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Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

NCT06041139 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2025-05-23

Study results available
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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.

Conditions

  • Pseudophakia

Interventions

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.

Sponsors & Collaborators

  • Berkeley Eye Center

    lead OTHER

Principal Investigators

  • Morgan Micheletti, MD · Berkeley Eye Center

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2024-04-16
Completion
2024-04-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06041139 on ClinicalTrials.gov