Assessment Of The Binocular Defocus Curve And Contrast Sensitivity In Patients Implanted Bilaterally With A Novel Full Visual Range Trifocal Or Monofocal Intraocular Lens: A Us Prospective, Randomized, Controlled Study.

To evaluate the binocular contrast sensitivity and defocus curve performance in patients undergoing bilateral cataract surgery with the implantation of either a novel trifocal IOL with a full range of vision or a monofocal IOL.

A prospective, multicenter US study 

This randomized, controlled study conducted at 23 US sites included cataract subjects desirous of undergoing bilateral cataract surgery. Subjects meeting the study eligibility criteria were randomized to undergo bilateral implantation of either the full visual range enVista MX60EFH trifocal IOL (study group) or MX60E monofocal IOL (control group). Outcome measures included assessment of the binocular defocus curves from +1.50 D to ‑3.50 D under photopic conditions and binocular contrast sensitivities under photopic (with glare) and mesopic (with and without glare) conditions at postoperative 120-180 days. 

A comparison of the defocus curve showed similar corrected distance vision for both groups. In the intermediate and near vision range (-1.50 to -2.50 D), the trifocal group demonstrated better visual acuity (~0.1 logMAR), which was maintained in the near vision range, whereas in the monofocal group, the visual acuity decreased from ~ 0.3 logMAR to nearly 0.6 logMAR. The trifocal IOL advantage was maintained throughout the extended near-vision range (-2.5 to -3.5 D). Binocular contrast sensitivity in both groups was within ±1 standard deviation of the means reported for the normal population under photopic (with glare) as well as mesopic conditions (with and without glare). 

Defocus curve analysis showed that the full visual range trifocal IOL group exhibited functional vision of 0.2 logMAR or better across 4.0 D defocus range from +1.0 to -3.0 D and the monofocal IOL had defocus range of 2.0 D from +1.0 D to -1.0 D. In the intermediate and near vision range (-1.50 to -2.50 D), the trifocal group demonstrated visual acuity of ~0.1 logMAR. The mean binocular contrast sensitivities were similar in both groups.