Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

NCT ID: NCT06377514

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2025-04-23

Brief Summary

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Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Test IOL

DEN00V

Group Type EXPERIMENTAL

Test IOL Model DEN00V

Intervention Type DEVICE

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

Control IOL

DCB00

Group Type ACTIVE_COMPARATOR

Control IOL Model DCB00

Intervention Type DEVICE

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

Interventions

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Test IOL Model DEN00V

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

Intervention Type DEVICE

Control IOL Model DCB00

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

To be considered for enrollment in this study, patient must:

* be at least 22 years old
* have cataracts in both eyes
* sign the written informed consent
* be willing and able to comply with examination procedures
* understand, read and write English to complete informed consent and questionnaires

Exclusion Criteria

Patient will not be eligible to take part in the study if:

* currently participating in any other clinical study or have participated in a clinical study during the last 30 days
* have a certain disease/illness, such as poorly controlled diabetes
* have certain ocular conditions, such as uncontrolled pressure in the eye
* taking medication that may affect vision
* pregnant, plan to become pregnant during the study, or are breastfeeding
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision, Inc.

Locations

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Empire Eye & Laser Center

Bakersfield, California, United States

Site Status

Levenson Eye Associates

Jacksonville, Florida, United States

Site Status

Jones Eye Center

Sioux City, Iowa, United States

Site Status

OCLI Vision

Garden City, New York, United States

Site Status

Cleveland Eye Clinic

Brecksville, Ohio, United States

Site Status

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Berkeley Eye Center

Houston, Texas, United States

Site Status

Whitsett Vision Group

Houston, Texas, United States

Site Status

Parkhurst NuVision

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PCOL109PHNG

Identifier Type: -

Identifier Source: org_study_id