New Lens for Cataracts

No longer recruiting at 7 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Pregnancy, Breastfeeding, Monovision, others

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

Compensation: Varies

Number of Visits: 9

Duration: 2-3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of lenses, Clareon PanOptix and Clareon PanOptix Pro, used in cataract surgery to determine which is safer and more effective. Cataracts can cloud vision, and these new lenses aim to improve sight after surgery. Participants will receive a lens in each eye, one type in the first eye and the other type in the second eye, about a week apart. This trial suits those planning cataract surgery on both eyes and who have mild corneal astigmatism (less than 1.00 diopter, a measure of eye curvature). As an unphased trial, it offers a unique opportunity to explore innovative lens options for clearer vision post-surgery.

Do I need to stop my current medications for the trial?

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 treatment?

A previous study showed that the Clareon PanOptix IOL is generally safe for patients. Fewer people reported visual issues like glare or halos six months after surgery compared to other lenses, suggesting that most people tolerate the lens well. Many patients were satisfied and achieved good vision without needing glasses.

The Clareon PanOptix Pro IOL is newer, so less information is available about it. It is designed to help patients see clearly at different distances, potentially reducing the need for glasses. As a new product, detailed safety data is still being gathered. However, it is based on the Clareon PanOptix technology, which is known to be safe.

Both lenses aim to improve vision and are generally considered safe based on current evidence. Participants considering the trial can feel reassured by the positive safety data for the Clareon PanOptix and the promising design of the Clareon PanOptix Pro. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Clareon PanOptix and Clareon PanOptix Pro because these innovative lens options offer potential improvements over traditional monofocal lenses used in cataract surgeries. Unlike standard monofocal lenses that provide clear vision at just one distance, these new lenses are designed to offer a range of vision, potentially reducing the need for glasses after surgery. The Clareon lenses also utilize advanced optics and materials that may enhance visual clarity and reduce issues like halos and glare, which are common with some multifocal lenses. This could lead to a significant improvement in patients' quality of life by allowing them to see well at various distances with minimal visual disturbances.

What evidence suggests that these intraocular lenses are effective for cataracts?

This trial will compare the Clareon PanOptix and Clareon PanOptix Pro lenses for cataract surgery. Research has shown that the Clareon PanOptix lenses improve vision by reducing unwanted light reflections, which can affect sight. Studies have found that these lenses provide clear vision at various distances—far, middle, and close-up. In contrast, the Clareon PanOptix Pro lenses offer even less light scatter and make better use of available light, resulting in clearer vision with fewer visual disturbances. Both lenses are promising options for enhancing vision clarity after cataract surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Principal Clinical Trial Lead

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for adults who need cataract surgery in both eyes, can follow the study schedule, and have less than 1.00 diopter of preoperative corneal astigmatism. It's not for pregnant or breastfeeding women, those wanting monovision correction, or anyone with certain eye conditions.

Inclusion Criteria

Willing and able to attend all scheduled study visits as required by the protocol

I am scheduled for cataract surgery on both eyes.

Other protocol-defined inclusion criteria may apply

Exclusion Criteria

Ocular conditions as specified in the protocol

I want to correct my vision to see clearly at different distances with each eye.

Other protocol-defined exclusion criteria may apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

CPO IOL or CPO Pro IOL is implanted in the first eye, followed by the second eye surgery 7-14 days later

2-3 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary endpoint assessed at Month 2

5 months

7 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clareon PanOptix
• Clareon PanOptix Pro

Trial Overview The study compares two types of trifocal lenses: Clareon PanOptix Pro IOL and Clareon PanOptix IOL. Participants will receive one type of lens during their planned cataract surgery to see which is safer and more effective.

How Is the Trial Designed?

Group I: CPO Pro IOL Experimental Treatment 3 Interventions

CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.

Group II: CPO IOL Experimental Treatment 3 Interventions

CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12220459/

One-year outcomes of a trifocal intraocular lens with glistening ... The Clareon PanOptix (CNWT) IOL is a newer trifocal IOL made from a glistening-free hydrophobic acrylic material incorporating hydroxyethyl ...

2. myalcon.com myalcon.com/professional/insights/clareon-panoptix-pro-expert-perspectives/

Clareon®️ PanOptix®️ Pro: Surgeons Share Early Insights 50% less light scatter, the lowest reported light scatter of any trifocal IOL. · Unprecedented 94% light utilization in trifocal IOLs, compared ...

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. alcon.com alcon.com/media-release/alcon-announces-new-cataract-surgery-outcomes-data-hosts-robust-educational-program/

Alcon Announces New Cataract Surgery Outcomes Data, ... Data from Modi demonstrates lower instances of visual disturbances at 6 months post-op in AcrySof® IQ PanOptix IOLs, when compared to TECNIS ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12345935/

Clinical and Patient-Reported Outcomes After Mix-and-Match ... Mix-and-match implantation of the Clareon PanOptix and Vivity IOLs yields good patient satisfaction potentially by combining the advantages of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002939424003519

Functional Outcomes After Refractive Lens Exchange With ... In a retrospective study of RLE patients implanted with the AcrySof IQ PanOptix Toric IOL Wallerstein et al found 87% of them achieved 20/20 binocular UDVA, ...

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

Clareon® Panoptix® IOL | Alcon Professional - MyAlcon Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample.

9. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-025-04198-2

One-year outcomes of a trifocal intraocular lens with glistening ... The new hydrophobic acrylic trifocal IOL (CNWT) with HEMA demonstrated significant improvements in visual acuity and stable refractive outcomes over one year ...