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Intraocular Lens
New Lens Implant for Cataract Surgery
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 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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from lens implantation may include visual disturbances like glare, halos around lights, difficulty driving at night, blurry vision, or eye discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 during the study, and am not breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 2 postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 2 postoperative
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cataract surgery
2015
N/A
~3790
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Who is running the clinical trial?
Alcon ResearchLead Sponsor
724 Previous Clinical Trials
128,274 Total Patients Enrolled
19 Trials studying Aphakia
6,166 Patients Enrolled for Aphakia
Principal Clinical Trial Lead, SurgicalStudy DirectorAlcon Research, LLC
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