Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Berkeley Eye Center

Status

Enrolling

Conditions

Pseudophakia

Treatments

Diagnostic Test: Visual Acuity

Other: Patient Questionnaires

Diagnostic Test: Defocus Curve

Diagnostic Test: Halo and Glare testing

Study type

Observational

Funder types

Other

Identifiers

69881171

Details and patient eligibility

About

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.

Full 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.

Enrollment

310 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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)