ABSTRACT
BACKGROUND: The increased use of digital devices has implications for health and, particularly, the eyes, due to Computer Vision Syndrome (CVS). Millions of individuals of all ages are at risk of CVS, and its prevalence ranges from 25% to 93%. This trial will evaluate the effectiveness of the Super Enhanced Single Vision Lens 01 (SESL01) versus standard single vision lens in reducing symptoms of CVS assessed by the Computer Vision Syndrome Questionnaire (CVS-Q®) scores. METHOD: A double-blind, two-arm parallel randomized controlled trial will be conducted at the University of Central Lancashire, Preston (UK), recruiting students and staff with CVS-Q score ≥ 6. A 1:1 randomization and a sample size of 300 participants will be sufficient to detect a 2-point difference in the CVS-Q score between the intervention and control groups with an alpha of 5%, two-sided, allowing for a dropout of 10%. The control group will use standard single vision lenses, and the intervention group SESL01. The primary outcome to week 14 will be the difference in the CVS-Q score between SESL01 and standard single vision lenses. Secondary outcomes include the percentage of participants with CVS-Q score < 6 (no symptoms) and CVS-Q score ≥ 6 (symptoms) in the SESL01 and the standard single vision group at weeks 6, 10 and 14; the percentage of participants in each group with a total CVS-Q score < 6, 6-12, 13-19, and ≥ 20 at weeks 6, 10 and 14. The primary analysis will be the intention to treat. DISCUSSION: Findings may inform decisions about adopting the SESL01 lenses to reduce CVS. TRIAL REGISTRATION: clinicaltrial.gov identifier: NCT05545878. Registered: Sept. 19, 2022.