Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Completed

Conditions: Pseudophakia

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

Registration Number: NCT06041139

Lead Sponsor: Berkeley Eye Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 230

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alcon PanOptix	Defocus Curve	Patients 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	Patient Questionnaires	Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Johnson & Johnson Synergy	Halo and Glare testing	Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Alcon PanOptix	Visual Acuity	Patients 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	Defocus Curve	Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Alcon PanOptix	Halo and Glare testing	Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
Alcon PanOptix	Patient Questionnaires	Patients 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	Visual Acuity	Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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.
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.
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.