IOL Implants for Vision Improvement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the long-term effectiveness of certain lens implants in improving vision. Specifically, it examines Clareon Vivity and PanOptix lenses, types of intraocular lenses (IOLs), in individuals who received them in both eyes a few months ago. It is ideal for those who had these specific lenses implanted in both eyes within the last 3-6 months and have a documented history of eye issues. By joining, participants assist researchers in understanding the safety and performance of these lenses. As an unphased trial, this study allows participants to contribute to valuable research that could enhance vision care for many.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these IOL implants are safe for vision improvement?
Research has shown that the Clareon PanOptix and Clareon Vivity lenses are generally well-received by patients. The Clareon PanOptix lens, which aids in seeing at different distances, provides good vision with few issues like glare or halos, common with some other lenses.
For the Clareon Vivity lens, studies suggest it offers clear vision at various distances with even fewer side effects. This lens provides a wider range of vision without the usual problems associated with lenses that assist with multiple distances, such as visual disturbances. These lenses have a strong safety record, having passed the necessary tests for approval and use in the eye.
Overall, these lenses have demonstrated promising results in terms of safety and effectiveness in improving vision.12345Why are researchers excited about this trial?
Researchers are excited about the Clareon PanOptix and Clareon Vivity intraocular lenses (IOLs) because they offer innovative ways to improve vision after cataract surgery. Unlike standard monofocal lenses that only enhance vision at one distance, the Clareon PanOptix Trifocal IOL provides clear vision across multiple distances, which can reduce the need for glasses. The Clareon Vivity IOL, on the other hand, uses a non-diffractive technology to extend the range of vision, offering a smoother transition between near and distant vision without some of the side effects associated with traditional multifocal lenses. Additionally, the toric versions of these lenses are designed to correct astigmatism, making them versatile solutions for various vision correction needs.
What is the effectiveness track record for Clareon Vivity and PanOptix IOLs in vision improvement?
This trial will compare different IOL implants for vision improvement. Research has shown that the Clareon PanOptix Trifocal IOL, which participants in this trial may receive, significantly improves vision quality and reduces the need for glasses. Studies have found it enhances vision at various distances, with many patients feeling satisfied and experiencing fewer side effects. Similarly, the Clareon PanOptix Trifocal Toric IOL, another option in this trial, effectively provides clear and stable vision for people with astigmatism.
For the Clareon Vivity IOL, also studied in this trial, research highlights its ability to improve focus, enhancing both distance and middle-range vision. It helps reduce the need for reading glasses, although there might be a slight decrease in contrast compared to standard lenses. The Clareon Vivity Toric IOL, another treatment arm in this trial, offers similar benefits for those with astigmatism, providing clear and lasting vision improvements.14678Who Is on the Research Team?
Clinical Trial Lead, Surgical
Principal Investigator
Alcon Research, LLC
Are You a Good Fit for This Trial?
This study is for people who have had bilateral implantation of Clareon Vivity or PanOptix lenses, with or without astigmatism correction (Toric), between 3-6 months ago. Participants must be able to sign a consent form and have their medical history available. Pregnant individuals, those in other studies, or those who've had corneal surgery after lens implantation cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Retrospective Data Collection
Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment.
Prospective Follow-up
Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.
Long-term Follow-up
Participants are monitored for safety and performance of the IOLs over a long-term period.
What Are the Treatments Tested in This Trial?
Interventions
- Clareon PanOptix Trifocal IOL - Non Toric
- Clareon PanOptix Trifocal IOL - Toric
- Clareon Vivity IOL - Non Toric
- Clareon Vivity IOL - Toric
Clareon PanOptix Trifocal IOL - Non Toric is already approved in United States, European Union for the following indications:
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Who Is Running the Clinical Trial?
Alcon Research
Lead Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California