Linda A. Lam MD MBA

Vice Chair, Satellite Clinical Affairs

Associate Professor of Ophthalmology

USC Keck School of Medicine

Los Angeles, California

2019

Digital Health &

Ophthalmology Spotlight

Disclosure

Ocutrx- consultant

Demographics

By 2030, over 72 million in United States will be 65 or older

The aging of the population brings with it a rise in chronic

ocular conditions such as

Age-related macular degeneration

Glaucoma

Diabetic retinopathy

Aging demographics and cost

Associated burdens of

frequent office visits + regular monitoring + ongoing treatment

= burgeoning health care costs

Technology advancements could help meet the challenge of

controlling costs - particularly in ophthalmology

Digital advances in ophthalmology are aimed at improving

diagnosis and treatment

Digital Health

Digital health - convergence of digital technologies with

health, healthcare, living, and society to enhance efficiency of

healthcare delivery and to be more personalized and precise

Digital health platform-

aim to improve health management fo patients and providers

Digital health provides the chance to facilitate personalized

medicine at lower cost

How Are Digital Health Products Used?

Providers and other stakeholders are using digital health

technologies in their efforts to:

• Reduce inefficiencies

• Improve access

• Reduce costs

• Increase quality

Make medicine more personalized for patients

FDA and Digital Health

• Ophthalmic digital health technology per FDA panel defined

to encompass (10/23/17)

• Software as a medical device

• Hardware devices with embedded software as a

principal component (software in a medical device)

• Diagnostic or decision support AI or other health data

analytics

• Ophthalmic telemedicine platforms

• FDA does not regulate the practice of telemedicine;

however, it does regulate ophthalmic cameras and other

devices that enable telemedicine

FDA and Digital Health

The broad scope of digital health includes categories such as

- Mobile health (mHealth)

- Health information technology (IT)

- Wearable devices

- Telehealth and telemedicine

- Artificial Intelligence

- Personalized medicine

Digital Health & Ophthalmology

• Digital health pubmed search 14,688 articles as of 10/5/19

• Annual Growth Rate for mobile health market 29%

• 77% Americans, 52% global population with smartphones

Smartphone devicesRemote Screening for Vision Loss

Peek Vision• Peek Acuity used to screen over

80,000 children and adults

• Peek Retina clip-on smartphone

adapter for retina images

Remote Retina Capture

D-Eye Portable Microscope• Image capture without slit lamp

ophthalmoscope or dilating drop

Peek Retina

D-Eye

VR Wearables- Virtual Reality

• Magnification

• OCR (text-to-

speech)

• Facial recognition

• Bar/QR/UPC

code readers

esightODG

Jordy OrcamIrisvision

Wearable Devices –

Augmented Reality

• Oculenz AR for AMD patients

with central vision loss• Eye tracking, customized

• Moves area of vision missing in

scotoma to adjacent retina

• ORlenz AR for surgery• <200 grams

• Wireless

• Beyeonics Clarity-• AR cataract, retina sx

• 1.5 lbs

• Tethered

Oculenz

Beyeonics

ORlenz

Software identifies patient’s non sighted area (circle) and buffers the streaming video

Pixels in circle are moved into adjacent areas of retina that can still see

Video from 4K cameras

Digital map of patient’s impairment stored in processor

The buffered video

creates a hybrid image

which is projected on

device and the brain

interprets as functional

vision

OculenzTM for AMD

OculenzTM Customization and key features-Resolution correlation, scotoma monitoring, SLAM

Resolution correlation

- Diagnostics mode

allows customized

pixel manipulation

- Enables resolution to

match changes for

advancing disease

stages

Scotoma monitoring

- Automatically alert

Physician when

patient’s scotoma has

changed

- May signal that patient

may potentially need

medical treatment

SLAM (simultaneous

localization and mapping)

- SLAM based object

identification software

to audibly alert a

wearer of obstacles

such as furniture,

doors, stairs, or curbs

- 7M objects database

Caution!

Step at

3 feet to

your

left…ALERT!

Telemedicine

Scottish EyeCare Integration Project

• Goals: expedite sight-saving tx & reduce global dz burden

• Use of EMR, digital imaging, redesigned care model

• Optometry referral to NHS email with digital imaging via VPN

• Benefits:

• Reduced wait times and triage

• Improved e-diagnosis in 20% without need for visit

• Rapid response to referrers

• Scotland 75% all referrals electronic from community to hospital

Implications for chronic disease: glaucoma, DR, ROP

Jeganathan VS, Hall HN, Sanders R. Electronic Referrals and Digital Imaging Systems in Ophthalmology: A Global Perspective. Asia Pac J Ophthalmol (Phila).

2017 Jan-Feb;6(1):3-7. doi: 10.22608/APO.2016110.

TelemedicineCloud-based referral in NHS

• 10 yr strategy to telemedicine to reduce unnecessary referrals

• Web-based pt review initially in referral path:

• 52% did not need specialist referral

• 14% needed urgent referral

• Post implementation >50% referrals avoided

Artificial Intelligence in DR

AI in Diabetic RetinopathyOver 50% of patients with DM do not get an annual eye exam

• IDx: 1st AI diagnostic system with FDA clearance 4/18

• AI-powered, cloud-based system for use by PCP

• AI system achieved

• 87% sensitivity

• 90% specificity

• 96% imageability rate

• Under same tested standard

for sensitivity, for instance,

ophthalmologists perform

between 33-73%

Abràmoff MD, Lavin PT, Birch M, Shah N, Folk JC. Pivotal trial of an autonomous AI based diagnostic system for detection of

diabetic retinopathy in primary care offices. NPJ Digit Med. 2018; 1: 39.

Digital Healthcare & Big Data

• Connectivity of digital systems can feed into vast

databases, allowing for study of outcomes

• Outcomes study can generate AI platforms

• Potential to provide important information for physicians and

pharmaceutical researchers

•

Challenges for Digital HealthRegulatory and safety issues-

• Meet medical device standards regarding unmodified consumer hardware

platforms, e.g. smartphones and tablets, related to safety, interoperability,

and wireless coexistence

• Smartphone light source used as ophthalmic device illumination, FDA

regulatory issues such as optical radiation safety testing are considered

Compliance issues:

• HIPPA, data security, and encryption important when commercial digital

devices are adapted for medical purposes

Configuration safety and user interface design concerns:

• Software/hardwear changes can radically change user experience and may

have significant implications, especially if the intended users are patients

Summary:

Digital Health & Ophthalmology

• Digital health technology has the potential to augment

Telemedicine

Personalized health data collection

Home health care

Disease monitoring

Aiding with screening, diagnosis, and treatment

Digital health revolution provides a compelling

value proposition to all stakeholders in the

health care marketplace:

patients, physicians, payers, and pharma

to meet challenges of rising costs associated with

changing demographics

Thank You

linda.lam@med.usc.edu