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

NCT ID: NCT05574959

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2023-10-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

investigational Lens Device

investigational IOL Model DEN00V

Group Type: EXPERIMENTAL

investigational IOL Model DEN00V

Intervention Type: 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.

Control Lens Device

control IOL Model ZCB00/DCB00

Group Type: ACTIVE_COMPARATOR

control IOL Model ZCB00/DCB00

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision, Inc.

Locations

Empire Eye & Laser Center

Bakersfield, California, United States

Southern California Eye Physicians and Associates

Long Beach, California, United States

Wolstan & Goldberg Eye Associates

Torrance, California, United States

Jones Eye Center

Sioux City, Iowa, United States

OCLI Vision

Garden City, New York, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Carolina EyeCare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Whitsett Vision Group

Houston, Texas, United States

Focal Point Vision

San Antonio, Texas, United States

Parkhurst NuVision

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PCOL107AHNG

Identifier Type: -

Identifier Source: org_study_id