Clareon PanOptix Lenses for Cataracts

Recruiting at 4 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Monovision correction, Previous eye surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 2 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and performance of two special lenses, Clareon PanOptix Pro/Pro Toric IOL, for individuals needing cataract surgery in both eyes. These lenses improve vision for distant, intermediate, and near objects. The trial seeks participants with cataracts in both eyes who plan to undergo routine surgery. Participants must attend all study visits and sign a consent form. As an unphased trial, this study provides a unique opportunity to contribute to advancements in cataract treatment technology.

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 intraocular lenses are safe for cataract surgery?

Research shows that the Clareon PanOptix Pro/Pro Toric lenses are generally safe and well-tolerated by patients. Their approval for use indicates a strong safety record. Studies have found that these lenses improve vision at various distances, such as far away, at arm's length, and up close. However, they should not be used if certain eye conditions exist, like a tear in the back part of the eye's lens capsule or damage to the fibers holding the lens in place. Overall, the safety data supports using these lenses in cataract surgery, but individual health conditions should be considered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clareon PanOptix Pro/Pro Toric IOL lenses because they offer a trifocal solution designed to improve vision at multiple distances for cataract patients. Unlike traditional monofocal lenses that only enhance vision at one distance, these lenses aim to eliminate the need for glasses by providing clear vision close-up, at intermediate distances, and far away. Additionally, the PanOptix Pro Toric version addresses astigmatism, which is a common issue that affects vision clarity. This innovative approach could significantly enhance the quality of life for people with cataracts by reducing their dependence on corrective eyewear.

What evidence suggests that the Clareon PanOptix Lenses are effective for cataracts?

Research shows that the Clareon PanOptix Pro/Pro Toric lenses, studied in this trial, are designed to improve vision at various distances, including far away, at arm's length, and up close. These lenses aim to help individuals see clearly without glasses after cataract surgery. Although specific data on the Clareon version is limited, similar lenses have shown promising results. For instance, studies have found that many patients experience excellent vision quality, which makes everyday tasks easier. Overall, these lenses could potentially enhance vision for those undergoing cataract surgery. ^{1 2 4 5 6}

Who Is on the Research Team?

Sr. Principal Clinical Trial Operations, Surgical

Principal Investigator

Alcon Research LLC

Are You a Good Fit for This Trial?

This trial is for individuals with cataracts in both eyes who need routine surgery and are willing to attend all study visits. They must understand and sign a consent form. People with certain eye conditions, previous eye surgeries, or those wanting monovision correction cannot participate.

Inclusion Criteria

Subject must be able to understand and sign an approved informed consent form

Other protocol-defined inclusion criteria may apply

I have cataracts in both eyes and plan to have them removed.

Exclusion Criteria

Ocular conditions as specified in the protocol

Other protocol-defined exclusion criteria may apply

I want correction for seeing clearly at one distance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery in both eyes, with the second eye surgery occurring within 7 to 14 days of the first. The clouded lens will be removed by phacoemulsification, and the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visual acuity assessments at Month 1 and Month 6 postoperative.

6 months

7 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clareon PanOptix Pro/Pro Toric IOL

Trial Overview

The trial is evaluating the safety and performance of two approved intraocular lenses (IOLs), Clareon PanOptix Pro and Pro Toric Trifocal IOLs, designed to improve vision at various distances after cataract removal by phacoemulsification.

How Is the Trial Designed?

Group I: Clareon PanOptix Pro/Pro Toric Trifocal IOL Experimental Treatment 2 Interventions

The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

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

Citations

1.

myalcon.com

myalcon.com/cataracts/clareon-iols/panoptix-pro/

Clareon® PanOptix® Pro Trifocal and Trifocal Toric IOL

Designed to offer clear, uninterrupted vision. Whether at work, or at play, the advanced Clareon® PanOptix® Pro cataract replacement lens empowers you to see ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07161635

Post Market Clinical Evaluation of Clareon PanOptix Pro ...

Study Plan ; Experimental : Clareon PanOptix Pro/Pro Toric Trifocal IOL. The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11495208/

The Clareon Vs AcrySof PanOptix Trifocal IOL

Significantly more AcrySof (66%) than Clareon (42%) patients achieved a spherical equivalent outcome within 0.25 D of target. Best corrected ...

4.

ajo.com

ajo.com/article/S0002-9394(24)00351-9/pdf

Functional Outcomes After Refractive Lens Exchange With ...

There is as yet scarce clinical data on the Clareon. PanOptix IOL, as it is relatively new. Lee et al. retrospec- tively examined outcomes after ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06401551

Study Details | NCT06401551 | Clareon PanOptix Pro vs. ...

The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity. Other ...

6.

myalcon.com

myalcon.com/professional/cataract-surgery/iols/clareon-panoptix-pro/

Clareon® PanOptix® Pro Trifocal IOL | Alcon Professional US

For the Clareon® PanOptix® Pro Toric Trifocal IOLs, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a ...