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Intraocular Lens

New Lens for Cataracts

N/A
Recruiting
Research Sponsored by Alcon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned cataract surgery (both eyes)
Be older than 18 years old
Must not have
Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 2 postoperative
Awards & highlights

Summary

This trial aims to see if a new type of lens, called Clareon™ PanOptix™ Pro Trifocal Intraocular Lens, is both safe and works well compared to the standard Clare

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include visual disturbances like glare or halos around lights, discomfort in the eye, inflammation or infection risk post-surgery. Specific side effects related to each lens type will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for cataract surgery on both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, do not plan to become pregnant, and am not breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2 postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 2 postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)

Trial Design

2Treatment groups
Experimental Treatment
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 IOLExperimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cataract Surgery
2010
Completed Phase 4
~5370

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Who is running the clinical trial?

Alcon ResearchLead Sponsor
724 Previous Clinical Trials
128,274 Total Patients Enrolled
36 Trials studying Presbyopia
6,419 Patients Enrolled for Presbyopia
Principal Clinical Trial LeadStudy DirectorAlcon Research, LLC
~45 spots leftby Feb 2025
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