Visual performance of phase alteration utilizing sub-elements lenses for potential myopia management

PURPOSE: To compare the visual performance (VP) of P.A.U.S.E. spectacle lenses (tests) against defocus incorporated multiple segments (DIMS; control). METHODS: This randomized, single-masked study included 48 participants aged 18-41 years who wore five tests (T1, T2, T4, T5, T6) and DIMS. VP was assessed through the full-lens and inferior treatment zone. Full-lens visual-acuity (VA) based measurements comprised monocular high- and low-contrast VA (HCVA/LCVA) at 6 m and binocular HCVA at 6 m and 40 cm. Assessments through the treatment zone comprised HCVA at 40 cm and subjective ratings (1-10 scale) of near vision-clarity and ease-of-reading. VP was assessed after 3 days of wear (full-lens) using subjective ratings of vision-clarity, night-vision, vision-while-walking, eyestrain, overall-vision-satisfaction, and willingness-to-purchase (yes/no: based on vision and myopia management efficacy). Analyses were performed using linear mixed models and the X2 test. Significance was set at 5%. RESULTS: Full-lens binocular HCVA at 40 cm was significantly better with three tests (T2, T4, T5) compared to DIMS (p ≤ 0.022), whereas there were no differences between any test and DIMS for monocular or binocular HCVA at 6 m (p > 0.5). Full-lens monocular LCVA at 6 m was significantly better with DIMS compared to T4 (p = 0.0057). Through the treatment zone, four tests (T2, T4, T5, T6) were significantly better than DIMS for binocular HCVA at 40 cm (p < 0.0001), near vision-clarity (p ≤ 0.0011) and ease-of-reading (p ≤ 0.0014). T2 was rated significantly higher than DIMS for night-vision (p = 0.0085) and overall-vision-satisfaction (p = 0.0495), whereas DIMS was rated higher than T1 for vision-clarity (p = 0.0001). There were no significant differences between DIMS and any test for other subjective ratings (p > 0.07), nor willingness-to-purchase based on vision (p > 0.2) or myopia management efficacy (p > 0.6). CONCLUSIONS: Most of the test lenses achieved better VP through the treatment zone compared to the DIMS control. T2 showed better overall VP compared to DIMS, whereas DIMS showed better overall VP compared to T1.