Discover the Enviable Dysphotopsia Profile of enVista Envy™

In a recent conversation, Dr. Adam Muzychuk, clinical assistant professor of surgery at the University of Calgary, the scientific meeting chair for the Eye Physicians and Surgeons Association of Alberta, and the skills transfer course director for Cornea and External Disease for the Canadian Ophthalmological Society, discussed the dysphotopsia results from the pivotal Canadian study of the new enVista Envy™ full range of vision (FROV) IOL, for which he was an investigator.

Prior Experience With Diffractive Optics

According to Dr. Muzychuk, his experience with presbyopia-correcting IOLs started in residency with the last generation of diffractive technologies preceding modern trifocal lenses. Based on that experience, he said, “When I was a resident physician, I had told myself I would never recommend diffractive technology in my own practice because I felt the disadvantages outweighed the advantages for patient outcomes. However, I do evaluate new lens technologies as they come to market, and after hearing about the design, I was eager to evaluate the enVista Envy full range of vision lens.”

Dr. Muzychuk also noted that, “As cataract surgeons, we have a shared goal with our patients for them to be as happy as possible after lens implantation. They may achieve great visual outcomes, but with diffractive optics, there can be considerable dysphotopsias such as glare, halos, and starbursts. This may affect their satisfaction with the outcome of the surgery as patients have high expectations for an advanced technology IOL.”

Dysphotopsia Profile in the Pivotal Canadian Clinical Study of enVista Envy

Dr. Muzychuk was one of nine investigators in the pivotal Canadian study, which included 165 subjects bilaterally for 329 eyes.¹ According to Dr. Muzychuk, he was “excited about this opportunity because I hadn’t yet found a full range of vision lens that I wanted to consistently recommend, and I enjoy using the enVista as my go-to monofocal and toric platform.”

Study Design

In this prospective, randomized, blinded, controlled clinical study, patients with bilateral cataracts were enrolled at one of nine study sites in Canada and randomized to receive either enVista Envy lenses bilaterally or enVista monofocal lenses bilaterally. They were followed up to postoperative Visit 4, which occurred from Day 120 to Day 180 after the IOL implantation in the second eye.¹

Results

Dr. Muzychuk commented, “One of the major take-home points of the Canadian study (n=110), for me, was seeing how well enVista Envy performed with respect to dysphotopsias. This was evident to me as an investigator even before the collective study results were available.” Of the small percentage that did report visual disturbances, the reported severity was low. In this study at the 4-6–month post-op visit, 96% of patients were “not at all” or “a little” bothered by glare, 88% for halos, and 94% for starbursts.¹ “These patient-reported rates of dysphotopsias are stunningly low and very close to what you might expect from non-diffractive technologies such as extended depth of focus (EDOF) lenses.”

^a Respective patient-reported outcome data at 4-6–month post-op (non-head-to-head) from enVista Envy US clinical study (n=309) and enVista Envy Canadian clinical study (n=110).

“These results give me the confidence to recommend this FROV technology to patients and have changed my perception of what is possible with diffractive IOLs.”
- Dr. Adam Muzychuk

Dr. Muzychuk remarked, “As a surgeon who has previously recommended non-diffractive EDOF technologies, I can’t stress how important results like these are in evaluating a new technology to incorporate into my practice.”

Similar results were observed in the pivotal US Clinical study, a trial in 332 subjects implanted bilaterally with enVista Envy for a total of 664 eyes.²

Conclusion

In closing, Dr. Muzychuk noted, “I’m going to be reevaluating our lens counseling when it comes to enVista Envy. Based on my early experience with this lens, I am going to recommend diffractive technologies more frequently than I have in the past. The main reason for this change is that enVista Envy demonstrated incredibly low rates of reported dysphotopsias. To me, this increases the confidence I have in recommending this technology to my patients seeking spectacle independence, even if they initially wanted to avoid other diffractive technologies because of these potential adverse effects. This will also add a new dimension to the conversation with patients who were previously turning to non-diffractive technologies such as non-diffractive EDOF lenses, where their concerns revolved around bothersome dysphotopsias.”

References

Data on File, Bausch + Lomb. Canadian Clinical Study CSR.
Data on File, Bausch + Lomb. US Clinical Study CSR.

enVista Envy toric and non-toric IOL Indications and Important Safety Information

Indications: The enVista Envy hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.

The enVista Envy toric hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.

Warnings/Precautions: Physicians should weigh the potential risk/benefit ratio before implanting the enVista Envy lens under any of the circumstances or conditions outlined in the Instructions for Use labeling. Some visual disturbances may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or radial lines around point sources of light (starbursts) under nighttime conditions, glare, double vision, haziness and blurred vision. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions such as nighttime driving. As with other trifocal IOLs, there is a possibility that visual disturbances may be significant enough that the patient will request explant of the IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients, therefore, patients implanted with trifocal IOLs should exercise caution when driving at night or in low light or poor visibility conditions. Care should be taken to achieve IOL centration as IOL decentration may result in patients experiencing visual disturbances or suboptimal vision under certain lighting conditions. The surgeon must target emmetropia to achieve optimal visual performance. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). Please provide a copy of the Patient Information Brochure, which can be found at www.bausch.com/IFU. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs earlier in its progression than patients with monofocal IOLs. This may be due to the reduced contrast sensitivity observed with multifocal IOLs.

Additional Precautions for Toric IOLs: The enVista Envy Toric IOL has not been evaluated in a clinical study. In general, astigmatism that is corrected with a higher cylinder power IOL can result in clinically significant residual astigmatism. The effect of residual astigmatism at distance, intermediate, and near was evaluated in a clinical study of patients who had been implanted with non-toric enVista Envy IOLs and were induced with cylinder power to simulate various levels of residual astigmatism. If a secondary surgical intervention is necessary to reposition the IOL, explantation should be considered as some patients may have recurrent or persistent issues related to rotational instability and misalignment.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: See the Directions for Use for a complete listing of indications and important safety information.

Prior Experience With Diffractive Optics

Dysphotopsia Profile in the Pivotal Canadian Clinical Study of enVista Envy

Study Design

Results

Conclusion

Sign up to receive updates on Bausch + Lomb Surgical