Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

NCT06377514 | Completed Results FDA Device

• 1 other identifier: PCOL109PHNG
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Cataracts

Outcome Measures

Primary Outcomes (4)

• Monocular (First Eyes) Photopic DCIVA at 66 cm

  Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.

  6 months

• Monocular (First Eyes) Depth of Focus

  Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye.

  6 months

• Monocular (First Eyes) Photopic BCDVA at 4m

  Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.

  6 months

• Monocular (First Eyes) Photopic DCVA at 100 cm

  Monocular photopic Distance Corrected Visual Acuity (DCVA) in logMAR at 100 cm for first eyes. This analysis was prespecified for the first operative eye.

  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 DEN00V 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

Test IOL

Control IOL Model DCB00 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

Control IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

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 Diseases; Eye Diseases

Results Point of Contact

• Title: Xu Cheng
• Organization: Johnson & Johnson Surgical Vision

XCHENG6@its.jnj.com

1904 4431245

Study Officials

• Johnson & Johnson Surgical Vision, Inc. Clinical Trial

  Johnson & Johnson Surgical Vision, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: July 17, 2026
• Results First Posted: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (9)