A Prospective, Multicenter, Randomized, U. S. Clinical Trial Evaluating The Visual And Refractive Outcomes Following Bilateral Implantation Of A Novel Full Visual Range Trifocal R Monofocal Intraocular Lens.

To compare the monocular and binocular visual acuities at far, intermediate, and near distances and refractive outcomes in patients implanted bilaterally with either a novel trifocal intraocular lens (IOL) or a monofocal IOL.

Prospective, multicenter, randomized, controlled clinical trial conducted at 23 US sites with 24 Inestigators.

This study enrolled a total of 501 cataract subjects undergoing cataract surgery and bilateral implantation of a full visual range enVista MX60EFH trifocal (N = 332) IOL or the enVista MX60E monofocal IOL (N =169). Outcome measures were monocular corrected distance visual acuity (CDVA) at 4 m, monocular and binocular distance-corrected intermediate (DCIVA) at 66cm and distance-corrected near visual acuity (DCNVA) at 40 cm at postoperative 120-180 days.

Postoperatively, the mean monocular CDVA in the trifocal group was statistically non-inferior to the mean CDVA in the monofocal group  (0.02 ± 0.10 vs -0.02 ± 0.09 logMAR) (noninferiority margin <0.1 logMAR). The mean monocular DCIVA (0.12 ± 0.12 vs 0.35 ± 0.16 logMAR; p<0.0001) and DCNVA (0.15 ± 0.13 vs 0.55 ± 0.17 logMAR; p<0.0001) were significantly better in the trifocal group compared to the monofocal group. Similarly, the mean postoperative binocular DCIVA (0.04 ± 0.10 vs 0.27 ± 0.15 logMAR; p <0.0001) and DCNVA (0.08 ± 0.10 vs 0.46 ± 0.15 logMAR; p <0.0001) were better in the trifocal group than the monofocal group. Mean MRSE was ‑0.14±0.39 D in the trifocal group and -0.14±0.40 D in the monofocal IOL group.

The study demonstrated comparable distance visual acuity in both the IOL groups. The full visual range trifocal IOL showed statistical superiority to the monofocal IOL for mean monocular and binocular distance-corrected visual acuities at intermediate and near. Mean binocular DCIVA was more than 2 lines better, and mean DCNVA was approximately 4 lines better in the trifocal group compared to the monofocal IOL group.