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

Study Summary

This trial looks at the safety & effectiveness of IOLs for cataract surgery with mini-monovision.

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.Check my eligibility

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).See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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.

Do I qualify?Apply below to find out

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.

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Who is running the clinical trial?

Alcon ResearchIndustry Sponsor

710 Previous Clinical Trials

125,682 Total Patients Enrolled

18 Trials studying Aphakia

6,005 Patients Enrolled for Aphakia

Debbie S. Kuo, MDLead Sponsor

Media Library

Clareon Vivity and Clareon Vivity Toric (Intraocular Lens) Clinical Trial Eligibility Overview. Trial Name: NCT05821101 — N/A

Aphakia Research Study Groups: Mini-Monovision Arm

Aphakia Clinical Trial 2023: Clareon Vivity and Clareon Vivity Toric Highlights & Side Effects. Trial Name: NCT05821101 — N/A

Clareon Vivity and Clareon Vivity Toric (Intraocular Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05821101 — N/A

Aphakia Patient Testimony for trial: Trial Name: NCT05821101 — N/A

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