New research published in Translational Vision Science & Technology explored the impact and effectiveness of Neurolens (by Neurolens, Inc.) in patients experiencing headaches caused by potential vision-related issues.
Give me some background first.
An estimated 52% of the global population is said to experience headaches, with a decrease in productivity and quality of life (QoL) as just a couple of common resulting (and detrimental) impacts.
A major cause for this: vision-related conditions.
I’m listening …
The reason: Today’s society spends an estimated 8 to 12 hours per day in front of some form of digital technology; in fact, a recent study commissioned by CooperVision identified over 50% of U.S. individuals spend 6+ hours on their digital devices.
Even further: A 2024 survey conducted by the American Optometric Association (AOA) found that nearly 70% of the American workforce spends 7+ hours a day in front of digital screens.
And the result of this?
A number of vision issues may arise from this increased visual demand, including digital eye strain (DES) or computer vision syndrome (CVS), which could also lead to:
- Migraines
- Neck or back pain
- Ocular health complications
- Myopia
- Dry eyes
- Blurred vision
- Exacerbation of other undiagnosed eye conditions
- Further effects on sleep quality and mental health
Additionally, researchers have noted uncorrected refractive error and binocular vision abnormalities as two of the major causes behind such vision-related headaches.
So how can these be treated?
While refractive errors are typically easier to manage via corrective spectacles or contact lenses, the study authors noted that “binocular vision problems are more difficult to address given the complexity in accurately identifying and clinically diagnosing individuals who could benefit from an intervention.”
One option includes Neurolens technology.
What is this?
The Neurolens system—developed by the same-name company, which was established in 2012—consists of a novel device and lens technology designed to “objectively detect and correct eye misalignment with [prescription-based] contoured prism lenses.”
The intent: by correcting eye misalignment, patients can be relieved of vision-related issues (such as those listed above).
This is done via three steps using the following:
- Symptom screener
- (ie: a lifestyle index; Likert scale-type questionnaire with seven symptom questions)
- Neurolens measurement device
- Novel contoured prism technology
- Applied to patients’ prescription lenses
How does the device work?
The measurement device, commercially available in the U.S., examines eye misalignment at two points (distance and near) and takes three measurements:
- Pupillary distance measurement
- Dissociated phoria test
- Associated phoria (eye alignment) test
Based on these, the device calculates a prescribing guideline (dubbed the “Neurolens value”) via a proprietary algorithm, which is then used to prescribe the Neurolens contoured prism lenses.
Now talk about this study.
Researchers sought to assess the impact of Neurolens on patients with headaches by using a six-question Headache Impact Test (HIT-6) questionnaire.
A total of 300 participants (aged 18-60) were enrolled, of which 195 were randomized into this dual-arm, double-masked crossover study (NCT05070767), conducted across 10 clinical sites:
- Neurolens group: Neurolens spectacle lens
- n = 112
- Control lens group: simple refractive error correction spectacle lens
- Shamir Autograph II single vision or progressive-addition lenses with Crizal Rock treatment
- n = 83
- Shamir Autograph II single vision or progressive-addition lenses with Crizal Rock treatment
Participants in both groups wore both lenses for 30 ± 10 days each, separated by four clinic visits, with each group starting with the opposite lens before crossing over to the other.
Anything else?
Two subgroups with reduced near point of convergence (NPC; > 5 cm) were also established following visit 1,
- Group 1: presbyopes / young adults
- Group 2: presbyopes / older adults with additional near-vision correction needs
And what was measured?
All participants were evaluated in their responses to the HIT-6 questionnaire; the primary outcome was the mean difference between patients’ HIT-6 scores between both groups.
Secondary outcome included the mean difference between the change in scoring among the two subgroups with reduced NPC.
Findings?
First: A total of 88% of the initial participant number completed the study (170/195).
Second: In all, a greater improvement in HIT score was noted in the Neurolens group vs the control lens group (with a mean difference of −1.53 points; 95% confidence interval [CI], −2.8 to −0.26; p = 0.01).
And in the subgroups?
The authors noted a greater improvement in HIT score with Neurolens; however, the improvement was not statistically significant (mean difference = -1.89 points; 95% CI, −4.27 to −0.47; p= 0.11).
Any adverse events?
Two participants (from each group) experienced “anticipated” adverse events (AEs), where they were not able to adapt to or wear their respective lenses.
Expert input?
Based on the findings, the investigators noted that the study warrants evaluation and treatment of patients with vision-related disorders who are “impacted by headaches or digital eyestrain who may not fit the existing diagnostic criterion for binocular vision issues.”
Take home.
The authors concluded that Neurolens wear “demonstrated a statistically significant improvement in the [QoL] of individuals impacted by headaches versus placebo treatment.”
Further, despite no clinical significance in the overall reduction, “a clinically meaningful improvement with Neurolens treatment cannot be ruled out with high certainty in the current study,” they stated.