NCT06041139

Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Berkeley Eye Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pseudophakia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Visual Acuity	Measurement of distance, intermediate and near visual acuity.
DIAGNOSTIC_TEST	Defocus Curve	Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
DIAGNOSTIC_TEST	Halo and Glare testing	Measurement to quantify degree of visual loss caused by either halo and/or glare.
OTHER	Patient Questionnaires	Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2023-09-18
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study