Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06041139

Enrollment

230

Registered

2023-09-18

Start date

2022-09-12

Completion date

2024-04-16

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudophakia

Keywords

Pseudophakia, Alcon PanOptix, Johnson & Johnson Tecnis Synergy

Brief 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.

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.

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.

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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) * 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

* 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 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)

Design outcomes

Primary

Measure	Time frame	Description
Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm	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.

Secondary

Measure	Time frame	Description
Patient Reported Satisfaction by IOLSAT Questionnaire.	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.
Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.	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.
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.	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.
Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.	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.
Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.	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.
Patient Reported Dysphotopsias Questionnaire (QUVID).	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.
Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).	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.
Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.	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.
Binocular Target Corrected Defocus Curve	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.

Other

Measure	Time frame	Description
Spectacle Independence Utilizing the IOLSAT.	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.
Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus 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. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient 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.	153
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. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus 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. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient 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.	77
Total	230

Baseline characteristics

Characteristic	Alcon PanOptix	Johnson & Johnson Synergy	Total
Age, Continuous	65.6 years STANDARD_DEVIATION 8.3	65.9 years STANDARD_DEVIATION 10.2	65.7 years STANDARD_DEVIATION 9
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	87 Participants	51 Participants	138 Participants
Sex: Female, Male Male	66 Participants	26 Participants	92 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 153	0 / 77
other Total, other adverse events	0 / 153	0 / 77
serious Total, serious adverse events	0 / 153	0 / 77

Outcome results

Primary

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.