Clinical Investigation of the Next Generation Intraocular Lens

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03500198
Collaborator
(none)
247
Enrollment
10
Locations
2
Arms
11.2
Actual Duration (Months)
24.7
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
  • Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
247 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
Actual Study Start Date :
Jun 28, 2018
Actual Primary Completion Date :
Jun 5, 2019
Actual Study Completion Date :
Jun 5, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Investigational Device: Next Generation TECNIS IOL

Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL

Device: 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

Device: Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
Intraocular lens replaces the natural lens removed during cataract surgery.

Outcome Measures

Primary Outcome Measures

  1. Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) [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.

  2. Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve [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.

Secondary Outcome Measures

  1. Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm [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.

  2. Overall Spectacle Wear [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Wolstan & Goldberg Eye AssociatesTorranceCaliforniaUnited States90505
2The Eye Associates of Manatee, LLPBradentonFloridaUnited States34209
3Levenson Eye Associates, Inc.JacksonvilleFloridaUnited States32204
4Jones Eye ClinicSioux CityIowaUnited States51104
5Cincinnati Eye InstituteCincinnatiOhioUnited States45242
6Eye Care SpecialistsKingstonPennsylvaniaUnited States18704
7Vance Thompson Vision Clinic, Prof LLCSioux FallsSouth DakotaUnited States57108
8Key-Whitman Eye CenterDallasTexasUnited States11442
9Berkeley Eye Institute, P.A.HoustonTexasUnited States77027
10Slade & Baker VisionHoustonTexasUnited States77027

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Devi Priya Janakiraman, OD, FAAO, Johnson & Johnson Surgical Vision, Inc.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03500198
Other Study ID Numbers:
  • SUR-IOL-652-2001
First Posted:
Apr 18, 2018
Last Update Posted:
Jun 25, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailTotal of 247 participants signed the informed consent form and out of them 27 participants were never randomized and treated, 2 were randomized but not treated. Hence 218 participants were implanted lens in the first eye, (110 in ZHR00 and 108 in ZCB00 control group).
Arm/Group TitleInvestigational Device: ZHR00Control Device: ZCB00
Arm/Group DescriptionInvestigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
Period Title: Overall Study
STARTED110108
First Eye110108
Second Eye109108
COMPLETED110107
NOT COMPLETED01

Baseline Characteristics

Arm/Group TitleInvestigational Device: ZHR00Control Device: ZCB00Total
Arm/Group DescriptionInvestigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.Total of all reporting groups
Overall Participants110108218
Age, Customized (Number) [Number]
less than < 60 Years
15
13.6%
13
12%
28
12.8%
60-69 Years
49
44.5%
49
45.4%
98
45%
70-79 Years
43
39.1%
40
37%
83
38.1%
Greater than or equal to >= 80 Years
3
2.7%
6
5.6%
9
4.1%
Sex: Female, Male (Count of Participants)
Female
71
64.5%
75
69.4%
146
67%
Male
39
35.5%
33
30.6%
72
33%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
7
6.4%
3
2.8%
10
4.6%
Not Hispanic or Latino
102
92.7%
105
97.2%
207
95%
Unknown or Not Reported
1
0.9%
0
0%
1
0.5%
Race/Ethnicity, Customized (Number) [Number]
Asian (including Indian)
4
3.6%
3
2.8%
7
3.2%
Black
6
5.5%
14
13%
20
9.2%
Native Hawaiian/Pacific Islander
0
0%
1
0.9%
1
0.5%
Caucasian
99
90%
90
83.3%
189
86.7%
Other Race
1
0.9%
0
0%
1
0.5%
American Indian/Alaska Native
0
0%
0
0%
0
0%
Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleMonocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
DescriptionVisual 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 Frame6 months (postoperative)

Outcome Measure Data

Analysis Population Description
The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure.
Arm/Group TitleInvestigational Device: ZHR00Control Device: ZCB00
Arm/Group DescriptionInvestigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
Measure Participants110107
Measure Eyes110107
Mean (Standard Deviation) [logMAR]
0.053
(0.149)
0.370
(0.173)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Device: ZHR00, Control Device: ZCB00
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value< 0.0001
Comments
Methodt-test, 1 sided
Comments
2. Primary Outcome
TitleMonocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
DescriptionDepth 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 Frame6 months (postoperative)

Outcome Measure Data

Analysis Population Description
The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure.
Arm/Group TitleInvestigational Device: ZHR00Control Device: ZCB00
Arm/Group DescriptionInvestigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
Measure Participants109106
Measure Eyes109106
Mean (Full Range) [diopter]
2.3
0.8
3. Secondary Outcome
TitleMonocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
DescriptionVisual 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 Frame6 months (postoperative)

Outcome Measure Data

Analysis Population Description
The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure.
Arm/Group TitleInvestigational Device: ZHR00Control Device: ZCB00
Arm/Group DescriptionInvestigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
Measure Participants110106
Measure Eyes110106
Mean (Standard Deviation) [LogMAR]
0.151
(0.148)
0.466
(0.203)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Device: ZHR00, Control Device: ZCB00
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<0.0001
Comments
Methodt-test, 1 sided
Comments
4. Secondary Outcome
TitleOverall Spectacle Wear
DescriptionOverall 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 Frame6 months (postoperative)

Outcome Measure Data

Analysis Population Description
The modified intent-to-treat (mITT) population included all eyes randomized and implanted with either a test or control study intraocular lens (IOL) in the study. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleInvestigational Device: ZHR00Control Device: ZCB00
Arm/Group DescriptionInvestigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery.
Measure Participants109108
Number [Percentage of participants]
63.3
57.5%
7.6
7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Device: ZHR00, Control Device: ZCB00
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<0.0001
Comments
Method1-sided logistic regression
Comments

Adverse Events

Time FrameUp to 11.5 months
Adverse Event Reporting Description The SF population included all eyes and participants implanted in at least one eye with either a test or control IOL with data available at the time of analysis (that is, no data imputation). Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes.
Arm/Group TitleInvestigational Device: ZHR00 (First Eye)Control Device: ZCB00 (First Eye)Investigational Device: ZHR00 (Second Eye)Control Device: ZCB00 (Second Eye)
Arm/Group DescriptionInvestigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.Investigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system.
All Cause Mortality
Investigational Device: ZHR00 (First Eye)Control Device: ZCB00 (First Eye)Investigational Device: ZHR00 (Second Eye)Control Device: ZCB00 (Second Eye)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/110 (0%) 0/108 (0%) 0/109 (0%) 0/108 (0%)
Serious Adverse Events
Investigational Device: ZHR00 (First Eye)Control Device: ZCB00 (First Eye)Investigational Device: ZHR00 (Second Eye)Control Device: ZCB00 (Second Eye)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/110 (4.5%) 5/108 (4.6%) 6/109 (5.5%) 4/108 (3.7%)
Cardiac disorders
Hospitalization for myocardial infarction1/110 (0.9%) 11/108 (0.9%) 11/109 (0.9%) 11/108 (0.9%) 1
Eye disorders
Retinal Detachment0/110 (0%) 02/108 (1.9%) 20/109 (0%) 01/108 (0.9%) 1
Cystoid macular edema0/110 (0%) 01/108 (0.9%) 10/109 (0%) 01/108 (0.9%) 1
Hypopyon0/110 (0%) 00/108 (0%) 01/109 (0.9%) 10/108 (0%) 0
Gastrointestinal disorders
Hospitalization for vomiting1/110 (0.9%) 10/108 (0%) 01/109 (0.9%) 10/108 (0%) 0
Product Issues
Lens dislocation0/110 (0%) 00/108 (0%) 01/109 (0.9%) 10/108 (0%) 0
Respiratory, thoracic and mediastinal disorders
Hospitalization for Pneumonia2/110 (1.8%) 20/108 (0%) 02/109 (1.8%) 20/108 (0%) 0
Surgical and medical procedures
Cortical Remnant in anterior chamber1/110 (0.9%) 10/108 (0%) 00/109 (0%) 00/108 (0%) 0
Vascular disorders
Atherosclerosis with intermittent claudication0/110 (0%) 01/108 (0.9%) 10/109 (0%) 01/108 (0.9%) 1
Other (Not Including Serious) Adverse Events
Investigational Device: ZHR00 (First Eye)Control Device: ZCB00 (First Eye)Investigational Device: ZHR00 (Second Eye)Control Device: ZCB00 (Second Eye)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total9/110 (8.2%) 1/108 (0.9%) 9/109 (8.3%) 1/108 (0.9%)
Product Issues
Adverse Device Effects due to visual symptoms9/110 (8.2%) 91/108 (0.9%) 19/109 (8.3%) 91/108 (0.9%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime

Results Point of Contact

Name/TitleDevi Priya Janakiraman, OD, FAAO
OrganizationJohnson & Johnson Surgical Vision
Phone+1 714 247- 8628
Emaildjanaki1@its.jnj.com
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03500198
Other Study ID Numbers:
  • SUR-IOL-652-2001
First Posted:
Apr 18, 2018
Last Update Posted:
Jun 25, 2020
Last Verified:
Jun 1, 2020