BRAVO: Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03949335
Collaborator
(none)
272
Enrollment
15
Locations
2
Arms
10.6
Actual Duration (Months)
18.1
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization.

After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule

Condition or DiseaseIntervention/TreatmentPhase
  • Device: IOL Model ZFR00V
  • Device: IOL Model ZCB00
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
272 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Only the surgeon and the operative staff will know which lens type is implanted and will be unmasked throughout the study. There may also be site coordinators and other site study staff, such as those performing slit-lamp exams, who will be unmasked. Unmasked study staff and study subjects will be instructed not to disclose the lens type the subject received or to talk about the lens to any subjects or masked evaluators. The subjects and the study technicians performing the postoperative vision tests are to be masked through study completion. To maintain subject/technician-masking through the 6-month study exams, a masking plan will be tailored for each site to detail how lens assignment information will be concealed from masked technicians.
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Actual Study Start Date :
Jul 31, 2019
Actual Primary Completion Date :
Jun 18, 2020
Actual Study Completion Date :
Jun 18, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Investigational

Bilateral implantation with investigational IOL Model ZFR00V

Device: IOL Model ZFR00V
Bilateral implantation with Investigational IOL Model ZFR00V

Active Comparator: Control

Bilateral implantation with control IOL Model ZCB00

Device: IOL Model ZCB00
Bilateral Implantation with control IOL Model ZCB00

Outcome Measures

Primary Outcome Measures

  1. Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm [6 months (postoperative)]

    mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months

Secondary Outcome Measures

  1. Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm [6 months (postoperative)]

    mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population

  2. Monocular Distance-Corrected Near Visual Acuity at 33 cm [6 months postoperative]

    mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months

  3. Monocular Photopic Best-Corrected Distance Visual Acuity [6 months postoperative]

    mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.

  4. Monocular Distance-Corrected Defocus Curve [6 months postoperative]

    Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population

  5. Spectacle Wear [6 months postoperative]

    Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • be at least 22 years old

  • have cataracts in both eyes

  • sign the written informed consent

  • be willing and able to comply with examination procedures

  • understand, read and write English to complete informed consent and questionnaires

  • be available for study follow-up visits

Exclusion Criteria:
  • currently participating in any other clinical study or have participated in a clinical study during the last 60 days

  • have a certain disease/illness such as poorly-controlled diabetes

  • have certain ocular conditions such as uncontrolled glaucoma

  • Is taking medication that may affect vision

  • Subject is pregnant, plan to become pregnant during the study, or is breastfeeding

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
2Wolstan & Goldberg Eye AssociatesTorranceCaliforniaUnited States90505
3Katzen Eye Care & Laser CenterWest Palm BeachFloridaUnited States33401
4Jones Eye ClinicSioux CityIowaUnited States51104
5Chesapeake Eye Care & Laser CenterAnnapolisMarylandUnited States21401
6Cincinnati Eye InstituteBlue AshOhioUnited States45242
7Scott & Christie and Associates, PCCranberry TownshipPennsylvaniaUnited States16066
8Carolina EyeCare PhysiciansMount PleasantSouth CarolinaUnited States29464
9Vance Thompson VisionSioux FallsSouth DakotaUnited States57108
10Key-Whitman Eye CenterDallasTexasUnited States75243
11Berkeley Eye InstituteHoustonTexasUnited States77027
12Texas Eye and Laser CenterHurstTexasUnited States76054
13Lehmann Eye CenterNacogdochesTexasUnited States75965
14Focal Point VisionSan AntonioTexasUnited States78209
15Clarus Eye CentreLaceyWashingtonUnited States98503

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03949335
Other Study ID Numbers:
  • SUR-CAT-652-2001
First Posted:
May 14, 2019
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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 Detail272 subjects were bilaterally implanted with either the study or control lens. 135 subjects were bilaterally implanted with the study lens and 137 subjects were bilaterally implanted with the control lens. All 272 subjects were bilaterally implanted with the same IOL model in both eyes.
Arm/Group TitleZFR00VZCB00
Arm/Group DescriptionStudy LensControl Lens
Period Title: Overall Study
STARTED135137
COMPLETED132131
NOT COMPLETED36

Baseline Characteristics

Arm/Group TitleZFR00VZCB00Total
Arm/Group DescriptionStudy LensControl LensTotal of all reporting groups
Overall Participants135137272
Age, Customized (Number) [Number]
<60
17
12.6%
17
12.4%
34
12.5%
60 to 69
50
37%
57
41.6%
107
39.3%
70 to 79
62
45.9%
56
40.9%
118
43.4%
> or = 80
6
4.4%
7
5.1%
13
4.8%
Sex: Female, Male (Count of Participants)
Female
94
69.6%
90
65.7%
184
67.6%
Male
41
30.4%
47
34.3%
88
32.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
8
5.9%
7
5.1%
15
5.5%
Not Hispanic or Latino
127
94.1%
130
94.9%
257
94.5%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Number) [Number]
Asian (including Indian)
3
2.2%
1
0.7%
4
1.5%
Black
15
11.1%
19
13.9%
34
12.5%
Native Hawaiian/Pacific Islander
1
0.7%
0
0%
1
0.4%
Caucasian
114
84.4%
116
84.7%
230
84.6%
Other Race
2
1.5%
1
0.7%
3
1.1%
Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleDistance-Corrected Near Visual Acuity (DCNVA) at 40 cm
Descriptionmean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months
Time Frame6 months (postoperative)

Outcome Measure Data

Analysis Population Description
The safety (SP) population for monocular Distance-Corrected Near Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
Arm/Group TitleZFR00VZCB00
Arm/Group DescriptionStudy LensControl Lens
Measure Participants131130
Measure Eyes131130
Mean (Standard Deviation) [LogMAR]
0.104
(0.138)
0.522
(0.193)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZFR00V, ZCB00
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<0.0001
Comments
Methodt-test, 1 sided
Comments
2. Secondary Outcome
TitleMonocular Distance-Corrected Intermediate Visual Acuity at 66 cm
Descriptionmean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population
Time Frame6 months (postoperative)

Outcome Measure Data

Analysis Population Description
The safety (SP) population for monocular Distance-Corrected Intermediate Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
Arm/Group TitleZFR00VZCB00
Arm/Group DescriptionStudy LensControl Lens
Measure Participants131130
Measure Eyes131130
Mean (Standard Deviation) [LogMAR]
0.060
(0.115)
0.335
(0.155)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZFR00V, ZCB00
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<0.0001
Comments
Methodt-test, 1 sided
Comments
3. Secondary Outcome
TitleMonocular Distance-Corrected Near Visual Acuity at 33 cm
Descriptionmean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months
Time Frame6 months postoperative

Outcome Measure Data

Analysis Population Description
The safety (SP) population for monocular Distance-Corrected Near Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
Arm/Group TitleZFR00VZCB00
Arm/Group DescriptionStudy LensControl Lens
Measure Participants131130
Measure Eyes131130
Mean (Standard Deviation) [LogMAR]
0.154
(0.151)
0.608
(0.187)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZFR00V, ZCB00
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<0.0001
Comments
Methodt-test, 1 sided
Comments
4. Secondary Outcome
TitleMonocular Photopic Best-Corrected Distance Visual Acuity
Descriptionmean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.
Time Frame6 months postoperative

Outcome Measure Data

Analysis Population Description
The safety (SP) population for monocular Best-Corrected Distance Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
Arm/Group TitleZFR00VZCB00
Arm/Group DescriptionStudy LensControl Lens
Measure Participants131130
Measure Eyes131130
Mean (Standard Deviation) [LogMAR]
-0.014
(0.087)
-0.045
(0.089)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZFR00V, ZCB00
Comments
Type of Statistical Test Non-Inferiority
Comments Noninferiority margin equals -0.1
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value-0.031
Confidence Interval (2-Sided) 95%
-0.053 to -0.010
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
TitleMonocular Distance-Corrected Defocus Curve
DescriptionMean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population
Time Frame6 months postoperative

Outcome Measure Data

Analysis Population Description
The safety (SP) population for monocular Distance-Corrected Defocus Curve include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
Arm/Group TitleZFR00VZCB00
Arm/Group DescriptionStudy LensControl Lens
Measure Participants131130
Measure Eyes131130
Mean (Full Range) [diopter]
-3.3
-0.9
6. Secondary Outcome
TitleSpectacle Wear
DescriptionSpectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.
Time Frame6 months postoperative

Outcome Measure Data

Analysis Population Description
The safety (SP) population for spectacle independence include all subjects implanted bilaterally with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
Arm/Group TitleZFR00VZCB00
Arm/Group DescriptionStudy LensControl Lens
Measure Participants131131
None of the time
115
85.2%
4
2.9%
A little/Some/Most/All of the time
16
11.9%
127
92.7%
Not reported
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZFR00V, ZCB00
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<0.0001
Comments
MethodFisher Exact
Comments

Adverse Events

Time Frame6 months
Adverse Event Reporting Description 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. The total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs. Only other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.
Arm/Group TitleZFR00V First EyeZCB00 First EyeZFR00V Second EyeZCB00 Second Eye
Arm/Group DescriptionStudy LensControl LensStudy LensControl Lens
All Cause Mortality
ZFR00V First EyeZCB00 First EyeZFR00V Second EyeZCB00 Second Eye
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/135 (0%) 0/137 (0%) 0/135 (0%) 0/137 (0%)
Serious Adverse Events
ZFR00V First EyeZCB00 First EyeZFR00V Second EyeZCB00 Second Eye
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/135 (4.4%) 2/137 (1.5%) 8/135 (5.9%) 3/137 (2.2%)
Cardiac disorders
Hospitalization0/135 (0%) 01/137 (0.7%) 10/135 (0%) 01/137 (0.7%) 1
Eye disorders
Cystoid Macular Edema1/135 (0.7%) 11/137 (0.7%) 11/135 (0.7%) 10/137 (0%) 0
Retinal Detachment/tear0/135 (0%) 00/137 (0%) 00/135 (0%) 01/137 (0.7%) 1
Macular Hole0/135 (0%) 00/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Herpes Simplex Virus Keratitis0/135 (0%) 00/137 (0%) 00/135 (0%) 01/137 (0.7%) 1
Corneal Ulcers0/135 (0%) 00/137 (0%) 00/135 (0%) 01/137 (0.7%) 1
General disorders
Hospitalization1/135 (0.7%) 10/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Abdominal Hernia requiring surgical repair1/135 (0.7%) 10/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Infections and infestations
Hospitalization1/135 (0.7%) 10/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Musculoskeletal and connective tissue disorders
Fractured right fibula and dislocated ankle requiring surgery1/135 (0.7%) 10/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Product Issues
Undesirable Optical Phenomena1/135 (0.7%) 10/137 (0%) 00/135 (0%) 00/137 (0%) 0
Toxic Anterior Segment Syndrome0/135 (0%) 00/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Hypopyon0/135 (0%) 00/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Surgical and medical procedures
Retained lens material resulting in secondary surgical intervention0/135 (0%) 00/137 (0%) 01/135 (0.7%) 10/137 (0%) 0
Other (Not Including Serious) Adverse Events
ZFR00V First EyeZCB00 First EyeZFR00V Second EyeZCB00 Second Eye
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total10/135 (7.4%) 0/137 (0%) 0/135 (0%) 0/137 (0%)
Product Issues
Undesirable Optical Phenomena10/135 (7.4%) 100/137 (0%) 00/135 (0%) 00/137 (0%) 0

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/TitleEugenia Thomas, OD
OrganizationJohnson & Johnson Surgical Vision
Phone+1 657 2903260
Emailethoma39@its.jnj.com
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03949335
Other Study ID Numbers:
  • SUR-CAT-652-2001
First Posted:
May 14, 2019
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021