Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction

Recruiting at 9 trial locations

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Alpha blockers

Disqualifiers: Corneal pathology, Glaucoma, Retinal detachment, Diabetic retinopathy, others

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

Compensation: Varies

Number of Visits: 4

Duration: Immediate post-operative period

165 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new type of eye lens called the enVista trifocal intraocular lens. It is designed to help people see clearly at different distances after being implanted in the eye. The study focuses on patients who need a lens replacement, often due to cataracts.

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

The trial protocol does not specify if you need to stop taking your current medications, but it does exclude those using drugs that interfere with visual performance or have used certain medications like Flomax® within 30 days of enrollment.

What data supports the effectiveness of the enVista MX60EFH trifocal intraocular lenses (IOLs) and enVista MX60E monofocal intraocular lenses (IOLs) treatment?

Research on similar trifocal intraocular lenses shows that they can improve vision and reduce the need for glasses after cataract surgery, leading to high patient satisfaction and better quality of life. ^{1 2 3 4 5}

Is the enVista MX60EFH trifocal intraocular lens safe for humans?

Research on trifocal intraocular lenses, including studies in Japan and other locations, shows they are generally safe for use in humans after cataract surgery, with no major safety concerns reported. ^{1 6 7 8 9}

How does the enVista MX60EFH trifocal intraocular lens treatment differ from other treatments for vision correction?

The enVista MX60EFH trifocal intraocular lens is unique because it is designed to provide clear vision at multiple distances (near, intermediate, and far) after cataract surgery, unlike traditional lenses that may only focus on one or two distances. This trifocal design aims to reduce the need for glasses or contact lenses after surgery. ^{1 9 10 11 12}

Research Team

Anya Loncaric

Principal Investigator

Bausch & Lomb Incorporated

Eligibility Criteria

Inclusion Criteria

Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.

Subjects must have a Best-corrected Distance Visual Acuity (CDVA) equal to or worse than 20/40 in at least one eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.

Subjects must have a Best-corrected Distance Visual Acuity (CDVA) projected to be equal to or better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract extraction and receive the enVista trifocal intraocular lens implantation

Immediate post-operative period

Surgery and immediate post-operative visits

Follow-up

Participants are monitored for safety and performance of the intraocular lens, including visual acuity and adverse events

24-26 weeks

Multiple visits up to Post-Operative Visit 4 (Day 120 to Day 180)

Treatment Details

Interventions

• enVista MX60EFH trifocal intraocular lenses (IOLs)
• enVista MX60E monofocal intraocular lenses (IOLs)

Participant Groups

Group I: enVista MX60EFH trifocal intraocular lens (IOL) Experimental Treatment 1 Intervention

Group II: enVista MX60E monofocal intraocular lens (IOL) Active Control 1 Intervention

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

References

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

Clinical Outcomes and Patient Satisfaction with a New Diffractive-Refractive Trifocal Intraocular Lens - A 12 Month Prospective Study. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Visual Outcomes, Patient Satisfaction and Spectacle Independence with a Trifocal Diffractive Intraocular Lens. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Objective and subjective results following implantation of the FineVision trifocal intraocular lens in Mexican patients. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Visual outcomes after bilateral trifocal diffractive intraocular lens implantation. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Visual and subjective outcomes following trifocal intraocular lens implantation in Iranian cataractous patients. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Diffractive trifocal pseudophakic intraocular lenses in high myopic eyes: 2-year assessment after implantation. [2020]

7. Japan pubmed.ncbi.nlm.nih.gov

Results of a clinical evaluation of a trifocal intraocular lens in Japan. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Initial results of trifocal diffractive IOL implantation. [2022]

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

Clinical outcomes with a trifocal intraocular lens: a multicenter study. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

A comparative clinical study of the visual results between three types of multifocal lenses. [2022]

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

Optical bench performance of 3 trifocal intraocular lenses. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Early clinical evaluation of AcrySof ReSTOR multifocal intraocular lens for treatment of cataract. [2019]