- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03500198
Clinical Investigation of the Next Generation Intraocular Lens
June 24, 2020 updated by: Johnson & Johnson Surgical Vision, Inc.
Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
247
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Torrance, California, United States, 90505
- Wolstan & Goldberg Eye Associates
-
-
Florida
-
Bradenton, Florida, United States, 34209
- The Eye Associates of Manatee, LLP
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Jacksonville, Florida, United States, 32204
- Levenson Eye Associates, Inc.
-
-
Iowa
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Sioux City, Iowa, United States, 51104
- Jones Eye Clinic
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-
Ohio
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Cincinnati, Ohio, United States, 45242
- Cincinnati Eye Institute
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Pennsylvania
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Kingston, Pennsylvania, United States, 18704
- Eye Care Specialists
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South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Vance Thompson Vision Clinic, Prof LLC
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Texas
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Dallas, Texas, United States, 11442
- Key-Whitman Eye Center
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Houston, Texas, United States, 77027
- Berkeley Eye Institute, P.A.
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Houston, Texas, United States, 77027
- Slade & Baker Vision
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Investigational Device: Next Generation TECNIS IOL
Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
|
Intraocular lens replaces the natural lens removed during cataract surgery.
|
ACTIVE_COMPARATOR: Control Device: TECNIS Monofocal IOL
Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
|
Intraocular lens replaces the natural lens removed during cataract surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
Time Frame: 6 months (postoperative)
|
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.
|
6 months (postoperative)
|
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Time Frame: 6 months (postoperative)
|
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.
|
6 months (postoperative)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
Time Frame: 6 months (postoperative)
|
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.
|
6 months (postoperative)
|
Overall Spectacle Wear
Time Frame: 6 months (postoperative)
|
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".
|
6 months (postoperative)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Devi Priya Janakiraman, OD, FAAO, Johnson & Johnson Surgical Vision, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 28, 2018
Primary Completion (ACTUAL)
June 5, 2019
Study Completion (ACTUAL)
June 5, 2019
Study Registration Dates
First Submitted
April 9, 2018
First Submitted That Met QC Criteria
April 9, 2018
First Posted (ACTUAL)
April 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 25, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUR-IOL-652-2001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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