Controversy is nothing new to eyecare. Lively debate can be healthy. In fact, there’s an annual meeting now in its 15th year designed specifically to court controversy in Ophthalmology.
ODs on Facebook is a private online group which now has close to 50,000 members, so when Dr. Jeffrey Cooper shared his thoughts a few days ago on a newly published study about Neurolens, no doubt it raised a few eyebrows. While the applicability of Neurolens isn’t likely to be a topic at the Annual Congress of Controversies in Ophthalmology any time soon, it will be interesting to see if the points that that Dr. Cooper raised engender any further discussion.
To contextualize this for you, the study that Dr. Cooper addresses was published last month in the ARVO journal Translational Vision Science & Technology. It is titled: Impact of Neurolens Use on the Quality of Life in Individuals With Headaches: A Randomized Double-Masked, Cross-Over Clinical Trial.
Here is the conclusion of the study as stated in the authors’ terms:
“Headaches and eye strain are significant concerns in the current digital world. The Neurolens process, an objective measurement technique coupled with the contoured lens design demonstrated a statistically significant improvement in the quality of life of individuals impacted by headaches versus a placebo treatment in this double-masked cross-over study. Although the overall magnitude of the reduction was not clinically significant, a clinically meaningful improvement with Neurolens treatment cannot be ruled out with high certainty in the current study. The study also warrants evaluation and treatment of vision-related disorders in patients significantly impacted by headaches or digital eyestrain who may not fit the existing diagnostic criterion for binocular vision issues.”
The last sentence is an interesting statement, and one with which I agree. There are significant numbers of patients who don’t fit neatly into existing diagnostic criteria for various case types of binocular dysfunction. Some of them will benefit from a small prism prescription, as I’ve detailed in The Art of Prescribing Low Amounts of Prism, Part 1 and Part 2. The sentence prior to that notes that the overall magnitude of the reduction in headaches (and the improvement in quality of life) in the study was not clinically significant. This must not have been easy for the authors to conclude, given that the corresponding author is Senior Director of Clinical Affairs for Neurolens, and the co-authors are involved with practices that promote the clinical significance of Neurolens benefits in line with the company’s website.
Dr. Cooper makes the point that the way the Neurolens device measures and derives prism is self-limiting. It is therefore not surprising that the outcome of the new study is lukewarm. Dr. Cam McCrodan addressed some of the limitations of the Neurolens model in this caveat emptor video presentation last year.
It should be noted that Neurolens is a prism lens which adds a fixed amount of 0.375^ “contoured” base-in to whatever prism is in the lens for distance. That means that if there is zero prism at distance, the patient will receive 0.75^ BI (binocularly) at near. If there is BI^ at distance, the contoured prism provides a small additional amount of BI^ at near, and if there is BO^ at distance, the contoured prism reduces that by a small amount at near.
Imagine if the first company to roll out a progressive lens for presbyopia introduced only one “contoured add power” of +0.75D. Imagine further that the clinician could only prescribe these lenses based on a proprietary algorithm through a proprietary device, and obtain the lens only from one specific lab. That would be a tough sell for most clinicians who know enough about presbyopia to predict that one progressive add power would not come close to addressing the full range of needs.
Speaking of added plus lens power at near, the result of the new study indicating that “the overall magnitude of the reduction was not clinically significant” was almost predictable based on the lack of factoring accommodation into the study. Although Dr. Cooper makes the point about the superiority of office based vision therapy for CI in line with the CITT, one could also make the argument that a significant number of patients who experience eye strain might benefit by low plus power at near with or without prism. Nor have we taken into consideration the role of low amounts of vertical prism or yoked prism.
Lastly, the challenge for future studies will not be just to establish that Neurolens is better than a placebo at near. Studies to date showing non-superiority of BI^ to placebo have been limited to the derivation of prism power based on Sheard’s criterion. That typically results in considerably higher prism powers than the microprism values clinicians successfully prescribe. The challenge will be to show that a contoured prism of 0.375^ BI per lens is superior to a standard prism of 0.50^ BI per lens, as derived by tests such as fixation disparity measurements widely available.
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Len,
This is different. Gary, because of the “microprism” concept. My clinical experience has been that the high majority of prism in low amounts is absorbed well at distance, even though its utility is typically greater at near. Neurolens and other microprism approaches aren’t usually targeting geriatric patients.
Good point, Gary. Sometimes it serves the patient better if we try to be less “heroic”.
Well controversy or not, the Neurolens helps some of my primary eye care patients.
The process in the primary care setting of testing for the Neurolens Value (NLV), visual symptom (Lifestyle) level and demonstration of the Neurolens Value (“Present and test for Performance”: visual acuity, stereoacuity, fixation disparity, comfort, etc) educates the patient that they see one world through two eyes and binocular vision at times needs help.
For patient with visual symptoms related to the use of their eyes (e.g., LRVP, concussion symptoms, etc), Neurolens is another solution for the patient to consider in the list of treatment options (that is, informed consent of treatment options):
– Best optical distance prescription (best done with binocular refraction)
– Neuro-Optics: added plus at near, added minus, vertical prism, yoked prism, horizontal prism (BO for distance eso, BI for near-tasks), tints, Syntonics and Neurolens
– Occlusion (for improved visual acuity and inverse occlusion to boost binocularity and reduce suppression)
– Active Vision Therapy
– Maintenance Therapy
These sequential management considerations are usually not linear, not stand alone treatments, may be concurrent or deferred (by the patient) to be more strongly considered later.
Neurolens raises the bar for primary eye care patient education that their visual symptoms may be significant (other OD’s may have not asked, could not address or dismissed ) yet with solutions to be considered (or deferred).
Ron
Thanks for commenting, Ron. Jeff Cooper’s point is that Neurolens is perceived, by the company as well as many providers at the primary care level who are promoting it, as being a panacea for binocular vision problems. By what you wrote, it’s clear that you recognize it is one potential tool, but just one tool among many and not necessarily a superior one. When one adopts that approach, there really isn’t much controversy.
The lens has advantages. It is well marketed and thus believable to patient and doctor. It is costly, thus again making it more believable much as Johnny Walker black label is more believable than its red label.
Vision rides on Emotion. Without Emotion we would be largely blind because we see what attracts or repels us. However it may effect physiology, the Neurolens is commercially designed to handle the emotional end of seeing.
We can, of course, use our favorite theories to counter any placebo effect with a nocebo effect to help keep patients from getting better and clogging the Internet with testimonials.
Medicine, with their position statements, do it all the time.
Any microprism Rx has to counteract misperceptions. I’ve heard from patients that they’ve been told anything ranging from “Prism is just a bandaid” to “Prism is a crutch don’t do it” to “It probably won’t work, but there’s no harm in trying it”. So no shortage of neutrocebo to nocebo effects out there. The key for Neurolens is to show that “contour (micro)prism” of 0.375^ BI per lens is superior to a standard (micro)prism of 0.50^ BI. I look forward to that study being conducted one day.