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NCT06041139 · ClinicalTrials.gov registry record
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
A clinical trial, sponsored by Berkeley Eye Center.
- Completed
- Registry status
- 230
- Enrollment target
NCT06041139: Completed study, sponsored by Berkeley Eye Center.
NCT06041139 is a clinical trial that has completed, run by Berkeley Eye Center. The registered enrollment target is 230 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06041139 has completed, sponsored by Berkeley Eye Center.
- COMPLETED
- Registry status
- 230 participants
- Enrollment target
Study 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.
Primary Outcome
Binocular DCNVA Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Interventions
- OTHER Patient Questionnaires
- DIAGNOSTIC_TEST Visual Acuity
- DIAGNOSTIC_TEST Defocus Curve
- DIAGNOSTIC_TEST Halo and Glare testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2024-04-16 |
What the finished NCT06041139 record still lists
NCT06041139 is an observational study that tracks outcomes without assigning an intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which Patient Questionnaires is the first listed.
NCT06041139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06041139 about?
NCT06041139 is a clinical study titled "Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy". 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 ...
What is the current status of trial NCT06041139?
This trial is currently completed. The enrollment target is 230 participants. The study started on 2022-09-12. Estimated completion is 2024-04-16.
What interventions are being tested in trial NCT06041139?
The interventions under investigation include: Patient Questionnaires (OTHER), Visual Acuity (DIAGNOSTIC_TEST), Defocus Curve (DIAGNOSTIC_TEST), Halo and Glare testing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06041139?
This trial is sponsored by Berkeley Eye Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
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