What side effects are associated with this type of intervention?

The most common side effects of intraocular lens (IOL) implants for treating aphakia, such as Clareon Vivity and Clareon Vivity Toric, include visual disturbances like glare, halos, and starbursts, particularly affecting night vision. Other potential complications are posterior capsule opacification, which may require a laser procedure to correct, as well as risks of infection, inflammation, and increased intraocular pressure. In rare instances, there may be dislocation or improper positioning of the lens, necessitating additional surgical intervention.

What prior FDA approvals exist?

The FDA has approved various intraocular lenses (IOLs) for the treatment of aphakia, particularly following cataract surgery. These IOLs, such as the Clareon Vivity and Clareon Vivity Toric lenses, are designed to replace the natural lens of the eye, thereby correcting vision and reducing dependency on glasses. Other similar FDA-approved IOLs include the AcrySof IQ Vivity and the Tecnis Symfony lenses, which also aim to provide a range of vision from distance to near, minimizing the need for additional corrective eyewear. These advanced IOLs represent a significant advancement in the management of aphakia, offering patients improved visual outcomes and quality of life.

What other types of research exist?

Promising alternatives to Clareon Vivity and Clareon Vivity Toric IOLs for aphakia patients in 2024 include: 1) PanOptix Trifocal IOL, which provides near, intermediate, and distance vision, reducing the need for glasses. 2) Symfony Extended Depth of Focus (EDOF) IOL, which offers a continuous range of high-quality vision. 3) Light Adjustable Lens (LAL), which allows postoperative adjustments to fine-tune vision. 4) Tecnis Synergy IOL, combining multifocal and EDOF technologies for a broader range of vision. These options aim to enhance visual outcomes and patient satisfaction post-cataract surgery.

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Intraocular Lens

Clareon Vivity IOLs with Mini-Monovision for Aphakia

N/A

Recruiting

Research Sponsored by Debbie S. Kuo, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying special lenses used in cataract surgery for patients needing surgery in both eyes. These lenses help provide clear vision at various distances. The study aims to see how well these lenses work with a mini-monovision approach, where one eye is set for distance vision and the other for near vision. Mini-monovision corrects one eye for distance vision and the other eye for near vision, providing high patient satisfaction and reduced spectacle dependence.

Who is the study for?

This trial is for adults with bilateral age-related cataracts who need both eyes operated on. They should have a potential post-op vision of 20/25 or better, require specific IOL powers, and be able to undergo two surgeries within 21 days using Clareon Vivity lenses. People with irregular astigmatism, eye diseases like glaucoma or macular degeneration, previous eye surgeries, or other conditions affecting vision are not eligible.

What is being tested?

The study is examining the effectiveness of Clareon Vivity and Clareon Vivity Toric intraocular lenses in achieving mini-monovision after cataract surgery. The dominant eye will be set for clear distance vision (emmetropia) while the non-dominant eye will be slightly nearsighted (-0.50).

What are the potential side effects?

While the description doesn't specify side effects, typical ones for similar procedures may include discomfort, redness in the eyes, temporary blurred vision or visual disturbances such as glare and halos around lights.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Binocular distance is target-corrected visual acuity (VA) at near 40cm.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mini-Monovision ArmExperimental Treatment1 Intervention

Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aphakia, the absence of the natural lens, is commonly treated with intraocular lens (IOL) implants, such as the Clareon Vivity and Clareon Vivity Toric lenses. These IOLs replace the missing lens to focus light onto the retina, correcting vision and reducing the need for glasses. This is particularly important for aphakia patients as it restores clear vision and enhances quality of life by minimizing dependence on corrective eyewear.