enVista Trifocal Intraocular Lenses for Cataracts
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.12345Why 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.12345
Who Is on the Research Team?
Anya Loncaric
Principal Investigator
Bausch & Lomb Incorporated
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cataract extraction and receive the enVista trifocal intraocular lens implantation
Follow-up
Participants are monitored for safety and performance of the intraocular lens, including visual acuity and adverse events
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?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bausch & Lomb Incorporated
Lead Sponsor
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
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) ...
Protocol #900
The enVista® MX60EFH trifocal IOL is a 1-piece hydrophobic acrylic ultraviolet-absorbing intraocular lens intended to replace the natural ...
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% ...
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-acrylicClinical 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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.