New Lens Implant for Cataract Surgery

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: 2-4 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, Surgical

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

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

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)

Treatment Details

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.

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 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