The Sizzle and the Steak


Our field seems to be littered with devices that glittered but didn’t quite deliver what they promised.  One was Neurovision, which I’ve blogged about a number of times before in its many iterations.  Originally introduced for amblyopia therapy, the same device and program was then extended to any condition involving blur – from post-LASIK residual myopia to myopia control therapy to presbyopia therapy to post-cataract deluxe IOL disappointment.  amblyopia-adult-training

The theory was that cortical fine-tuning or high-level vision could compensate for abnormalities in the optical elements of the eye such as corner or lens, relatively low-level vision.  Neurovision, re-packaged as Revitalvision, staked its major claims on the fact that it was an FDA approved device.  Yet FDA approval speaks more to the safety of a drug or device, and not necessarily to its therapeutic effect or efficacy.

Riding a similar wave of neuroplasticity and FDA fanfare, NovaVision was a company that rolled out a product designed to rehabilitate visual field loss.  Note that in this instance the device is FDA cleared, a step below FDA approval.  I recall when our colleague, Don Getz, invited one of the company’s principals to meet with our Vision Help group to demonstrate the product before it was commercially sold in the U.S.  The company operated from 2003 until 2010 at which time it declared bankruptcy.

NovaVision

It is interesting to note in NovaVision’s bankruptcy announcement that the device, promoted as “Vision Restoration Therapy”, or VRT, also has indications in the treatment of age-related macular degeneration, glaucoma, diabetic retinopathy and attention deficit disorder/attention deficit hyperactivity disorder.  In late 2010 Vycor Medical, Inc. announced that it had purchased the assists of NovaVision, and the VRT product was re-launched in 2011.  In Medical Device Daily Tom Bridges, VP of Marketing for NovaVision (now a subsidiary of Vycor) was quoted as saying:  “Unlike other therapies that help patients simply compensate for, or adjust to, their vision loss, VRT can actually permanently restore visual function and, thus, has a more significant impact on a patient’s emotional and physical well-being.  While other rehabilitation modalities such as speech, physical and occupational therapy have been established as a standard of care for stroke and traumatic brain injury victims, our innovative Vision Restoration Therapy addresses a previously unmet need for vision recovery.”  In 2012 Vycor posted this promotional YouTube video:

At the end of the video, a disclaimer appears on the screen which reads as follows: “The doctors’ appearance in this video does not imply an endorsement by either the doctors themselves or their institutions.  Promotions of these real-life stories does not imply that the regaining of the ability to drive is guaranteed after treatment and there is no guarantee that a patient will benefit from this therapy, as with all therapies individual results vary.”  It is noteworthy that NovaVision’s VRT was adopted in major medical centers such as Bascom Palmer, Emory, and Johns Hopkins.

Here is an interesting point/counterpoint CME presentation on NovaVision’s VRT by two neuro-ophthalmologists, Nancy Newman and Neil Miller, circa 2006.  You can access another interesting discussion here, summarizing the controversy over whether the results of VRT are more due to improved visual attention, awareness and eye movement or scanning strategies than in restoration of actual field loss.  Sabel, who pioneered VRT offered his counterpoint  to the criticisms, and the NovaVision website chronicles its clinical studies.

More recent work by Sabel and colleagues delves even deeper into elements of visual cognition, and the effects of VRT as a form of visual cognitive rehabilitation.  This is evident in his interpretation of what he calls “sight blindness” in two companion articles in 2013, one in Frontiers in Neurology and the other in PLOS One.  Discussion about the efficacy of VRT in restoring visual field loss is sure to heat up again with Sabel’s most recent article just published in JAMA Ophthalmology.  It is a prospective, randomized, masked, and placebo-controlled study. Though I can’t reproduce the full article here, you’ll be struck by the description of VRT as “behavioral vision training”.

Vycor has adopted a clever business model in not waiting for the NovaVision controversy to resolve.  Assuming that visual attention, eye movements and scanning may play a significant role in transfer to ADLs  such as reading, orientation and mobility, and driving, it now offers a companion product NeuroEyeCoach.  Maximizing scanning strategies in hemianopia, NeuroEyeCoach taps heavily into the work by Zihl and colleagues which I blogged about in the context of rehabilitative therapy for our patient, Ruth, a couple of years ago.  I rolled these principles into a set of procedures for enhancing peripheral field awareness, a low tech NeuroEyeCoach if you will.

Neuro Eye Coach - Logo

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