What side effects are associated with this type of intervention?

The most common treatments for astigmatism using intraocular lenses (IOLs) like Clareon Vivity, Vivity Toric, Clareon PanOptix, and PanOptix Toric include potential side effects such as glare, halos, and starbursts around lights, particularly at night. Some patients may experience reduced contrast sensitivity and difficulty with night vision. There is also a risk of developing posterior capsule opacification (a clouding of the lens capsule), which may require a follow-up laser procedure to correct. Additionally, some patients might experience dry eye symptoms or discomfort following the surgery.

What prior FDA approvals exist?

The FDA has approved several intraocular lenses (IOLs) for the treatment of astigmatism, particularly those that offer extended depth of focus and multifocal capabilities. Notable examples include the Clareon Vivity and Vivity Toric IOLs, which provide extended depth of focus, and the Clareon PanOptix and PanOptix Toric IOLs, which are multifocal lenses designed to improve vision at multiple distances. These lenses are part of a broader category of advanced IOLs that aim to enhance visual outcomes for patients with astigmatism and other refractive errors.

What other types of research exist?

Promising novel alternatives to Clareon Vivity, Vivity Toric, Clareon PanOptix, and PanOptix Toric IOLs for astigmatism patients in 2024 include: 1. Synergy and Synergy Toric IOLs by Johnson & Johnson Vision, which combine EDOF and multifocal technologies for improved visual outcomes. 2. Alcon's AcrySof IQ Vivity IOL, which offers non-diffractive EDOF technology and is designed to provide a continuous range of vision. 3. TECNIS Symfony and Symfony Toric IOLs by Johnson & Johnson Vision, which provide EDOF and are known for their ability to correct astigmatism while offering a broad range of vision.

← Back to Search

Intraocular Lens

IOL Implants for Vision Improvement

N/A

Recruiting

Research Sponsored by Alcon Research

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 up to year 3

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the safety and performance of special artificial lenses used in cataract surgery. The study focuses on patients who have already received these lenses. These lenses help improve vision by replacing the eye's cloudy natural lens and focusing light correctly onto the retina.

Who is the study for?

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.

What is being tested?

The trial aims to assess the long-term safety and effectiveness of two types of intraocular lenses: Clareon Vivity and PanOptix, including versions designed for astigmatism (Toric). It's a follow-up study focusing on patients who already received these implants.

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with intraocular lens implants can include visual disturbances like glare and halos, eye inflammation or infection, bleeding inside the eye, increased eye pressure, and retinal detachment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 3 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit

Rate of Adverse Events

Rate of Device Deficiencies

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Clareon Vivity IOL - ToricExperimental Treatment1 Intervention

Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL.

Group II: Clareon Vivity IOL - Non ToricExperimental Treatment1 Intervention

Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL.

Group III: Clareon PanOptix IOL - ToricExperimental Treatment1 Intervention

Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL.

Group IV: Clareon PanOptix IOL - Non ToricExperimental Treatment1 Intervention

Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL.

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

The most common treatments for astigmatism, particularly those involving Extended Depth of Focus (EDOF) and Multifocal Intraocular Lenses (IOLs) like Clareon Vivity, Vivity Toric, Clareon PanOptix, and PanOptix Toric, work by correcting the irregular curvature of the cornea or lens that causes blurred vision. EDOF lenses extend the range of clear vision, reducing dependency on glasses by providing a continuous range of focus from near to far distances. Multifocal lenses, on the other hand, have multiple zones for different focal points, allowing for clear vision at various distances. These mechanisms are crucial for astigmatism patients as they address the specific refractive errors, improving overall visual acuity and quality of life by reducing the need for corrective eyewear.