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A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects

NCT06922084 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-04-10

No results posted yet for this study

Summary

Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.

Conditions

  • Cataract

Interventions

DEVICE

Clareon PanOptix

Bilateral Clareon PanOptix IOL implantation

DRUG

Clareon PanOptix PRO

Bilateral Clareon PanOptix PRO IOL implantation

DRUG

Mix-and-Match PanOptix/Vivity

Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

Sponsors & Collaborators

  • Sengi

    collaborator INDUSTRY

  • Berkeley Eye Center

    lead OTHER

Principal Investigators

  • Morgan Micheletti, MD · Berkeley Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2026-04-30
Completion
2026-04-30
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 NCT06922084 on ClinicalTrials.gov