On this episode of Interventional Mindset, Preeya K. Gupta, MD, is joined by William F. Wiley, MD, to discuss their experiences with the enVista Envy trifocal intraocular lens (IOL).
Dr. Wiley is a cataract and laser-surgery specialist and the Medical Director of the Cleveland Eye Clinic in Cleveland, Ohio.
Overview of the enVista Envy IOL
In October 2024, the FDA approved the enVista Envy IOL (Bausch + Lomb) in both a spherical and toric variety to join the growing enVista IOL product line comprising monofocal and toric hydrophobic acrylic IOLs.
With this new addition, the Envy trifocal IOL provides a continuous range of vision with exceptional dysphotopsia tolerance for cataract patients while simultaneously correcting both presbyopia and astigmatism.1
The Envy IOL features an ActiveSync optic designed to enhance image contrast by evenly distributing light in photopic conditions and prioritizing distance in mesopic conditions as well as ClearPath technology to reduce light scattering.2 Dr. Wiley noted that his practice was involved in the FDA trial for the enVista Envy IOL, and he quickly saw that patients were very happy with the results.
What about the enVista Envy Toric IOL?
The enVista Envy Toric IOL has an aspheric apodized diffractive optic on the anterior lens surface, providing 1.60D of intermediate and 3.1D of near add powers. Additionally, the posterior surface is designed to have -0.15μm of spherical aberration to compensate for the positive spherical aberration of the average human cornea.2
The toric variety is available in both low and high toric powers (ranging from 1.25D to 5.75D at the IOL plane), which is roughly 0.25D lower than the other platforms, explained Dr. Wiley. While this may not seem like a significant difference, many of his patients fit within this low toric power, and are thus candidates for this next-generation trifocal technology.
Moreover, correcting as much astigmatism as possible is critical for optimal results. A study by Dr. Gupta that evaluated the efficacy of treating < 1.0D of astigmatism with laser arcuate incisions (LRI) using the Gupta-Wörtz Formula found a statistically significant reduction in refractive astigmatism post-operatively despite having low cylinder pre-operatively.
Further, this reduction in astigmatism led to improved post-operative vision compared to those who underwent conventional cataract surgery.4 As such, the enVista Envy IOL allows surgeons to effectively address low astigmatism, which still impacts vision and is significantly more prevalent than very high levels of astigmatism.
To learn more about the unique features of the enVista Envy IOL, watch the full interview!
Understanding the voluntary recall of enVista IOLs
In March of this year, Bausch+Lomb announced a voluntary recall of IOLs in the enVista platform (including the Envy) due to an increase in reports of complications—specifically, toxic anterior segment syndrome (TASS). Although these TASS reports made up an extremely small percentage of implanted lenses, Brent Saunders, CEO of Bausch + Lomb, stated that the products would be kept off the market for patient safety.
After investigation, the company found that the issue stemmed from a raw material used in certain lots of the enVista IOLs that were delivered by a different vendor. Consequently, enhanced inspection protocols were implemented, and within a few weeks, the enVista IOLs were returned to the market.
Fortunately, this issue has been fully resolved, and both Drs. Gupta and Wiley noted that they didn’t have any cases of TASS and have continued to observe excellent visual results using the enVista lenses since they were rereleased.
Data on vision correction with the enVista Envy IOL
Dr. Wiley noted that trifocal lenses need to strike a balance in providing a full range of vision while minimizing the risk of nighttime dysphotopsias. In his experience, presbyopic patients who received the enVista Envy IOL haven’t complained of poor near vision, and data from the Canadian clinical trial backs this.
In the study (n = 110), 91% of patients had little to no difficulty reading a mobile screen, 94% had little to no difficulty viewing close objects, and 95% had little to no difficulty reading a computer screen.2
Further, outcome data at 4 to 6 months post-op in the US clinical trial (n = 309) illustrated its tolerance to dysphotopsia as follows:2
- Glares:
- Percentage of patients with little to no bothersomeness: 88%
- Percentage of patients with severe disturbance: 3%
- Halos:
- Percentage of patients with little to no bothersomeness: 80%
- Percentage of patients with severe disturbance: 6%
- Starbursts:
- Percentage of patients with little to no bothersomeness: 91%
- Percentage of patients with severe disturbance: 3%
To review new data on the enVista Envy IOL, check out the Glance story Pivotal study showcases enVista Envy IOL's full range of vision!
Conclusion
Advances in trifocal technology are consistently improving surgeon confidence and patient outcomes, making lenses like the enVista Envy more appealing to both patients and surgeons.
Dr. Gupta noted that as surgeons gain confidence in the technology, their enthusiasm encourages patient approval, creating a positive cycle of trust as patients report improvements in their quality of life with the help of next-generation trifocal technology.
