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Clinical Investigation of the Next Generation Intraocular Lens

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
Control Monofocal Intraocular Lens: TECNIS Monofocal 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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Minimum 22 years of age
  • Bilateral cataracts for which posterior chamber IOL implantation has been planned
  • Corneal astigmatism:
  • Normal corneal topography
  • Availability, willingness 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:

  • Irregular corneal astigmatism
  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
  • Poorly-controlled diabetes
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
  • Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction

Sites / Locations

  • Wolstan & Goldberg Eye Associates
  • The Eye Associates of Manatee, LLP
  • Levenson Eye Associates, Inc.
  • Jones Eye Clinic
  • Cincinnati Eye Institute
  • Eye Care Specialists
  • Vance Thompson Vision Clinic, Prof LLC
  • Key-Whitman Eye Center
  • Berkeley Eye Institute, P.A.
  • Slade & Baker Vision

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational Device: Next Generation TECNIS IOL

Control Device: TECNIS Monofocal IOL

Arm Description

Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL

Control Monofocal Intraocular Lens: TECNIS Monofocal IOL

Outcomes

Primary Outcome Measures

Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.

Secondary Outcome Measures

Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only.
Overall Spectacle Wear
Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time".

Full Information

First Posted
April 9, 2018
Last Updated
June 24, 2020
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03500198
Brief Title
Clinical Investigation of the Next Generation Intraocular Lens
Official Title
Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
June 5, 2019 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
Detailed Description
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.

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
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Device: Next Generation TECNIS IOL
Arm Type
Experimental
Arm Description
Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
Arm Title
Control Device: TECNIS Monofocal IOL
Arm Type
Active Comparator
Arm Description
Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
Intervention Type
Device
Intervention Name(s)
Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
Intervention Description
Intraocular lens replaces the natural lens removed during cataract surgery.
Intervention Type
Device
Intervention Name(s)
Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
Intervention Description
Intraocular lens replaces the natural lens removed during cataract surgery.
Primary Outcome Measure Information:
Title
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
Description
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Time Frame
6 months (postoperative)
Title
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Description
Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.
Time Frame
6 months (postoperative)
Secondary Outcome Measure Information:
Title
Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Description
Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only.
Time Frame
6 months (postoperative)
Title
Overall Spectacle Wear
Description
Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time".
Time Frame
6 months (postoperative)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Minimum 22 years of age Bilateral cataracts for which posterior chamber IOL implantation has been planned Corneal astigmatism: Normal corneal topography Availability, willingness 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: Irregular corneal astigmatism Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs Poorly-controlled diabetes Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes 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
Devi Priya Janakiraman, OD, FAAO
Organizational Affiliation
Johnson & Johnson Surgical Vision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
The Eye Associates of Manatee, LLP
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Levenson Eye Associates, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Jones Eye Clinic
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Vance Thompson Vision Clinic, Prof LLC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
11442
Country
United States
Facility Name
Berkeley Eye Institute, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Slade & Baker Vision
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Investigation of the Next Generation Intraocular Lens

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