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CompletedNCT06041139Updated May 23, 2025Results posted

Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

An observational study in Pseudophakia, sponsored by Berkeley Eye Center. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Berkeley Eye Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
230
Ages
40 Years and older
Sex
All
01

Study 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.
Read the detailed description
  • This is a non-interventional single center, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery.
  • There will be 155 subjects enrolled in each arm (310 subjects total).
  • Consecutive screening will be used for enrollment beginning from the first bilateral IOL implanted.
  • All testing will be at a single site with subjects coming from 4 surgeons (all use similar surgical technique) at that site.
  • Each surgeon will contribute a minimum of ten subjects per arm.
  • Subjects will be assessed post-operatively during a minimum of five months after their second-eye surgery.
  • Binocular defocus curves will be performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
  • Self-reporting of visual complaints will be assessed.
  • IOLSAT (IOL Satisfaction) and QUVID (Quality of Vision After Surgery) questionnaire will be administered at the study visit.
  • Halo and Glare simulator VS Halo \& Glare (visu-med.com) will be administered at the study visit.
  • All visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked.
  • PanOptix subjects will have been implanted with the toric and non-toric models.
  • Synergy subjects will have been implanted with the toric and non-toric models.
  • Demographic data will be collected to match the groups as closely as possible.
02

Conditions studied

  • Pseudophakia

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Keywords

  • Pseudophakia
  • Alcon PanOptix
  • Johnson & Johnson Tecnis Synergy
03

In context

Pseudophakia

54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.

This study's enrollment of 230 is above the median of 71 across 26 observational studies indexed under Pseudophakia.

Browse Pseudophakia studies →

Lead sponsor

Berkeley Eye Center is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with healthy eyes and uncomplicated bilateral implantation of Panoptix IOLs or Synergy IOLs.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Are willing and able to understand and sign an
  • Are willing and able to complete all required study visits
  • Are more than 40 years of age
  • Patient diagnosed with cataracts both eyes and underwent uncomplicated cataract surgeries
  • Patients with bilateral PanOptix (toric or non-toric)
  • Patients with bilateral Synergy (toric or non-toric)
  • Post-op best Corrected distance Visual Acuity for each eye is logMAR 0.1 (20/25) or better after cataract removal.
  • Post-op residual refractive error +0.50 - -0.50 SE with ≤ 0.75 residual refractive astigmatism in each eye
  • Minimum of two weeks post Yttrium Aluminum Garnet capsulotomy to treat posterior capsular opacification

Exclusion criteria

Exclusion Criteria:

  • Corneal dystrophies or degenerations
  • Failure to return for follow up at designed intervals.
  • Any conditions that might affect cataract removal (pseudoexfoliation, posterior polar cataract, Flomax, etc.)
  • Any conditions during surgery that might prolong the cataract removal (capsular tear, inadequate pupil dilation, etc.)
  • Strabismus with or without amblyopia in either eye
  • Previous ocular surgery of any kind
  • History of retinal detachment
  • Any corneal abnormality, other than regular corneal astigmatism (as determined by corneal topography) that in the opinion of the investigator would confound the outcome(s) of the study
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that in the opinion of the investigator is
  • Subjects with glaucoma
  • Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g. , connective tissue disease, clinically significant atopic disease, diabetes, etc)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
230 participants (actual)
Patient registry
No

Groups and cohorts

  • Alcon PanOptix

    Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.

    Diagnostic Test: Visual Acuity · Diagnostic Test: Defocus Curve · Diagnostic Test: Halo and Glare testing · Other: Patient Questionnaires

  • Johnson & Johnson Synergy

    Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.

    Diagnostic Test: Visual Acuity · Diagnostic Test: Defocus Curve · Diagnostic Test: Halo and Glare testing · Other: Patient Questionnaires

Interventions

  • Diagnostic testVisual Acuity

    Measurement of distance, intermediate and near visual acuity.

  • Diagnostic testDefocus Curve

    Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.

  • Diagnostic testHalo and Glare testing

    Measurement to quantify degree of visual loss caused by either halo and/or glare.

    Also known as: VS Halo & Glare (visu-med.com)

  • OtherPatient Questionnaires

    Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.

    Also known as: IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire

06

What researchers measure

Primary outcomes

  1. Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm

    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.

    Time frame: 3 months post operatively

Secondary outcomes

  1. Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.

    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.

    Time frame: 3 months post operatively

  2. Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.

    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.

    Time frame: 3 months post operatively

  3. Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.

    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.

    Time frame: 3 months post operatively

  4. Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.

    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.

    Time frame: 3 months post operatively

  5. Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.

    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.

    Time frame: 3 months post operatively

  6. Binocular Target Corrected Defocus Curve

    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.

    Time frame: 3 months post operatively

  7. Patient Reported Satisfaction by IOLSAT Questionnaire.

    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.

    Time frame: 3 months post operatively

  8. Patient Reported Dysphotopsias Questionnaire (QUVID).

    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.

    Time frame: 3 months post operatively

  9. Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).

    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.

    Time frame: 3 months post operatively

Other outcomes

  1. Spectacle Independence Utilizing the IOLSAT.

    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".

    Time frame: 3 months post operatively

  2. Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.

    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.

    Time frame: 3 months post operatively

07

Results

Posted May 23, 2025

Participant flow

Participant flow — Overall Study
MilestoneAlcon PanOptixJohnson & Johnson Synergy
Started15377
Completed15377
Not completed00

Outcome measures

PrimaryBinocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm
logMARAlcon PanOptixJohnson & Johnson Synergy
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm0.03 ± 0.080.01 ± 0.07
SecondaryBinocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.
logMARAlcon PanOptixJohnson & Johnson Synergy
Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.-0.06 ± 0.06-0.07 ± 0.07
SecondaryBinocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.
logMARAlcon PanOptixJohnson & Johnson Synergy
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.0.00 ± 0.080.00 ± 0.07
SecondaryBinocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.
logMARAlcon PanOptixJohnson & Johnson Synergy
Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.-0.01 ± 0.080.00 ± 0.08
SecondaryBinocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.
logMARAlcon PanOptixJohnson & Johnson Synergy
Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.0.00 ± 0.080.00 ± 0.08
SecondaryBinocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.
logMARAlcon PanOptixJohnson & Johnson Synergy
Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.0.03 ± 0.080.03 ± 0.08
SecondaryBinocular Target Corrected Defocus Curve

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular Target Corrected Defocus Curve
logMARAlcon PanOptixJohnson & Johnson Synergy
-3.00 D0.12 ± 0.090.09 ± 0.09
-2.50 D0.03 ± 0.080.03 ± 0.09
-2.00 D-0.01 ± 0.080.01 ± 0.09
-1.50 D0.02 ± 0.090.02 ± 0.09
-1.00 D0.10 ± 0.090.06 ± 0.09
-0.50 D0.06 ± 0.070.03 ± 0.07
-0.25 D-0.02 ± 0.07-0.04 ± 0.06
0.00 D-0.07 ± 0.07-0.06 ± 0.06
0.25 D-0.03 ± 0.07-0.01 ± 0.08
0.50 D0.04 ± 0.070.04 ± 0.09
1.00 D0.22 ± 0.100.21 ± 0.11
SecondaryPatient Reported Satisfaction by IOLSAT Questionnaire.

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.

Time frame:
3 months post operatively
Reported as:
Number · percentage of participants
Patient Reported Satisfaction by IOLSAT Questionnaire.
percentage of participantsAlcon PanOptixJohnson & Johnson Synergy
Patient Reported Satisfaction by IOLSAT Questionnaire.8994
SecondaryPatient Reported Dysphotopsias Questionnaire (QUVID).

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.

Time frame:
3 months post operatively
Reported as:
Number · percentage of participants
Patient Reported Dysphotopsias Questionnaire (QUVID).
percentage of participantsAlcon PanOptixJohnson & Johnson Synergy
Starbursts6549
Halos3838
Glare4855
Haze8486
Blurred Vision8775
Double Vision97100
Dark Area9896
SecondaryPost Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).

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.

Time frame:
3 months post operatively
Reported as:
Mean · D
Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).
DAlcon PanOptixJohnson & Johnson Synergy
Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).0.24 ± 0.260.23 ± 0.26
Other pre-specifiedSpectacle Independence Utilizing the IOLSAT.

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".

Time frame:
3 months post operatively
Reported as:
Number · percentage of participants
Spectacle Independence Utilizing the IOLSAT.
percentage of participantsAlcon PanOptixJohnson & Johnson Synergy
Overall9297
Distance99100
Intermediate99100
Near9396
Other pre-specifiedBinocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.

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.

Time frame:
3 months post operatively
Reported as:
Mean · logMAR
Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.
logMARAlcon PanOptixJohnson & Johnson Synergy
Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.0.09 ± 0.090.04 ± 0.08

Adverse events

Collected over 3 months postoperatively. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alcon PanOptix0/153 (0%)0/153 (0%)0/153 (0%)
Johnson & Johnson Synergy0/77 (0%)0/77 (0%)0/77 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Alcon PanOptixJohnson & Johnson SynergyTotal
Mean65.6 ± 8.365.9 ± 10.265.7 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)Alcon PanOptixJohnson & Johnson SynergyTotal
Female8751138
Male662692
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Alcon PanOptixJohnson & Johnson SynergyTotal
Count of participants——0
08

Study locations

1 site
  • Berkeley Eye Center
    Houston, Texas 77027, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Apr 2024, 19 months.

Results were first posted in May 2025, 1 year 1 month after primary completion.

Of 16 observational studies under Pseudophakia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 19 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2022
First posted
Sep 18, 2023
StartActual
Sep 12, 2022
Primary completionActual
Apr 16, 2024
CompletionActual
Apr 16, 2024
Results first posted
May 23, 2025
Last update
May 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06041139
Lead sponsor
Berkeley Eye Center
Responsible party
Sponsor
First posted
Sep 18, 2023
Start date
Sep 12, 2022
Primary completion
Apr 16, 2024
Completion
Apr 16, 2024
Results posted
May 23, 2025
Last update
May 23, 2025

Study contacts

Morgan Micheletti, MD
principal investigator · Berkeley Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

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