CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 230 enrolled
Drug / intervention
Visual Acuity +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06041139
NCT06041139N/ACompleted

Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Berkeley Eye Center·observational·Posted Sep 18, 2023·Updated May 23, 2025

In Brief

An observational study evaluating Visual Acuity, Defocus Curve, and 2 other interventions for Pseudophakia. Completed, enrolled 230 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPseudophakia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 18, 2023
Enrollment StartSep 12, 2022
Primary CompletionApr 16, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 2.8 years ago

Interventions

Visual Acuityother

Measurement of distance, intermediate and near visual acuity.

Defocus Curveother

Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.

Halo and Glare testingother

Measurement to quantify degree of visual loss caused by either halo and/or glare.

Patient Questionnairesother

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.