enVista EY Beyond Lens for Cataracts

Not currently recruiting at 17 trial locations

Overseen By Jennifer Laskowski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Alpha blockers

Disqualifiers: Corneal pathology, Uncontrolled glaucoma, Retinal detachment, Diabetic retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 180

Duration: Immediate post-surgery period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new lens implant called the enVista Beyond EY, which may improve vision for those undergoing cataract surgery. The researchers aim to determine if this lens is safe and effective compared to the standard enVista MX60E monofocal IOL. Individuals with significant cataract-related vision problems who anticipate better vision after surgery might be suitable candidates. Participants must have cataracts and some vision issues but no other serious eye conditions. As an unphased trial, this study allows patients to contribute to innovative research that could enhance cataract treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are using any systemic or topical drugs that interfere with visual performance, pupil dilation, or iris structure, you may need to stop them 30 days before randomization.

What prior data suggests that the enVista Beyond EY IOL is safe for cataract patients?

Research shows that the enVista Beyond EY Intraocular Lens (IOL) offers a safe option for people with cataracts. Studies have found that patients generally tolerate this lens well, with no major reports of serious side effects. The lens material helps it remain stable and clear in the eye.

Moreover, the enVista lens has been used successfully in other eye treatments, demonstrating positive safety results. While all medical treatments carry some risks, the enVista Beyond EY IOL has a history of being a safe choice for improving vision in people with cataracts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard cataract treatments that typically use monofocal intraocular lenses (IOLs), the enVista Beyond EY IOL offers an extended depth of focus. This feature allows for improved vision over a range of distances, potentially reducing the need for glasses after surgery. Researchers are particularly excited because this can enhance the quality of life for patients, offering more flexibility in daily activities without the constant need for corrective eyewear. Additionally, the enVista Beyond EY IOL may provide a more natural visual experience compared to traditional monofocal lenses.

What evidence suggests that this trial's intraocular lenses could be effective for cataracts?

Research has shown that the enVista Beyond EY Intraocular Lens (IOL), which participants in this trial may receive, offers a promising option for those undergoing cataract surgery. Studies indicate that this lens improves vision at various distances by providing a wider range of focus. It is also designed to reduce common issues like glare and halos that some lenses can cause. Many patients have reported clearer vision and a better overall visual experience with the enVista Beyond lens. Made from a special material, it may also help prevent lens clouding over time. Overall, the enVista Beyond EY IOL has proven effective in enhancing vision quality for those with cataracts. This trial will compare the enVista Beyond EY IOL with the enVista MX60E monofocal IOL, which serves as an active comparator. ^{1 2 3 5 6}

Who Is on the Research Team?

Rosangela Sonner

Principal Investigator

Bausch & Lomb Incorporated

Are You a Good Fit for This Trial?

This trial is for individuals planning to undergo cataract extraction and who wish to receive a new type of lens implant called the enVista Beyond IOL. Specific eligibility criteria are not provided, but typically participants should be in good general health with no other eye diseases.

Inclusion Criteria

Contact lens wearers must demonstrate a stable refraction in both eyes

Apart from cataracts, my eyes are healthy.

Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Research Ethics Board (REB) approved ICF and authorization as appropriate for local privacy regulations

Exclusion Criteria

I have glaucoma that is not under control.

I might need more eye surgery.

I have a history of chronic or recurrent eye inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery and are bilaterally implanted with either the enVista Beyond EY IOL or enVista MX60E monofocal IOL

Immediate post-surgery period

Surgery and immediate post-operative visits

Follow-up

Participants are monitored for visual acuity outcomes and safety, with assessments including BCDVA, DCNVA, and DCIVA

24 weeks

Multiple post-operative visits up to Day 180

Long-term follow-up

Participants may continue to be monitored for long-term safety and effectiveness

Beyond 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• enVista Beyond (EY) EDF Intraocular Lens

Trial Overview The study compares two types of intraocular lenses (IOLs): the new enVista Beyond Hydrophobic Acrylic Extended Depth of Focus IOL and the established TECNIS monofocal IOL. Participants will have one of these lenses implanted during cataract surgery.

How Is the Trial Designed?

Group I: enVista Beyond EY IOL Experimental Treatment 1 Intervention

Subjects implanted with enVista Beyond Extended Depth of Focus (EDF) Intraocular Lens (IOL) Model EY

Group II: enVista MX60E monofocal IOL Active Control 1 Intervention

Subjects implanted with enVista MX60E monofocal IOL

enVista Beyond (EY) EDF Intraocular Lens is already approved in United States, European Union for the following indications:

Approved in United States as enVista Beyond for:

• Cataract extraction and correction of aphakia

Approved in European Union as enVista Beyond for:

• Cataract extraction and correction of aphakia

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University

Published Research Related to This Trial

The study evaluated 45 eyes with low-grade epiretinal membrane (ERM) and found that their visual outcomes after implantation of the AcrySof® Vivity® intraocular lens (IOL) were comparable to 50 control eyes without ERM, indicating the lens's efficacy in this condition.

While uncorrected intermediate visual acuity and mesopic contrast sensitivity were significantly worse in eyes with ERM, overall visual acuity was similar between both groups, suggesting that the Vivity IOL can still be beneficial for patients with low-grade, reversible ERM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes after implantation of extended depth-of-focus AcrySof® Vivity® intraocular lens in eyes with low-grade epiretinal membrane. Jeon, S., Choi, A., Kwon, H.[2022]

Patients with diffractive extended depth-of-focus (EDF) intraocular lenses (IOLs) showed better binocular visual acuity at intermediate distances (0.5 and 0.7 m) compared to those with monofocal IOLs, indicating enhanced visual performance for everyday activities.

Both IOL types demonstrated similar overall visual function and contrast sensitivity, suggesting that while EDF IOLs excel in intermediate vision, they do not compromise other aspects of visual performance over a 2-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual function in eyes with diffractive extended depth-of-focus and monofocal intraocular lenses: 2-year comparison. Hisai, T., Takada, K., Tokuda, S., et al.[2023]

The study compared five different extended depth of focus intraocular lenses (EDOF IOLs) using an optical bench, revealing that the AcrySof IQ Vivity lens provided the best light energy for intermediate vision, while the Isopure and Vivinex Impress lenses excelled in distance vision under specific conditions.

Overall, the lenses varied in their ability to distribute light between far and intermediate vision, indicating that patients may experience different visual outcomes depending on the specific EDOF lens chosen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Through-Focus Response of Extended Depth of Focus Intraocular Lenses. Pieh, S., Artmayr, C., Pai, V., et al.[2022]

The novel extended depth of focus (EDOF) intraocular lens (IOL) demonstrated comparable uncorrected distance visual acuity (UCDVA) to monofocal IOLs, indicating its effectiveness in maintaining distance vision after surgery.

Patients with the EDOF IOL achieved significantly better distance corrected intermediate visual acuity (DCIVA) compared to those with monofocal IOLs, with 68% achieving better than 20/23 vision, and reported no significant optical disturbances like halos or starbursts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Non-Diffractive Extended Depth of Focus Intraocular Lens - First Results from a Prospective Study. Tahmaz, V., Siebelmann, S., Koch, KR., et al.[2022]

The LuxSmart EDOF intraocular lens (IOL) demonstrated significant improvements in visual acuity after cataract surgery, with patients achieving a mean uncorrected distance visual acuity of 0.09 logMAR at 6 months, compared to 0.57 logMAR preoperatively.

Over 90% of patients reported high satisfaction with their vision post-surgery, indicating that the EDOF IOL effectively enhances visual outcomes and patient quality of life, with only one reported case of suspected vitreomacular traction, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of extended depth-of-focus hydrophobic intraocular lens with an optic concept based on combination of high-order aberrations. Stodulka, P., Pracharova, Z.[2023]

The study evaluated the safety and effectiveness of the enVista® MX60 intraocular lens (IOL) in 255 eyes of adults who underwent cataract surgery, showing excellent visual outcomes with 62.2% achieving 20/20 vision and 97.8% achieving 20/40 vision or better within 6 months post-surgery.

The MX60 IOL demonstrated a high safety profile, with only one eye (1.0%) requiring additional treatment for capsular opacification and no reports of glistenings, indicating a favorable outcome in standard clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) - results of a European and Asian-Pacific study. Heiner, P., Ligabue, E., Fan, A., et al.[2022]

In a study of 191 eyes from 133 cataract patients, the implantation of the CT LUCIA 621P IOL resulted in excellent visual outcomes, with 74.9% of eyes achieving uncorrected visual acuity of 20/25 or better.

The procedure demonstrated high refractive predictability, with 84.8% of eyes within ±0.50D of emmetropia, and no significant adverse events related to the IOL were reported, indicating a safe and effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Clinical Experience with a New Hydrophobic Acrylic Single-Piece Monofocal Intraocular Lens. Schallhorn, SC., Teenan, D., Venter, JA., et al.[2023]

The Mini Well Ready extended depth of focus (EDOF) intraocular lens (IOL) demonstrated good visual acuity across different distances, with 95.31% of patients achieving a fluent reading speed of 80 words per minute without needing distance correction.

The lens provided enhanced contrast sensitivity and had a low incidence of photic phenomena, with only one reported case of moderate photophobia, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European, Multicenter, Prospective, Non-comparative Clinical Evaluation of an Extended Depth of Focus Intraocular Lens. Auffarth, GU., Moraru, O., Munteanu, M., et al.[2021]

In a study of 76 eyes from 38 patients undergoing cataract surgery, the IC-8 intraocular lens (IOL) demonstrated significantly better uncorrected distance visual acuity (UDVA) compared to the Symfony IOL, particularly under photopic and mesopic conditions.

Both types of extended depth-of-focus IOLs resulted in high patient satisfaction, but the IC-8 group reported higher satisfaction levels, indicating a potential preference for this lens design in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual performance comparison of 2 extended depth-of-focus intraocular lenses. Schojai, M., Schultz, T., Jerke, C., et al.[2021]

In a study of 64 patients who underwent cataract surgery, the Lucidis Extended Depth of Focus (EDOF) intraocular lens (IOL) provided significantly better distance, low contrast, and near vision compared to the IsoPure and Synthesis+ IOLs.

All EDOF IOLs tested, including Lucidis, demonstrated good distance vision without causing issues like glare or halos, making them effective options for patients seeking improved vision post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative evaluation of three extended depth of focus intraocular lenses. Lesieur, G., Dupeyre, P.[2023]

Citations

1. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-the-safety-and-effectiveness-of-the-envista-r-beyond-ey-edf-intraocular-lens-in-s

Study to Evaluate the Safety and Effectiveness of the enVista ... This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus ...

2. withpower.com withpower.com/trial/phase-cataract-3-2024-5b892

enVista EY Beyond Lens for Cataracts This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus ...

3. bauschsurgical.com bauschsurgical.com/resources/peer-opinions/envista-is-a-great-lens-for-the-imperfect-eye/

enVista® Is a Great Lens for the Imperfect Eye enVista is an advanced aberration-free hydrophobic acrylic IOL that provides a balance between depth of field and image quality.

4. cms.gov cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved/g240026-nct06333015

G240026-NCT06333015 A prospective, multicenter, randomized, controlled clinical study to evaluate the safety and effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3974695/

Safety and effectiveness of a single-piece hydrophobic ... Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study · Peter Heiner.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240005B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) This was a prospective, multicenter, randomized, active-controlled binocularly implanted study of the enVista one-piece hydrophobic acrylic ...