Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Completed

Conditions studied: Pseudophakia

In brief

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.

Key facts

Study ID

NCT06041139

Run by

Berkeley Eye Center

People needed

230

Starts

2022-09-12

Expected to finish

2024-04-16

Last updated by the study team

2025-05-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Berkeley Eye Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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