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

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.

Study Overview

• Status: Terminated
• Conditions: Cataracts
• Intervention / Treatment: Device: investigational IOL Model DEN00V; Device: control IOL Model ZCB00/DCB00

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
    • Long Beach, California, United States, 90805
      • Southern California Eye Physicians and Associates
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Center
  • New York
    • Garden City, New York, United States, 11530
      • OCLI Vision
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Carolina Eyecare Physicians, LLC
  • Texas
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
    • San Antonio, Texas, United States, 78209
      • Focal Point Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Minimum 22 years of age;
2. Bilateral cataracts for which posterior chamber IOL implantation has been planned;
3. Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source;
4. Potential for postoperative BCDVA of 20/30 Snellen or better;

5. Corneal astigmatism:

   1. Normal corneal topography;
   2. ≤ 1.0 D of preoperative keratometric astigmatism;
6. Clear intraocular media other than cataract;
7. Availability, ability, willingness and sufficient cognitive awareness to comply with examination procedures;
8. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
9. Ability to understand and respond to a questionnaire in English.

Exclusion Criteria:

1. Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D;
2. Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils);
3. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
4. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
5. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;
6. Irregular corneal astigmatism;
7. Inability to achieve keratometric stability for contact lens wearers (as defined in preoperative procedures);
8. History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs;
9. Recent ocular trauma that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
10. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;
11. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
12. Use of systemic or ocular medications that may affect vision;
13. Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
14. Poorly controlled diabetes;
15. Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable;

16. Known ocular disease or pathology that, in the opinion of the investigator:

    1. may affect visual acuity;
    2. may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.);
    3. may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.);
17. Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes;
18. Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial;
19. Desire for monovision correction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: investigational Lens Device; investigational IOL Model DEN00V	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.
Active Comparator: Control Lens Device; control IOL Model ZCB00/DCB00	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MONOCULAR PHOTOPIC DCIVA AT 66 CM	Mean (logMAR) monocular DCIVA under photopic conditions at 66 cm for first eyes in the investigational vs. control lens groups.	at 6-month follow-up
MONOCULAR PHOTOPIC BCDVA AT 4 M	Mean (logMAR) monocular BCDVA under photopic conditions at 4 meters for first eyes in the investigational vs. control lens groups.	at 6-month follow-up
Secondary Surgical Interventions (SSIs)	The rate of Secondary Surgical Interventions (SSIs) related to optical properties of the lens in eyes of subjects in the investigational lens group	at 6-month follow-up

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): October 24, 2022
• Primary Completion (Actual): October 24, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PCOL107AHNG

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