enVista Trifocal Intraocular Lenses for Cataracts

No longer recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new trifocal lens, the enVista MX60EFH trifocal intraocular lenses (IOLs), used during cataract surgery to improve vision at various distances. The study compares this trifocal lens to a standard single-focus lens, the enVista MX60E monofocal intraocular lenses (IOLs), to determine which performs better. Individuals with cataracts affecting their vision and planning cataract surgery might be suitable for this trial. If cataracts make everyday tasks like reading or driving difficult, this trial may be relevant. As an unphased trial, it offers an opportunity to contribute to the understanding of new lens technologies for cataract surgery.

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 prior data suggests that these intraocular lenses are safe?

Research has shown that the enVista trifocal intraocular lens (IOL) is generally well-tolerated. These lenses help people see clearly at different distances. In past studies, many patients needed glasses less often, indicating the lens works effectively.

Safety data from earlier studies revealed that most patients did not experience serious problems. Some common side effects were mild, such as seeing glare or halos around lights, especially at night. These side effects are typical for this type of lens and usually lessen over time.

It is important to know that clinical trials are testing this lens for cataract surgery. Trials for new treatments focus heavily on safety, so researchers closely monitor and manage any serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the enVista MX60EFH trifocal intraocular lens (IOL) because it offers a unique approach to improving vision after cataract surgery. Unlike standard monofocal lenses that only enhance vision at one distance, this trifocal lens is designed to provide clear vision at near, intermediate, and far distances, reducing the need for additional glasses or contact lenses. Its hydrophobic acrylic material also helps reduce the risk of clouding over time, maintaining clear vision for longer. This multifaceted design could significantly enhance the quality of life for patients by offering a broader range of vision correction in a single lens.

What evidence suggests that these intraocular lenses are effective for vision improvement?

Studies have shown that the enVista trifocal intraocular lens (IOL), which participants in this trial may receive, can improve vision at various distances for people with cataracts. Nearly 93% of patients reported satisfaction with their near vision after receiving this lens. This trifocal IOL replaces the eye's natural lens and provides clear vision for near, far, and intermediate distances. Research indicates that this lens effectively offers a full range of vision, which greatly aids in everyday activities. ^{1 2 3 4 5}

Who Is on the Research Team?

Anya Loncaric

Principal Investigator

Bausch & Lomb Incorporated

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

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

Citations

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) As demonstrated in Table 21, 4-6 months after surgery, results show a trend of more subjects who received this lens (enVista Trifocal IOL) ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/55/NCT04224155/Prot_SAP_000.pdf

Protocol #900 The enVista® MX60EFH trifocal IOL is a 1-piece hydrophobic acrylic ultraviolet-absorbing intraocular lens intended to replace the natural ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447810/

Efficacy and safety evaluation of a new full visual range vs ... Overall, 93% of patients implanted with the FVR IOL were satisfied (completely to moderately satisfied) with their postoperative near vision compared with 56% ...

4. withpower.com withpower.com/trial/phase-cataract-2-2020-20b53

Clinical Study to Evaluate the Safety and Performance of ... 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 ...

5. ctv.veeva.com ctv.veeva.com/study/clinical-study-to-evaluate-the-safety-and-performance-of-the-envista-r-one-piece-hydrophobic-acrylic

Clinical Study to Evaluate the Safety and Performance of the ... The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular ...