PseudophakiaNCT06041139
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
An observational study of Pseudophakia, run by Berkeley Eye Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudophakia
- What is being tested?
- Visual Acuity, Defocus Curve and Halo and Glare testing
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 16 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with healthy eyes and uncomplicated bilateral implantation of Panoptix IOLs or Synergy IOLs.
Who may be able to join
- Are willing and able to understand and sign an informed consent
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 clinically significant
- Subjects with glaucoma
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, etc)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Pseudophakia
- Being tested
- Visual Acuity, Defocus Curve, Halo and Glare testing, Patient Questionnaires
- Keywords
- Pseudophakia, Alcon PanOptix, Johnson & Johnson Tecnis Synergy
- Medical subject headings
- Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AcuityDiagnostic test
Measurement of distance, intermediate and near visual acuity.
Defocus CurveDiagnostic test
Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Halo and Glare testingDiagnostic test
Also called VS Halo & Glare (visu-med.com)
Measurement to quantify degree of visual loss caused by either halo and/or glare.
Patient QuestionnairesOther
Also called IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve; Diagnostic Test: Halo and Glare testing; Other: Patient Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post operatively
Secondary outcomes (9)
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
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.
Measured: 3 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start12 Sep 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PseudophakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berkeley Eye Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Micheletti, MD, Principal investigator, Berkeley Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041139
- Sponsor's protocol ID
- 69881171
- Status last verified
- May 2025
- First submitted
- 13 Jul 2022
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
- ClinicalTrials.gov ID
- NCT06041139
- Acronym / sponsor ID
- 69881171
- Conditions
- Pseudophakia
- Keywords
- Pseudophakia, Alcon PanOptix, Johnson & Johnson Tecnis Synergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcon PanOptix | – | Diagnostic Test: Visual Acuity, Diagnostic Test: Defocus Curve, Diagnostic Test: Halo and Glare testing, Other: Patient QuestionnairesPatients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. |
| Johnson & Johnson Synergy | – | Diagnostic Test: Visual Acuity, Diagnostic Test: Defocus Curve, Diagnostic Test: Halo and Glare testing, Other: Patient QuestionnairesPatients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with healthy eyes and uncomplicated bilateral implantation of Panoptix IOLs or Synergy IOLs.
Key inclusion criteria (9 listed)
- Are willing and able to understand and sign an informed consent
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual AcuityMeasurement of distance, intermediate and near visual acuity. | Diagnostic test | Alcon PanOptix, Johnson & Johnson Synergy |
| Defocus CurveMeasurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. | Diagnostic test | Alcon PanOptix, Johnson & Johnson Synergy |
| Halo and Glare testingAlso: VS Halo & Glare (visu-med.com)Measurement to quantify degree of visual loss caused by either halo and/or glare. | Diagnostic test | Alcon PanOptix, Johnson & Johnson Synergy |
| Patient QuestionnairesAlso: IOLSAT, QUVID and Self-Reported Visual Disturbance QuestionnairePatients 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. | Other | Alcon PanOptix, Johnson & Johnson Synergy |
Primary outcome
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm
Time frame: 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.
9 secondary outcomes
Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.
Time frame: 3 months post operatively
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.
Time frame: 3 months post operatively
Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.
Time frame: 3 months post operatively
Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.
Time frame: 3 months post operatively
Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.
Time frame: 3 months post operatively
Binocular Target Corrected Defocus Curve
Time frame: 3 months post operatively
Patient Reported Satisfaction by IOLSAT Questionnaire.
Time frame: 3 months post operatively
Patient Reported Dysphotopsias Questionnaire (QUVID).
Time frame: 3 months post operatively
Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).
Time frame: 3 months post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pseudophakia
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
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Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
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Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
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Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Micheletti, MD principal investigator
Berkeley Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudophakia, run by Berkeley Eye Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm (time frame: 3 months post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.