Prospective, Randomized, Controlled Multicenter Study of a Monofocal Extended Depth of Focus IOL Compared to a Standard Aspheric Monofocal IOL.

Purpose: Investigate safety and effectiveness of a monofocal enhanced depth of focus intraocular lens (mono-EDoF IOL, xactTM Mono-EDoFTM Model ME4) compared to an aspheric monofocal IOL (TECNIS 1-Piece IOL Model ZCB00).

Setting: Sites in United Kingdom, France, and Portugal.

Design: Prospective, multicenter, controlled, single-masked, randomized 2:1 (test:control) clinical trial.

Methods: Adults ≥40 years of age with bilateral cataracts, expected post-operative refractive astigmatism of ≤1.0D and calculated lens power 18D to 30D underwent implantation of either mono-EDoF or aspheric monofocal IOL in both eyes. Primary endpoints assessed at day 120-180 included monocular uncorrected distance visual acuity (UDVA) and visual disturbances. Secondary endpoints were monocular uncorrected intermediate visual acuity (UIVA) and monocular distance corrected intermediate visual acuity (DCIVA).

Results: Sixty-five patients were randomized; 45 patients (95.2%) with Mono-EDoF and 20 patients (95.2%) with control completed the study. Compared with control, Mono-EDoF had significantly better monocular UDVA (P=0.0128), monocular UIVA (P<0.001), and monocular DCIVA (P<0.001). Monocular and binocular defocus curve measurements confirmed increased depth-of-focus for the Mono-EDoF compared to the control IOL by approximately 0.50D and 0.75D respectively. Contrast sensitivity measured under mesopic conditions with and without glare was similar between groups. Halo or glare was reported by 25.7% and 33.3% of patients in the Mono-EDoF group, respectively, and 22.2% and 25.0%, respectively, in the control group.

Conclusions: The xact Mono-EDoF ME4 IOL is a safe and effective alternative to a monofocal IOL. It provides superior intermediate VA compared with an aspheric monofocal IOL without compromising contrast sensitivity or creating unwanted photic phenomena.