Clinical Results Of A New Enhanced Monofocal Iol To Extend Range Of Vision

• To assess visual acuity, pupil dependency, and refractive predictability of a new enhanced monofocal IOL designed to extend range of vision

Multicenter study in Asia and Europe

• Prospective, randomized multi-center, double masked clinical trail at 14 centers. Enrollment of 190 bilateral subjects has been completed. 130 subjects have been randomly assigned to the new enhanced monofocal IOL group and 60 subjects assigned to the standard monofocal IOL group. At the 1 month postop exam the authors assessed monocular distance-corrected acuity at 4 m and 66 cm, residual refractive error and predictability, and pupil dependency of visual acuity among first eyes implanted. 73 subjects have been evaluated at the 1 month postop exam.

• : One month results among 49 enhanced monofocal IOL subjects and 24 standard monofocal IOL subjects demonstrate a significant improvement in mean logMAR visual acuity at 66 cm of approximately 1 line (0.11logMAR vs 0.20 logMAR, p=0.031). No significant difference was observed in best-corrected distance vision (-0.01 logMAR vs -0.04 logMAR, p=0.316). Refractive predictability was excellent in both IOL group in terms of deviation from target postop spherical equivalent 0.25 D or less (60% vs 55%), 0.50 D or less (87% vs 77%) or 0.75 D or less (100% vs 91%).  There were no correlations between visual acuity at 66 cm and pupil diameter in either the enhanced monofocal IOL group (0.12, p=0.41) or the standard IOL group (0.05, p=0.83).

• A new enhanced monofocal IOL to extend range of vision significantly improves visual acuity at 66 cm compared to a leading standard monofocal IOL without degrading best-corrected visual acuity. Results were not influenced by pupil diameter and were associated with excellent refractive predictability. Further postoperative follow-up is ongoing.