New Lens Implant for Cataract Surgery

No longer recruiting at 8 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: 2-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of lens implants, Clareon™ PanOptix™ Pro and Clareon™ PanOptix™, to determine which is more effective and safer for cataract surgery patients. Cataracts cause cloudy vision, and these lens implants aim to improve sight post-surgery. The trial includes two groups: one receives the Clareon™ PanOptix™ in the first eye and the Clareon™ PanOptix™ Pro in the second eye, while the other group receives the reverse. Individuals planning cataract surgery on both eyes and having less than 1.00 diopter of corneal astigmatism (a minor curve in the eye) may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore new options for enhancing vision after cataract 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 this lens implant is safe for cataract surgery?

Research shows that the Clareon PanOptix lens is generally safe for eye surgeries. Studies have found that patients with this lens often experience stable improvements in vision over time. For instance, many report fewer issues like halos or glare six months after surgery.

The Clareon PanOptix Pro lens is newer, so less information is available. However, it is designed to provide clear vision at different distances, potentially reducing the need for glasses after surgery. While detailed safety information for this lens remains limited, it is based on the proven technology of the original PanOptix lens, which has been safely used by many patients.

In summary, the original Clareon PanOptix lens is known to be safe, and early signs for the Pro version are encouraging, though more research is needed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Clareon PanOptix and Clareon PanOptix Pro lens implants because they offer advanced technology for cataract surgery. Unlike traditional monofocal lenses, these new lenses are designed to improve vision at multiple distances—near, intermediate, and far—potentially reducing the need for glasses after surgery. Moreover, these lenses are made from a material that provides high-quality vision with reduced glare, which could enhance patient satisfaction and improve quality of life. The Clareon PanOptix Pro, in particular, is experimental and might offer even further improvements in visual outcomes.

What evidence suggests that this lens implant is effective for cataract surgery?

This trial will compare the Clareon PanOptix trifocal lens with the Clareon PanOptix Pro lens. Research has shown that the Clareon PanOptix trifocal lens is effective, allowing many to see well without glasses, with results similar to the AcrySof PanOptix lens. Patients typically experience good vision quality and few side effects. Early feedback from doctors suggests that the Clareon PanOptix Pro lens also improves vision, although less information is available about it. Both lenses in this trial aim to enhance vision after cataract surgery, helping people see both near and far without glasses. ^{6 7 8 9 10}

Who Is on the Research Team?

Principal Clinical Trial Lead, Surgical

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for adults with cataracts and presbyopia who need both eyes operated on, have less than 1.00 diopter of corneal astigmatism in each eye, can attend all visits, and aren't pregnant or breastfeeding. People with certain eye conditions or those wanting monovision correction cannot join.

Inclusion Criteria

Understand and sign an ethics committee-approved informed consent form

Preoperative corneal astigmatism less that 1.00 diopter in each eye

I am scheduled for cataract surgery on both eyes.

Exclusion Criteria

Ocular conditions as specified in the protocol

I want correction for seeing clearly at one distance.

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

Subjects undergo surgery for the implantation of Clareon PanOptix IOLs in both eyes, with the second eye surgery occurring approximately 7-14 days after the first.

2-4 weeks

2 visits (in-person) for surgeries

Follow-up

Participants are monitored for safety and effectiveness after treatment, with the primary endpoint assessed at the Month 2 follow-up visit.

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 implanted during cataract surgery: Clareon PanOptix Pro IOL versus the standard Clareon PanOptix IOL 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 Active Control 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. myalcon.com myalcon.com/professional/insights/clareon-panoptix-pro-expert-perspectives/

Clareon®️ PanOptix®️ Pro: Surgeons Share Early Insights Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07076277

Visual Outcomes in Patients Contralaterally Implanted With ... Title: Visual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro.

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

The Clareon Vs AcrySof PanOptix Trifocal IOL The Clareon PanOptix trifocal lens provides similar satisfaction and spectacle independence and has a similar side effect profile and BCVA outcome.

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

Functional Outcomes After Refractive Lens Exchange With ... A study of 27 patients (54 eyes) im- planted with the Clareon PanOptix (Alcon) multifocal in- traocular lens during ...

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

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. retrospectively examined outcomes after cataract surgery ...

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

Clinical and Patient-Reported Outcomes After Mix-and-Match ... All charts of patients who underwent routine, uncomplicated femtosecond laser-assisted cataract surgery with mix-and-match implantation of the ...

7. 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 ...

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 ... UCDVA of LogMAR 0.0 or better increased from 50.91% at 1 month to 85.95% at 12 months. CDVA of LogMAR 0.0 or better improved from 89.52% at 1 ...

10. crstoday.com crstoday.com/articles/expanding-the-clareon-iol-family/expanding-the-clareon-iol-family

Expanding the Clareon ® IOL Family The three key characteristics that I would like to highlight about the Clareon® PanOptix® IOL are its stable visual outcomes over time, its ...