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Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tecnis Eyhance
Tecnis 1 piece IOL
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

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 best corrected visual acuity of 20/30 Snellen or better

  • Corneal astigmatism parameters:

    • Normal corneal topography and no irregular corneal astigmatism
    • Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
  • Clear intraocular media other than cataract in each eye
  • Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
  • 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:

  • Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction

Sites / Locations

  • Empire Eye & Laser Center
  • Southern California Eye Physicians and Associates
  • Center For Sight
  • Jones Eye Clinic
  • Chesapeake Eye Care & Laser Center
  • Tekwani Vision Center
  • Scott & Christie and Associates, PC
  • Eye Care Specialists
  • Key-Whitman Eye Center
  • Berkeley Eye Institute, P.A.
  • Whitsett Vision Group
  • Texas Eye and Laser Center
  • Focal Point Vision
  • Parkhurst NuVision
  • R & R Eye Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Lens

Control Lens

Arm Description

Tecnis Eyhance

Tecnis 1 piece IOL (Intraocular lens)

Outcomes

Primary Outcome Measures

MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups

Secondary Outcome Measures

MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups

Full Information

First Posted
August 26, 2021
Last Updated
August 25, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05025345
Brief Title
Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses
Official Title
Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 17, 2022 (Actual)

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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study Lens
Arm Type
Experimental
Arm Description
Tecnis Eyhance
Arm Title
Control Lens
Arm Type
Active Comparator
Arm Description
Tecnis 1 piece IOL (Intraocular lens)
Intervention Type
Device
Intervention Name(s)
Tecnis Eyhance
Intervention Description
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Intervention Type
Device
Intervention Name(s)
Tecnis 1 piece IOL
Intervention Description
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Primary Outcome Measure Information:
Title
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
Description
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
Description
the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups
Time Frame
6 months

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 best corrected visual acuity of 20/30 Snellen or better Corneal astigmatism parameters: Normal corneal topography and no irregular corneal astigmatism Postoperative astigmatism can be surgically managed to be less than 1 D in each eye Clear intraocular media other than cataract in each eye Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits 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: Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) Concurrent participation or participation within 60 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 Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
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
Center For Sight
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Jones Eye Clinic
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Chesapeake Eye Care & Laser Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16606
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Berkeley Eye Institute, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Texas Eye and Laser Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
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
Facility Name
R & R Eye Research, LLC
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 Devices Companies have an agreement with the Yale Open Data Access (YODA) Project 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

Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

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