New Lens for Cataracts

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

161 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

Research Team

Principal Clinical Trial Lead

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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