ABSTRACT
Purpose: Vision-related disorders, such as refractive errors and binocular vision issues, can cause headaches. The current study evaluates the impact of Neurolens (NL) on individuals with headaches, assessed using the Headache Impact Test (HIT) questionnaire. Methods: 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. Results: Of the subjects randomized, 88% (170/195) completed the study. Overall, subjects reported a greater improvement in HIT score improvement with NL compared with control (mean difference, -1.53 points; 95% confidence interval, -2.8 to -0.26; P = 0.01). In the subgroup with reduced NPC, subjects reported a larger improvement in HIT score improvement with NL but was not statistically significant (mean difference, -1.89 points; 95% confidence interval, -4.27 to -0.47; P = 0.11). Conclusions: NL 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 NL cannot be ruled out with high certainty in the current study. Translational Relevance: Headache is one of the most experienced symptoms by individuals worldwide with vision-related disorders being a primary reason. It is, therefore, critical to screen these disorders before providing a pharmacological intervention, which may have side effects. NL provides an objective way to diagnose and treat digital eyestrain-related headaches.
