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Alcon PanOptix for Pseudophakia

N/A
Recruiting
Led By Morgan Micheletti, MD
Research Sponsored by Berkeley Eye Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post operatively
Awards & highlights
No Placebo-Only Group

Summary

Background: * The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions. * A J\&J-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL. Hypothesis: * Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare, haloes, and/or starbursts. Unmet Medical Need: * There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOF/Bifocal technology in the United States.

Eligible Conditions
  • Pseudophakia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Binocular DCNVA (distance corrected near visual acuity) of Trifocal (Alcon PanOptix)
Binocular DCNVA of EDOF (extended depth of focus)/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm
Secondary study objectives
Binocular BCDVA measured at 4m.
Binocular DCIVA measured at 60cm.
Binocular UCDVA measured at 4m.
+7 more
Other study objectives
Binocular DCNVA at 33cm.
Glare will be reported.
Halo will be reported.
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Johnson & Johnson SynergyExperimental Treatment4 Interventions
Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Group II: Alcon PanOptixExperimental Treatment4 Interventions
Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Visual Acuity
2022
N/A
~450
Defocus Curve
2021
N/A
~320

Find a Location

Who is running the clinical trial?

Berkeley Eye CenterLead Sponsor
4 Previous Clinical Trials
693 Total Patients Enrolled
3 Trials studying Pseudophakia
486 Patients Enrolled for Pseudophakia
Morgan Micheletti, MDPrincipal InvestigatorBerkeley Eye Center
4 Previous Clinical Trials
693 Total Patients Enrolled
3 Trials studying Pseudophakia
486 Patients Enrolled for Pseudophakia
~0 spots leftby Dec 2024