Results from research recently published in the American Journal of Ophthalmology demonstrate positive outcomes following implantation of Bausch + Lomb Corporation’s enVista Envy and monofocal intraocular lenses (IOLs) among cataract surgery patients.
First, let’s get a debrief on the enVista.
B+L’s enVista hydrophobic acrylic IOLs—one of several brands for the company—include both monofocal and toric hydrophobic acrylic IOLs with two key properties: aberration-free optics and distinct lens designs.
- Notably, these designs enable predictability, stable performance, and visual acuity.
But more importantly, the enVista IOLs also feature a few proprietary technologies that ensure they’re scratch resistant (via TruSight Optic), have reduced edge glare (via SureEdge design), and are able to achieve enhanced optic recovery (via StableFlex technology) and be manipulated for a more secure positioning (via AccuSet Haptics).
Now looking at the enVista Envy …
Approved by the FDA in October 2024, the Envy is intended to give wearers a full range of vision correction and an “enviable” tolerance to dysphotopsia.
- See here for more details on its capabilities, targeted vision correction conditions, and indications (hydrophobic and toric hydrophobic acrylic IOLs).
And the enVista monofocal?
This IOL is an updated version of the enVista M60E, equipped with an ultraviolet (UV) light-filtering material to enhance UV cutoff and provide increased UV protection.
Got it. Next up: this study.
The prospective, multicenter, randomized, active-controlled clinical study (NCT03603600) evaluated the safety and effectiveness of the enVista Envy IOL when compared to the enVista monofocal IOL following bilateral implantation in the capsular bag.
A few details on its design:
- The participants: 501 patients (aged 22+) diagnosed with cataracts (see all criteria)
- The setup: Patients randomized into two groups to receive a bilateral IOL implantation of either:
- enVista Envy (n = 332; age 67.6 ± 7.9)
- enVista monofocal (n = 169; age 68.8 ± 7.5)
And what was measured?
Measured at Days 120 to 180 for the first implanted eyes, the primary efficacy endpoints included the photopic binocular:
- Corrected-distance near visual acuity (CDVA)
- Distance-corrected intermediate visual acuity (DCIVA)
- Distance-corrected near visual acuity (DCNVA)
- Distance-corrected visual acuity (DCVA)
Meanwhile, the secondary effectiveness endpoints included uncorrected near visual acuity (UNVA), DCNVA, uncorrected intermediate visual acuity (UIVA), and DCIVA.
- Notably, these were measured at postoperative days 120 to 180.
That was for effectiveness … how about for safety?
The primary safety endpoints included adverse events (AEs) and serious AEs (SAEs) as well as surgical interventions related to the optical properties of the IOL through post-op days 120 to 180.
- See here for secondary safety endpoints (also measured during the same timeframe).
And these findings?
To start, the study completion rate was 94.6% and 92.3% for the Envy and monofocal groups, respectively, out of the original 501 participants.
As for the results: The study met all primary efficacy endpoints.
- Specifically: Envy demonstrated “non-inferiority for monocular CDVA and statistical superiority for monocular DCIVA and DCNVA” versus the monofocal group.
And how did the Envy group vision compare for those other visual outcomes?
Compared to the monofocal group, the Envy group demonstrated better “binocular UIVA, DCIVA, UNVA, and DCNVA” (all p < 0.0001).
In fact: 89.1% of patients in the Envy group achieved binocular UVA of 20/32 or better at all distances, while the group also exhibited a consistent VA of ~0.1 logMAR from -1.50 to -2.50 D.
Now to the safety data.
The study also met all primary safety endpoints, finding:
- No treatment-emergent SAEs related to the Envy lens
- No secondary surgical interventions due to the lenses’ optical properties
- No cumulative or persistent AEs
But were there any AEs at all?
Nearly 50% (49.4%) and 40.8% of participants experienced at least one ocular treatment-emergent AE (TEAE) in the Envy and monofocal IOL groups, respectively.
The most common: Punctate keratitis, increased intraocular pressure (IOP), and vitreous detachment.
- See here for other ocular TEAEs (which occurred in <3% of patients in each group), of which the vast majority were mild to moderate.
And the conclusions based on this?
The study authors recommended that future research include toric versions of the IOLs (among other advice).
But all in all, the Envy IOL was found to demonstrate good visual and refractive outcomes, a favorable dysphotopsia profile, as well as a good astigmatic tolerance.
Compared to the monofocal IOL: The Envy was statistically superior in its visual outcomes.