Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

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.

* 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.

Eligibility Criteria:
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)