Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

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

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: Test IOL Model DEN00V; Device: Control IOL Model DCB00

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Center
  • New York
    • Garden City, New York, United States, 11530
      • OCLI Vision
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision
  • Texas
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
    • Houston, Texas, United States, 77027
      • Berkeley Eye Institute
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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
• be available for study follow-up visits 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test IOL; DEN00V	Device: 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
Active Comparator: Control IOL; DCB00	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular photopic DCNVA at 40 cm (first eyes)	Mean DCNVA (logMAR) in the test lens group is statistically significantly better (smaller) than in the control lens group	6 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Actual): April 23, 2025
• Study Completion (Actual): April 23, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PCOL109PHNG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes