visual outcomes and patient satisfaction with bilateral panoptix verses bilateral synergy

Conditions: Pseudophakia

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.

* 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)

Keywords: pseudophakia alcon panoptix johnson & johnson tecnis synergy