Neurolenses Demonstrate Headache Relief in New Study
Neurolens announced results of a company-sponsored study evaluating the impact of Neurolens prescription lenses on individuals with headaches.
The six-item Headache Impact Test (HIT-6) was designed to provide a global measure of adverse headache impact by assessing the adverse impact of headaches on social functioning, role functioning, vitality, cognitive functioning and psychological distress—while also measuring the severity of headache pain. In the multi-site study (10 optometry practices, 195 patients), published in Translational Vision Science & Technology, subjects (18–60 years) with good stereoacuity and a HIT score of ≥56 points were enrolled. Each subject wore both control lens and NL for 30 ± 10 days each. The primary outcome of the study was to assess the difference in the HIT score between the two treatments.
Of the subjects randomized, 88% (170/195) completed the study. Overall, subjects reported a greater improvement in HIT score improvement with Neurolens compared with control (mean difference, −1.53 points; 95% confidence interval, −2.8 to −0.26; P=0.01). In the subgroup with reduced near point of convergence (NPC), subjects reported a larger improvement in HIT score improvement with Neurolens but was not statistically significant (mean difference, −1.89 points; 95% confidence interval, −4.27 to −0.47; P = 0.11).
The study authors concluded that Neurolens produced a statistically significant decrease in the impact of headaches on individuals’ quality of life compared with placebo. Although the overall magnitude of the decrease was not clinically significant, a clinically meaningful improvement with Neurolens cannot be ruled out with high certainty in the current study.
