enVista EY Beyond Lens for Cataracts

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Alpha blockers

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes.

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 data supports the effectiveness of the enVista Beyond treatment for cataracts?

Research on similar extended depth-of-focus intraocular lenses (IOLs) shows that they can improve visual performance and satisfaction after cataract surgery, suggesting that enVista Beyond may offer similar benefits.

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Is the enVista EY Beyond Lens for Cataracts safe for humans?

The enVista lens, which is a type of intraocular lens (IOL) used in cataract surgery, has been studied for safety and effectiveness. Research shows it is generally safe for use in humans, with no major safety concerns reported in studies involving similar lenses.

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What makes the enVista Beyond EY EDF Intraocular Lens treatment unique for cataracts?

The enVista Beyond EY EDF Intraocular Lens is unique because it is designed to provide an extended depth of focus, allowing patients to see clearly at multiple distances without the need for additional corrective lenses. This is achieved through a non-diffractive design, which differs from traditional lenses that typically focus on a single distance.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Site 113 Garden City, NY

Site 112 San Antonio, TX

Site 107 Bloomington, MN

Site 108 Northridge, CA

More Trial Locations

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated Lead Sponsor

References

1. Germany 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. [2022] To evaluate the clinical outcomes of extended depth-of-focus (EDoF) AcrySof® Vivity® intraocular lens in eyes with low-grade epiretinal membrane (ERM).

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Non-Diffractive Extended Depth of Focus Intraocular Lens - First Results from a Prospective Study. [2022] To evaluate a novel hydrophobic, non-diffractive, extended depth of focus (EDOF) intraocular lens (IOL) design in comparison to two monofocal aspheric lenses.

3. United States pubmed.ncbi.nlm.nih.gov

Visual performance comparison of 2 extended depth-of-focus intraocular lenses. [2021] To compare the visual acuity and satisfaction outcomes of 2 different concepts of extended depth-of-focus intraocular lenses (EDOF IOLs).

4. United States pubmed.ncbi.nlm.nih.gov

A comparative evaluation of three extended depth of focus intraocular lenses. [2023] To compare the refractive and visual performance of three Extended Depth of Focus (EDOF) intraocular lenses (IOLs) after uncomplicated cataract surgery.

5. Germany pubmed.ncbi.nlm.nih.gov

Visual function in eyes with diffractive extended depth-of-focus and monofocal intraocular lenses: 2-year comparison. [2023] To compare long-term visual function after implantation of diffractive extended depth-of-focus (EDF) intraocular lenses (IOLs) using echelett optics and monofocal IOLs with the same platform.

6. New Zealand 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. [2022] To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Early Clinical Experience with a New Hydrophobic Acrylic Single-Piece Monofocal Intraocular Lens. [2023] To evaluate early clinical outcomes and adverse events (AEs) in cataract patients following implantation of a monofocal hydrophobic acrylic IOL with a new optimized non-constant aberration-correcting design (CT LUCIA 621P).

8. United States pubmed.ncbi.nlm.nih.gov

European, Multicenter, Prospective, Non-comparative Clinical Evaluation of an Extended Depth of Focus Intraocular Lens. [2021] To evaluate clinical and safety results obtained with an extended depth of focus (EDOF) intraocular lens (IOL).

9. United States 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. [2023] Extended depth-of-focus (EDOF) intraocular lenses (IOLs) provide a continuous range of uncorrected vision at different distances.

10. United States pubmed.ncbi.nlm.nih.gov

Through-Focus Response of Extended Depth of Focus Intraocular Lenses. [2022] To investigate extended depth of focus intraocular lenses (EDOF IOLs), intended to extend the depth of field after cataract surgery in a comparative study at the optical bench.