Prospective, randomized, controlled multicenter study of a monofocal EDOF intraocular lens compared with a standard aspheric monofocal intraocular lens.

PURPOSE: To investigate the safety and effectiveness of a monofocal enhanced depth-of-focus intraocular lens (mono-EDOF IOL, xact Mono-EDOF Model ME4) compared with an aspheric monofocal IOL (TECNIS 1-Piece IOL Model ZCB00).

SETTING

Sites in the United Kingdom, France, and Portugal.

DESIGN

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

METHODS

Adults 40 years of age or older with bilateral cataracts, expected postoperative refractive astigmatism of ≤1.0 diopter (D) and calculated lens power 18 to 30 D, underwent implantation of either mono-EDOF or aspheric monofocal IOL in both eyes. Primary endpoints assessed at days 120 to 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

65 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 = .0128), monocular UIVA ( P < .001), and monocular DCIVA ( P < .001). Monocular and binocular defocus curve measurements confirmed increased depth-of-focus for the Mono-EDOF compared with the control IOL by approximately 0.50 D and 0.75 D, 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.