Purpose:

To evaluate and compare the clinical and visual outcomes in subjects implanted with a trifocal intraocular lens (IOL), the AcrySof PanOptix IOL Model (TFNT00) in the US to those observed in patients from Europe, South America, South East Asia and Japan.

Methods:

We report the results of a meta-analysis of 3 to 6 months post-operative uncorrected, best-corrected visual acuity, range of focus and low contrast outcomes from subjects implanted with the TFNT00 IOL. Our report includes the clinical outcomes obtained from prospective, controlled clinical trials that used consistent methods and techniques to evaluate visual outcomes.

Results:

Data was pooled for a total of 557 subjects implanted with TFNT00; of which 53% were white, 35% were Asian, and 12% reported other races. The mean binocular defocus curve from the US FDA trial (N=127) at 6 months post-op indicated a visual acuity 0.1 logMAR (20/25) or better from +0.50 to -2.5D. Similarly, the pooled defocus curve indicated a VA of ≤ 0.1 logMAR from +0.5D to -3.0D. Consistent with the US trial results, binocular uncorrected distance and intermediate (60-66cm) VAs were 20/20; and uncorrected near (40cm) VA was 20/25.

Conclusions:

Visual outcomes from the US registration trial for PanOptix® IOL were similar to outcomes including data pooled from 4 other regions. PanOptix IOL provides patients a continuous 20/25 or better vision from distance to near (33cm/13 inches).