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Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V

NCT05574959 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2026-01-20

No results posted yet for this study

Summary

Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.

Conditions

  • Cataracts

Interventions

DEVICE

investigational IOL Model DEN00V

Eligible subjects will be randomized in a 1:1 ratio to receive the investigational IOL Model DEN00V in both eyes for the duration of the study.

DEVICE

control IOL Model ZCB00/DCB00

Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model ZCB00/DCB00 in both eyes for the duration of the study.

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Surgical Vision, Inc. Clinical Trial · Johnson & Johnson Surgical Vision, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-24
Primary Completion
2023-10-24
Completion
2023-10-24
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 NCT05574959 on ClinicalTrials.gov