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

Primary Purpose

Cataracts

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
investigational IOL Model DEN00V
control IOL Model ZCB00/DCB00
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Empire Eye & Laser Center
  • Southern California Eye Physicians and Associates
  • Wolstan & Goldberg Eye Associates
  • Jones Eye Center
  • OCLI Vision
  • Cincinnati Eye Institute
  • Carolina EyeCare Physicians, LLC
  • Whitsett Vision Group
  • Focal Point Vision
  • Parkhurst NuVision

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

investigational Lens Device

Control Lens Device

Arm Description

investigational IOL Model DEN00V

control IOL Model ZCB00/DCB00

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
October 7, 2022
Last Updated
October 9, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05574959
Brief Title
Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V
Official Title
Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
November 9, 2024 (Anticipated)
Study Completion Date
November 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
investigational Lens Device
Arm Type
Experimental
Arm Description
investigational IOL Model DEN00V
Arm Title
Control Lens Device
Arm Type
Active Comparator
Arm Description
control IOL Model ZCB00/DCB00
Intervention Type
Device
Intervention Name(s)
investigational IOL Model DEN00V
Intervention Description
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
Intervention Name(s)
control IOL Model ZCB00/DCB00
Intervention Description
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.
Primary Outcome Measure Information:
Title
MONOCULAR PHOTOPIC DCIVA AT 66 CM
Description
Mean (logMAR) monocular DCIVA under photopic conditions at 66 cm for first eyes in the investigational vs. control lens groups.
Time Frame
at 6-month follow-up
Title
MONOCULAR PHOTOPIC BCDVA AT 4 M
Description
Mean (logMAR) monocular BCDVA under photopic conditions at 4 meters for first eyes in the investigational vs. control lens groups.
Time Frame
at 6-month follow-up
Title
Secondary Surgical Interventions (SSIs)
Description
The rate of Secondary Surgical Interventions (SSIs) related to optical properties of the lens in eyes of subjects in the investigational lens group
Time Frame
at 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Known ocular disease or pathology that, in the opinion of the investigator: may affect visual acuity; may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.); may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.); Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes; Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial; Desire for monovision correction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision, Inc. Clinical Trial
Organizational Affiliation
Johnson & Johnson Surgical Vision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Empire Eye & Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Southern California Eye Physicians and Associates
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Jones Eye Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
OCLI Vision
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Carolina EyeCare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
http://yoda.yale.edu

Learn more about this trial

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

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