Purpose: To compare the objective and subjective visual performance of a novel contact lens which extends depth of focus by deliberate manipulation of higher-order spherical aberrations and a commercially available zonal-refractive multifocal lens.
Methods: A prospective, cross-over, randomized, single-masked, short-term clinical trial comprising 41 presbyopes (age 45 to 70 years) wearing novel Extended Depth of Focus lenses (EDOF) and ACUVUE OAYS for Presbyopia (AOP). Each design was assessed on different days with a minimum overnight wash-out. Objective measures comprised high-contrast visual acuity (HCVA, logMAR) at 6 m, 70 cm, 50 cm, and 40 cm; low-contrast visual acuity (LCVA, logMAR) and contrast sensitivity (log units) at 6 m; and stereopsis (seconds of arc) at 40 cm. HCVA at 70 cm, 50 cm, and 40 cm were measured as "comfortable acuity" rather than conventional resolution acuity. Subjective performance was assessed on a 1-10 numeric rating scale for clarity of vision and ghosting at distance, intermediate and near, overall vision satisfaction, ocular comfort, and lens purchase. Statistical analysis included repeated measures ANOVA and paired t tests.
Results: HCVA, clarity of vision, and ghosting with EDOF were significantly better than AOP (p < 0.01); however, differences were dependent on testing distances and add groups. Post hoc analysis showed EDOF was significantly better than AOP for HCVA at 70 cm (0.11 ± 0.11 vs. 0.21 ± 0.16, p < 0.001), 50 cm (0.26 ± 0.17 vs. 0.36 ± 0.18, p = 0.003), 40 cm (0.42 ± 0.17 vs. 0.52 ± 0.21, p = 0.001), and LCVA at 6 m (0.22 ± 0.08 vs. 0.27 ± 0.12, p = 0.024). EDOF was significantly better than AOP for clarity of vision at distance (7.7 ± 1.6 vs. 6.8 ± 2.3, p = 0.029), intermediate (8.8 ± 1.4 vs. 7.0 ± 2.2, p < 0.001), and near (7.4 ± 2.4 vs. 5.2 ± 2.7, p < 0.001), ghosting at distance (9.1 ± 1.2 vs. 8.1 ± 2.5, p = 0.005), and overall vision satisfaction (7.6 ± 1.6 vs. 6.0 ± 2.6, p < 0.001). More participants chose to purchase EDOF compared to AOP (61 vs. 39%) and significantly more chose to only-purchase EDOF compared to only-purchase AOP (27 vs. 5%, p = 0.022).
Conclusions: When compared with AOP, EDOF lenses provide better intermediate and near vision performance in presbyopic participants without compromising distance vision.