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NCT06041139

Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Completed Results posted Last updated 23 May 2025
What this trial tests

trial testing Visual Acuity in Pseudophakia in 230 participants. Completed in 16 April 2024.

Timeline
12 September 2022
Primary endpoint
16 April 2024
16 April 2024

Quick facts

Lead sponsorBerkeley Eye Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment230
Start date12 September 2022
Primary completion16 April 2024
Estimated completion16 April 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Berkeley Eye Center — full company profile →

Who can join

40 and older, any sex, with Pseudophakia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm Primary · 3 months post operatively

Binocular DCNVA Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix0.03± 0.08
Johnson & Johnson Synergy0.01± 0.07
Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m. Secondary · 3 months post operatively

Binocular CDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix-0.06± 0.06
Johnson & Johnson Synergy-0.07± 0.07
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm. Secondary · 3 months post operatively

Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix0.00± 0.08
Johnson & Johnson Synergy0.00± 0.07
Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m. Secondary · 3 months post operatively

Binocular UDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix-0.01± 0.08
Johnson & Johnson Synergy0.00± 0.08
Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm. Secondary · 3 months post operatively

Binocular UIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix0.00± 0.08
Johnson & Johnson Synergy0.00± 0.08
Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm. Secondary · 3 months post operatively

Binocular UNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix0.03± 0.08
Johnson & Johnson Synergy0.03± 0.08
Binocular Target Corrected Defocus Curve Secondary · 3 months post operatively

Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

-3.00 D
GroupValue95% CI
Alcon PanOptix0.12± 0.09
Johnson & Johnson Synergy0.09± 0.09
-2.50 D
GroupValue95% CI
Alcon PanOptix0.03± 0.08
Johnson & Johnson Synergy0.03± 0.09
-2.00 D
GroupValue95% CI
Alcon PanOptix-0.01± 0.08
Johnson & Johnson Synergy0.01± 0.09
-1.50 D
GroupValue95% CI
Alcon PanOptix0.02± 0.09
Johnson & Johnson Synergy0.02± 0.09
-1.00 D
GroupValue95% CI
Alcon PanOptix0.10± 0.09
Johnson & Johnson Synergy0.06± 0.09
-0.50 D
GroupValue95% CI
Alcon PanOptix0.06± 0.07
Johnson & Johnson Synergy0.03± 0.07
-0.25 D
GroupValue95% CI
Alcon PanOptix-0.02± 0.07
Johnson & Johnson Synergy-0.04± 0.06
0.00 D
GroupValue95% CI
Alcon PanOptix-0.07± 0.07
Johnson & Johnson Synergy-0.06± 0.06
Patient Reported Satisfaction by IOLSAT Questionnaire. Secondary · 3 months post operatively

Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage.

GroupValue95% CI
Alcon PanOptix89
Johnson & Johnson Synergy94
Patient Reported Dysphotopsias Questionnaire (QUVID). Secondary · 3 months post operatively

Patient reported disphotopsias by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of subjects that answered "Never" for frequency are provided.

Starbursts
GroupValue95% CI
Alcon PanOptix65
Johnson & Johnson Synergy49
Halos
GroupValue95% CI
Alcon PanOptix38
Johnson & Johnson Synergy38
Glare
GroupValue95% CI
Alcon PanOptix48
Johnson & Johnson Synergy55
Haze
GroupValue95% CI
Alcon PanOptix84
Johnson & Johnson Synergy86
Blurred Vision
GroupValue95% CI
Alcon PanOptix87
Johnson & Johnson Synergy75
Double Vision
GroupValue95% CI
Alcon PanOptix97
Johnson & Johnson Synergy100
Dark Area
GroupValue95% CI
Alcon PanOptix98
Johnson & Johnson Synergy96
Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE). Secondary · 3 months post operatively

Post operative refraction. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix0.24± 0.26
Johnson & Johnson Synergy0.23± 0.26
Spectacle Independence Utilizing the IOLSAT. Secondary · 3 months post operatively

Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".

Overall
GroupValue95% CI
Alcon PanOptix92
Johnson & Johnson Synergy97
Distance
GroupValue95% CI
Alcon PanOptix99
Johnson & Johnson Synergy100
Intermediate
GroupValue95% CI
Alcon PanOptix99
Johnson & Johnson Synergy100
Near
GroupValue95% CI
Alcon PanOptix93
Johnson & Johnson Synergy96
Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm. Secondary · 3 months post operatively

Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.

GroupValue95% CI
Alcon PanOptix0.09± 0.09
Johnson & Johnson Synergy0.04± 0.08

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Visual Outcomes and Patient Satisfaction of Two Continuous Range of Vision Intraocular Lenses.
    Micheletti JM, Hall B, Smiley HG, Langston WJ. · · 2025 · cited 2× · PMID 39896313 · DOI 10.2147/opth.s504090

Verify or expand the search:

Other trials of Visual Acuity

Trials testing the same drug.

Other recruiting trials for Pseudophakia

Currently open trials in the same condition.

Other Berkeley Eye Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06041139.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing