge of their own disease. They feel empowered, and it’s wonderful to see. Every morning when one of my techs comes in, we open the computer and we see how many alerts there are. There may be none, there may be five. We let patients know that their vision app gave us an alert and schedule them for appointments,” Dugel said.
A 2016 study published in Indian Journal of Ophthalmology evaluated nine clinicians at L.V. Prasad Eye Institute and their ability to use the smartphone app and scope add-on to capture images of sufficient quality. The clinicians used the smartphone app on 229 consecutive patients and captured 719 useable images and 253 videos. Nearly 93% of the anterior photos and 85% of the posterior photos captured by the smartphone app were comparable to the existing clinic cameras, according to the study.
Underserved communities
Since its launch, the app has released several add-on features to enable the program to take quality anterior segment pictures of patients in remote areas where physicians and physician assistants need help diagnosing disorders, Dugel said.
The app also has an add-on device for indirect ophthalmoscopy to take high-quality posterior segment pictures of patient eyes. Physicians in India are currently conducting a study using the DigiSight app for retinopathy of prematurity screenings compared with traditional screening methods, he said.
“As part of my charity work, I went to Aravind Eye Institute in south India and saw what they needed to do for ROP screenings. It’s very difficult. You have very expensive cameras going through very terrible roads. They’re constantly making sure they don’t break down. ... They’re conducting a study using this phone app so instead of these specially made vans, these huge cameras that break down and can’t be bumped, all they have to do is carry an iPhone, and that’s it,” Dugel said.
This is a perfect example of digital health and telemedicine using innovation to monitor and diagnose conditions in out-of-clinic settings, he said.
Telemedicine in the US
Telemedicine systems are also being utilized in the United States to better serve the needs of ophthalmic patients. Wills Eye Hospital in Philadelphia has a unique software platform that allows its physicians or clinicians to use a nonmydriatic portable digital retinal camera to screen patients with patients who are at risk for diabetic retinopathy, Mary Fuska, director of telemedicine and diagnostic testing at Wills Eye Hospital, said.
“The camera we use captures fundus images of the eye. After imaging, the camera is docked to its station for images to automatically transmit to our reading center where specialists review and report on findings. Our software system creates a site for each of our partners that gives them access and management of all of their patient reports, which I think is different from anybody else out there providing this type of service. Our teleophthalmology system has no limitations on where services can be provided. It’s cloud based and compliant with all applicable federal and state laws and regulations governing the confidentiality and privacy of patient health information. Our software simply needs internet access,” she said.
The strength of the telemedicine program at Wills Eye, Fuska noted, is the quality of its ophthalmologists in house who read the images and provide specialized eye care for patients around the world.
“We manage thousands of images annually. Besides providing reporting on these images, we take the extra step and collaborate with our partners to close the loop and the gap of care to provide follow-up for telemedicine patients. There’s a considerable percentage of patients with pathology who don’t seek the care recommended. The reports may say that you, a patient, need to see an ophthalmologist to follow up with an issue in 3 months or 6 months. Many patients don’t follow through, so we work closely with our partners to ensure the patients receive the follow-up care they need. We collaborate by contacting patients to notify them of their recommended care and to any questions they have and make sure they make an appointment with their ophthalmologists,” she said.
Ophthalmology is one of the first medical fields to incorporate artificial intelligence, or deep learning, into the screening for diseases such as diabetic retinopathy, Eydelman said.
Computer-assisted diabetic retinopathy screening devices could one day be incorporated into primary care or diabetes clinics, she said.
“It is estimated that 40% to 50% of adults with diabetes in the United States do not receive yearly ophthalmic screenings as recommended, and these rates have not significantly changed over the last 10 years even with the introduction of telemedicine services. Digital health could provide ophthalmic screenings for diabetic retinopathy that would refer diabetic patients to ophthalmic health care in a timely and appropriate manner,” Eydelman said.
Safety and efficacy
The market is growing and could soon explode in terms of providing access to care with these advancements in telemedicine and digital health products, OSN Pediatrics/Strabismus Board Member R.V. Paul Chan, MD, FACS, said. However, with so many innovations coming to the ophthalmic field, it is crucial to ensure their safety and validity in the real world, he said.
“It can be complicated. The market is wide open right now. In very general terms, I think the FDA will have some mechanism to ensure safety of these apps and software involved in clinical decision-making. Ultimately, there may be a process by which people can work with the FDA just as they would for a new drug or even a new camera system. However, different rules may apply that are specific for software development and applications,” he said.
It is a growing field, but the application of these innovations and new technology will depend heavily on how well these systems are tested and shown to work by the use of clinical evidence and outcomes seen with the analysis of “big data.” Telemedicine is more than just taking a picture of the back of an eye and then someone reads it to provide a diagnosis and management plan. It takes training to be able to accurately diagnose a condition through a digital image or other testing. And using a computer-based diagnosis does not completely replace the physician, he said.
It is important to understand that many of the algorithms used for computer-based image analysis were based off of human experts making the diagnosis, so while things such as artificial intelligence and deep learning are exciting possibilities, they are not panaceas for the ophthalmic field, Chan said.
“They’re support mechanisms, and their use is synergistic with how we currently manage our patients. All of this will lead to better patient care and will also potentially make things easier for physicians and health care providers,” he said.
New rules, new problems
New rules and ways of doing things are potentially going to be needed as innovations roll into the field with digital health, Chan said. Unknown challenges are going to arise that the medical field needs to prepare for.
For instance, with so much data being collected through smartphone apps and digital health devices, the question of data ownership will be fundamental in terms of liability issues, Nischal said.
“Does the app developer own it? Does the patient own it? Is it the institution’s data? Is it the company’s data? These are questions that need to be asked right now. When you take on a digital health app on your telephone, there will be an end user agreement, and we’ll have to highlight to the user, to the public, that they must make a decision to give up the data or they hold on to the data. If they hold onto the data, the liability sits with the patient. If you give the data to the company, then the liability becomes the company’s,” he said.
Despite the questions regarding data ownership, future regulations and unknown problems, Nischal said hindering innovation during this moment would be a mistake.
“I don’t think we should stop the flurry of innovation for the sake of what are important moral, legal and ethical considerations. I think the benefit of accessibility and connectivity far outweighs those considerations. They’re important considerations, but I don’t think they should hinder development,” he said.
Regulations are a necessity, but the most exciting facet of digital health and telemedicine is what it can do for patients in need, Dugel said.
The growth of diabetes is projected to be more than 100% in countries outside of the United States and will soon be the leading cause of blindness. However, it is preventable, and what telemedicine can potentially do for patients with diabetic retinopathy is tremendous, he said.
“It’s important to have regulations in line with innovation, but with what we have right now, we can remotely be in a village in Africa and we can absolutely stop a little girl from going blind from diabetes and other disease. That’s far more important and exciting than anything else we’ve discussed,” he said. – by Robert Linnehan
- References:
- Chan RVP. Telemedicine diagnostic challenges for retinopathy of prematurity (ROP). Presented at: Ophthalmic Digital Health Workshop; Oct. 23, 2017.
- Ludwig CA, et al. Indian J Ophthalmol. 2016;doi:10.4103/0301-4738.181742.
- Panel 1: Safety and effectiveness concerns when a digital health device provides information as an aid for diagnosis and the assets, threats, and vulnerabilities to be considered and identified (Questions 1 & 4). http://www.cfom.info/meetings/OphthalmicDigitalHealth/Agenda%20_Registration.html. Presented at: Ophthalmic Digital Health Workshop; Oct. 23, 2017.
- Panel 2: Safety and effectiveness concerns for an ophthalmic digital heath device used in a clinical or non-clinical environment and the assets, threats, and vulnerabilities to be considered and identified (Questions 2 & 4). http://www.cfom.info/meetings/OphthalmicDigitalHealth/Agenda%20_Registration.html. Presented at: Ophthalmic Digital Health Workshop; Oct. 23, 2017.
- Paxos DigiSight. https://www.digisight.net/ds/product/. Accessed Jan. 15, 2018.
- For more information:
- R.V. Paul Chan, MD, FACS, can be reached at UIC Department of Ophthalmology & Visual Sciences, 1855 W. Taylor St., Room 3.138, Chicago, IL 60612; email: rvpchan@uic.edu.
- Pravin U. Dugel, MD, can be reached at Retinal Consultants of Arizona, 1101 E. Missouri Ave., Phoenix, AZ 85014; email: pdugel@gmail.com.
- Malvina Eydelman, MD, can be reached at U.S. Food & Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, 10903 New Hampshire Ave., WO66-1676, Silver Spring, MD 20993-0002; email: malvina.eydelman@fda.hhs.gov.
- Mary Fuska can be reached at Wills Eye Hospital, 840 Walnut St., Philadelphia, PA 19107; email: mfuska@willseye.org.
- Ken K. Nischal, MD, FRCOphth, can be reached at Children’s Hospital of Pittsburgh, Children’s Hospital Drive, 45th and Penn Avenue, CHP Faculty Pavilion, Suite 5000, Pittsburgh, PA 15201; email: nischalkk@upmc.edu.
Disclosures: Chan reports he is a member of the scientific advisory board for Visunex and a consultant for Alcon, Allergan and Bausch + Lomb. Dugel reports he is a consultant and shareholder of DigiSight and Banner Phoenix Eye Institute and is on the board of directors for Orbis International. Eydelman, Fuska and Nischal report no relevant financial disclosures.
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