The American Academy of Ophthalmology (AAO) has included electroretinography (ERG) in its 2024 update of Preferred Practice Pattern Guidelines (PPP)—referred to as the “gold standard for clinical decision-making”—for diabetic retinopathy (DR).
LKC Technologies, developer of the first (and only) FDA-cleared, portable, handheld device for ERG testing, announced the news earlier this week.
First, let’s talk about ERG.
What it is: A noninvasive and objective test that measures electrical activity of the retina in response to a light stimulus to evaluate the function of photoreceptor cells, inner retina cells, and ganglion cells.
Why it’s important: An ERG is key for early detection of retinal dysfunction.
- See here for a deeper dive into this.
Now to these guidelines.
The AAO’s PPP guidelines are evidence-based statements developed by a panel of ophthalmic experts (among others ), based on “the best available” scientific data, and intended to provide guidance for clinicians in providing optimal patient care.
Their purpose: Extends to identifying characteristics and components of quality eyecare and delivering recommendations for care in an easy-to-use format.
- To note: PPPs are reviewed on an annual basis and valid for 5 years from their issue date (unless a revision is made).
- See here for a look at the latest published PPPs, published online in the AAO’s Ophthalmology journal.
And in the context of DR?
Published last month, the Diabetic Retinopathy PPP 2024 was written by members of the AAO’s Retina/Vitreous PPP Committee and reviewed by various patient-centered organizations (such as the American Foundation for the Blind, Foundation Fighting Blindness, and Lighthouse Guild).
- See the guidelines in their entirety, including an introduction to diabetes and DR as well as the diagnosis and management protocol.
So how does ERG come into play?
“As diagnosticians and treating physicians, we need an objective functional complement to structural imaging,” stated Sruthi Arepalli, MD, an assistant professor of Ophthalmology at Emory University School of Medicine specializing in vitreoretinal surgery and uveitis.
Dr. Arepalli added that ERG provides this complement by detecting functions that may precede visible structural changes. “This allows for earlier intervention and more personalized patient care.”
But then why hasn’t it been used more routinely in clinical practice?
One reason given by experts: Early-generation ERG devices weren’t considered practical.
While ERG has long been clinically studied and used in research/academic settings, its adoption in everyday clinical practice has been far from the norm.
- And this is where LKC Technologies’ gamechanger-of-a-device comes into play—enter in: RETeval.
Give me the rundown on this.
Granted FDA 510(k) clearance in 2015, the RETeval is a handheld ERG/visual evoked potentials (VEP) device that enables clinicians to detect functional stress in the retina and optic nerve pathways and provides objective information.
Its key capabilities include earlier detection, prediction, follow up, and monitoring of retina and optic nerve diseases.
- Along with DR (and other ischemic conditions), its target diseases include glaucoma and optic nerve neuropathies, as well as pediatric diseases and suspected inherited retinal diseases (IRDs).
How does it work for DR?
Compatible with Mac and Windows systems, the device uses LKC’s FDA-cleared, noninvasive LKC-patented sensor strip skin electrodes to prevent corneal contact.
Check out the 2.3-minute, three-step process, and see below for a visual of it in action.
The DR Assessment Protocol is used to predict the risk for disease progression, with a score of 23.4+, translating to an 11-fold risk of a patient requiring intervention within 3 years.
- And its CPT code: 92273
And the types of tests it performs?
The RETeval uses ERG to evaluate retinal function, with the DR Assessment and Photopic Negative Response (PhNR) test taking an estimated 1 minute to 1 minute, 15 seconds, and the Flicker 16 taking around 20 seconds.
A couple of notes:
- Flicker refers to the frequency of light flashes used in an ERG test, with Flicker 16 a specific protocol that uses different frequencies to assess retinal function.
- PhNR is a specific wave component of the ERG waveform that reflects retinal ganglion cell activity.
The advantages of this testing: The retinal function can be “reliably monitored” over time and retinal treatments are evaluated for their efficacy in human care, veterinary practices, and medical research.
Go on …
Included in the DR Assessment protocol report following each test—which can be exported to a clinician’s electronic health record (EHR) or electronic medical record (EMR) system—is the following data:
- Age-adjusted reference data
- Final DR score
- Bi-polar functional stress versus reference data
- Pupil response versus reference data
Has this device undergone clinical testing?
But of course. With a reported 200+ research publications citing the RETeval, check out a few examples of the supporting data on it for DR here, here, and here.
Lastly, how can I add it to my practice?
Request a demo here.