New Lens Implant for Cataract Surgery

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Alcon Research

No Placebo Group

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.

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.

+2 more

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

+1 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: CPO Pro IOLExperimental Treatment3 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 IOLActive Control3 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.