NCT06377514

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 3, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

April 17, 2024

Last Update Submit

December 4, 2025

Conditions

Cataracts

Outcome Measures

Primary Outcomes (4)

  • Monocular photopic DCIVA (first eyes) at 66 cm

    Mean DCIVA (logMAR) in test lens group is statistically significantly better (smaller) than in the control lens group

    6 months

  • Monocular Depth of Focus

    Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero) for first eyes at 6 months

    6 months

  • Monocular Photopic BCDVA at 4m

    Monocular photopic BCDVA at 4 meters for first eyes at 6 months

    6 months

  • Monocular Photopic DCVA at 100 cm

    Monocular photopic DCVA at 100 cm for first eyes at 6 months

    6 months

Secondary Outcomes (1)

  • Monocular photopic DCNVA at 40 cm (first eyes)

    6 months

Study Arms (2)

Test IOL

EXPERIMENTAL

DEN00V

Device: Test IOL Model DEN00V

Control IOL

ACTIVE COMPARATOR

DCB00

Device: Control IOL Model DCB00

Interventions

Test IOL Model DEN00VDEVICE

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

Test IOL
Control IOL Model DCB00DEVICE

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

Control IOL

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Jones Eye Center

Sioux City, Iowa, 51104, United States

Location

OCLI Vision

Garden City, New York, 11530, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Berkeley Eye Institute

Houston, Texas, 77027, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Johnson & Johnson Surgical Vision, Inc. Clinical Trial

    Johnson & Johnson Surgical Vision, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

June 3, 2024

Primary Completion

April 23, 2025

Study Completion

April 23, 2025

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

More information

Locations

US(9)