Vision Performance of a 3-Zone Progressive™ Design Kalifilcon A Silicone Hydrogel Multifocal Contact Lens is Not Influenced by Pupil Size: Findings from a Multicenter Clinical Study.

PURPOSE: Factors including age, refractive error, and luminance can affect pupil size and may influence the performance of multifocal contact lenses (MFCLs). This post-hoc analysis aimed to investigate correlations between pupil size and vision performance of a 3-Zone Progressive™ design, daily disposable silicone hydrogel (kalifilcon A) MFCL.

METHODS

Habitual MFCL wearers aged ≥40 years were enrolled in a 3-week, single-arm, bilateral, open-label study to assess near, intermediate, and distant vision performance. Pupil sizes were recorded at dispensing, along with binocular high-contrast visual acuity (VA) by logMAR. VA was assessed at 1- and 3-weeks' follow-up for distance, intermediate, and near vision, and participants rated vision performance using a 0-100 scale (100=most favorable) at both these follow-ups. Responses with score ≥50 were considered favorable. Pearson correlation coefficient (r) was used to determine the correlation significance.

RESULTS

Pupil size ranged from 2.0 mm to 7.0 mm. Mean logMAR VA was -0.009, 0.046, and 0.114 (1 week), and -0.012, 0.046, and 0.115 (3 weeks) for distance, intermediate, and near vision, respectively. Statistical analysis of the VA distribution found no significant correlation between VA and pupil size after 1 week of MFCL wear for distance or near vision (r2=0.003 and 0.006, respectively; both p≥0.05), and a weak but statistically significant correlation between intermediate VA and pupil size (r2=0.017; p<0.05). No correlations were observed after 3 weeks for any distance (all p≥0.05). Participants rated subjective vision highly (84.0±19.9, 89.2±11.8, and 82.5±18.5, respectively at 1 week, and 84.6±18.0, 89.3±12.6, and 84.2±17.9, respectively at 3 weeks). Responses were favorable at both visits (p<0.05). Correlations between vision rating and pupil size were not significant at either visit (p≥0.05).

CONCLUSION

The kalifilcon A daily disposable silicone hydrogel MFCL delivers stable VA and significantly favorable (p<0.05) ratings at all distances for patients with a wide range of pupil sizes.