Study assessing Bausch + Lomb's enVista Envy IOLs meets all primary end points

The study include 501 cataract patients, who were randomized into 2 groups, 1 receiving bilateral implantation of the enVista Envy (n=332), and the other receiving the enVista monofocal IOL (MX60E) (n=169). Image credit: AdobeStock/Oktay

Results published in the American Journal of Ophthalmology demonstrate that enVista Envy (Bausch + Lomb) is statistical superior regarding monocular distance-corrected intermediate visual acuity (DCIVA, 66 cm) and distance-corrected near visual acuity (DCNVA, 40 cm) over the monofocal group in a multicenter, prospective, masked, controlled trial.¹ The study assessed primary efficacy endpoints of monocular corrected distance visual acuity (CDVA), DCIVA, and DCNVA, in addition to binocular DCIVA, DCNVA, uncorrected intermediate (UIVA), and near visual acuity (UNVA) postoperatively between days 120 and 180, according to a news release.

“enVista Envy has been well received as the first premium IOL on the widely used enVista platform,” said Luc Bonnefoy, president of Surgical, Bausch + Lomb, in the release. “Results of this study confirm the advantages that this lens offers – continuous range of vision from distance to near with excellent dysphotopsia tolerance.”

Specifically, the study compared visual, refractive, and patient-reported outcomes following implantation of enVista Envy and the enVista monofocal intraocular lens (IOL) in cataract surgery patients. The study included 501 cataract patients, who were randomized into 2 groups, 1 receiving bilateral implantation of the enVista Envy (n=332), and the other receiving the enVista monofocal IOL (MX60E) (n=169). The primary end points included adverse events and serious adverse events, in addition to surgical interventions related to the topical properities of the IOL during the same postoperative period of day 120-180, the release stated.¹

The study met all primary efficacy endpoints, with the Envy group also demonstrating better binocular UIVA, DCIVA, UNVA, and DCNVA, compared to the monofocal group (all p<0.0001). Envy also demonstrated consistent visual acuity of ~0.1 logMAR from -1.50 to -2.50 D. The 2 groups clocked in a difference in mesopic contract sensitivity without glare with less than the minimum detectable difference of 0.15 logCS.¹

All primary safety end points of the study were also met, with no treatment-emergent serious adverse events related to the study lens. Additionally, no secondary surgical interventions due to the lens’ optical properties, or cumulative or persistent adverse events, were reported.¹

“Trial results mirror what I have seen in my practice,” said Mitchell Shultz, medical director, Shultz-Chang Vision in Northridge, CA, and the study’s lead author. “I have long relied on the enVista platform, and I will continue to rely on Envy as an excellent option for cataract patients seeking an IOL that can provide a full range of vision with minimal visual disturbances, as well as precision astigmatism correction.”

Reference:

1. Bausch + Lomb announces publication of enVista Envy full range of vision intraocular lens pivotal US clinical trial. News release. Bausch + Lomb. September 11, 2025. Accessed September 15, 2025. https://www.bausch.com/newsroom/news/?id=286