Here they go again, published scientific nonsense.
“Neurolenses Proven to Reduce Headache Symptoms
The current report highlights the data from the recently published double-masked, randomized Headache Study . Based on the clinical study data, Neurolenses provide a statistically significant improvement in headache symptoms. A quick literature review suggests that the improvement noted in the current study is on par with several commercially available pharmacological solutions. The Neurolens process provides a simple and effective way to detect, diagnose and treat patients with digital eyestrain and headaches.*
*Efficacy & adverse events have been fully evaluated and discussed in the peer-reviewed publication.”
The following are my comments related to that publication of their study.
Labhishetty V, Cortes J, van de Pol C, et al. Impact of Neurolens Use on the Quality of Life in Individuals With Headaches: A Randomized Double-Masked, Cross-Over Clinical Trial. Transl Vis Sci Technol. Jan 2 2024;13(1):27. doi:10.1167/tvst.13.1.27
Lynn Mitchell Phd at the OSU College of Optometry and I met, at the request of the president of Neurolens to discuss the results with their “people”. She concurred with my conclussions.
Personally, I have always had trouble understanding why Neurolens would work. It defies all our current understanding of the interaction of the accommodative-vergence system whereby fixation disparity is believed to be a disparity error which drives fast vergence response. The accommodative/vergence system relies on multiple feedback systems to further reduce the load of vergence demand (ACA, CAC, proximal vergence, fast vergence and slow vergence).2-6 Lastly, over time the muscles actually change the number of sarcomeres to further reduce the load. There is ample evidence from numerous laboratories that this redundant system usually is successful in initiating a rapid accommodative/vergence response.7 To complicate the matter, neither the time performed doing near work, nor the effort expended accommodation/vergence has been put into this or other paradigms. I have always maintained that the symptomatic patient with binocular problems can be easily identified since they are usually symptomatic from testing.8 The authors of this Neurolens paper, in my opinion, incorrectly interpreted the CITT’s findings by noting that one test does not correlate with a diagnosis of symptomatic CI, but they seem to ignore that the CITT group did find that a cluster of 3 signs is significant for symptomatic CI.9 In summary, Neurolens has ignored all of these complexities and created an apparatus to objectively measure the deviation at distance and near to prescribe a prism at distance based on their proprietary algorithm and arbitrarily add .75 BI at near.
Recently, Neurolens performed and published a study to determine the effectivity of their contoured prism prescription.1 They performed a clinical trial whereby they measured primary outcome by using a 6-question questionnaire (HIT-6) to quantify headaches (HA). The HIT-6 has been used in numerous studies. A score of 36 indicated no headache, while a score of 78 indicated a severe HA. Smelt et. al. reported that you needed a minimum change of 2.6 by statistical analysis or 6.0 by ROC to have any clinical meaning.10
Eligible subjects for the Neurolens study needed a score of greater than 56 and all had normal stereopsis. Baseline information was measured, the mean findings of relevance were: distance phoria was 2 X and the near finding 5 X’; the base out fusional reserves = 15 pd which is low; and lastly the mean distance Neurolens measurement was 1.3 pd BO.
Phase 1 testing score of recruited patients = 65
Phase 2 patients are given new glasses to correct RE = 63 (regression towards the mean and correction, as expected improved the score
Phase 3 A-B reversal design half wear Neurolens and half wear control tested after 20 days of wear; then tested at around day 30; then the Neurolens patients wear the control and the control is prescribed the Neurolens for 20 days testing and testing around day 30.
Control = 61 which is a slight placebo effect
Neurolens = 58 which is not much better (but statistically significant even if not clinically significant)
“Change between the two treatment groups was 1.53 points” which is not clinically significant AND furthermore, we do not know if that differences would be maintained over time. To put this in perspective, there was a 5% improvement with Neurolens and 2% with control. Add to that, in most treatment studies the initial results wain somewhat over time.
In summary, Neurolens was not found to have been clinically effective in reducing symptoms of HAs. To date the most effective method of reducing or eliminating symptoms related to binocular problems, which include more than headaches (Convergence Insufficiency Clinical Trials - CITT) is in office vision therapy with supplemental home therapy.11 Granted the CITT studies were only done on Cis but those of us who provide in office therapy and use the CITT symptom survey see similar results with other binocular problems. Lastly, those who still ascribe to Neurolens, I ask what do they for their contact lens patients? Vision therapy changes both the reflexive nature of fast and slow vergence with a lasting effect. It works with either glasses or contact lenses. When will our professions properly identify accommodative/vergence anomalies and recommend the most appropriate treatment (evidence based) for our patients?
1. Labhishetty V, Cortes J, van de Pol C, et al. Impact of Neurolens Use on the Quality of Life in Individuals With Headaches: A Randomized Double-Masked, Cross-Over Clinical Trial. Transl Vis Sci Technol. Jan 2 2024;13(1):27. doi:10.1167/tvst.13.1.27
2. Cooper J. Clinical implications of vergence adaptation. Optom Vis Sci. Apr 1992;69(4):300-7.
3. Cooper J, Scheiman M. American Optometric Association Clinical Practice Guideline. Care of the subject with accommodative and vergence dysfunction. American Optometric Association. 2010: .
4. Schor CM. Analysis of tonic and accommodative vergence disorders of binocular vision. American journal of optometry and physiological optics. Jan 1983;60(1):1-14.
5. Alvarez TL, Scheiman M, Santos EM, et al. Clinical and Functional Imaging Changes Induced from Vision Therapy in Patients with Convergence Insufficiency. Annual International Conference of the IEEE Engineering in Medicine and Biology Society IEEE Engineering in Medicine and Biology Society Annual International Conference. Jul 2019;2019:104-109. doi:10.1109/EMBC.2019.8857163
6. Scheiman M, Talasan H, Alvarez TL. Objective Assessment of Disparity Vergence after Treatment of Symptomatic Convergence Insufficiency in Children. Optom Vis Sci. Jan 2019;96(1):3-16. doi:10.1097/OPX.0000000000001320
7. Guyton DL. The 10th Bielschowsky Lecture. Changes in strabismus over time: the roles of vergence tonus and muscle length adaptation. Binocular vision & strabismus quarterly. 2006;21(2):81-92.
8. Cooper J, Jamal N. Convergence insufficiency-a major review. Optometry (St Louis, Mo. Apr 2012;83(4):137-58.
9. Rouse MW, Borsting E, Deland PN. Reliability of binocular vision measurements used in the classification of convergence insufficiency. Optom Vis Sci. Apr 2002;79(4):254-64.
10. Smelt AF, Assendelft WJ, Terwee CB, Ferrari MD, Blom JW. What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients. Cephalalgia : an international journal of headache. Jan 2014;34(1):29-36. doi:10.1177/0333102413497599
11. Group. CITTS. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Archives of ophthalmology. Oct 2008;126(10):1336-49. doi:126/10/1336 [pii]
