120 Participants Needed

Clareon PanOptix Lenses for Cataracts

Recruiting at 4 trial locations
AC
Overseen ByAlcon Call Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Alcon Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12456

Who Is on the Research Team?

SP

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.
See 1 more

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.
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: Clareon PanOptix Pro/Pro Toric Trifocal IOLExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

Clareon® PanOptix® Pro Trifocal and Trifocal Toric IOLDesigned to offer clear, uninterrupted vision. Whether at work, or at play, the advanced Clareon® PanOptix® Pro cataract replacement lens empowers you to see ...
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 ...
The Clareon Vs AcrySof PanOptix Trifocal IOLSignificantly more AcrySof (66%) than Clareon (42%) patients achieved a spherical equivalent outcome within 0.25 D of target. Best corrected ...
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 ...
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 ...
Clareon® PanOptix® Pro Trifocal IOL | Alcon Professional USFor 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 ...
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