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

NCT05574959 | Terminated FDA Device

• 1 other identifier: PCOL107AHNG
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

investigational Lens Device

EXPERIMENTAL

investigational IOL Model DEN00V

Device: investigational IOL Model DEN00V

Control Lens Device

ACTIVE COMPARATOR

control IOL Model ZCB00/DCB00

Device: control IOL Model ZCB00/DCB00

Interventions

investigational IOL Model DEN00V DEVICE

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.

investigational Lens Device

control IOL Model ZCB00/DCB00 DEVICE

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.

Control Lens Device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum 22 years of age;
• Bilateral cataracts for which posterior chamber IOL implantation has been planned;
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source;
• Potential for postoperative BCDVA of 20/30 Snellen or better;
• Corneal astigmatism:
• Normal corneal topography;
• ≤ 1.0 D of preoperative keratometric astigmatism;
• Clear intraocular media other than cataract;
• Availability, ability, willingness and sufficient cognitive awareness to comply with examination procedures;
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
• Ability to understand and respond to a questionnaire in English.

You may not qualify if:

• Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D;
• Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils);
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
• Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
• 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;
• Irregular corneal astigmatism;
• Inability to achieve keratometric stability for contact lens wearers (as defined in preoperative procedures);
• History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs;
• Recent ocular trauma that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
• 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;
• 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;
• Use of systemic or ocular medications that may affect vision;
• 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);
• Poorly controlled diabetes;
• 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;

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (10)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Southern California Eye Physicians and Associates

Long Beach, California, 90805, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Jones Eye Center

Sioux City, Iowa, 51104, United States

Location

OCLI Vision

Garden City, New York, 11530, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Carolina EyeCare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Focal Point Vision

San Antonio, Texas, 78209, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: October 24, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (10)