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
15
2
10.6
18.1
1.7
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
| Arm | Intervention/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
- 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
- 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
- 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
- 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.
- 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
- 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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Empire Eye & Laser Center | Bakersfield | California | United States | 93309 |
| 2 | Wolstan & Goldberg Eye Associates | Torrance | California | United States | 90505 |
| 3 | Katzen Eye Care & Laser Center | West Palm Beach | Florida | United States | 33401 |
| 4 | Jones Eye Clinic | Sioux City | Iowa | United States | 51104 |
| 5 | Chesapeake Eye Care & Laser Center | Annapolis | Maryland | United States | 21401 |
| 6 | Cincinnati Eye Institute | Blue Ash | Ohio | United States | 45242 |
| 7 | Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | United States | 16066 |
| 8 | Carolina EyeCare Physicians | Mount Pleasant | South Carolina | United States | 29464 |
| 9 | Vance Thompson Vision | Sioux Falls | South Dakota | United States | 57108 |
| 10 | Key-Whitman Eye Center | Dallas | Texas | United States | 75243 |
| 11 | Berkeley Eye Institute | Houston | Texas | United States | 77027 |
| 12 | Texas Eye and Laser Center | Hurst | Texas | United States | 76054 |
| 13 | Lehmann Eye Center | Nacogdoches | Texas | United States | 75965 |
| 14 | Focal Point Vision | San Antonio | Texas | United States | 78209 |
| 15 | Clarus Eye Centre | Lacey | Washington | United States | 98503 |
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 Detail | 272 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 Title | ZFR00V | ZCB00 |
|---|---|---|
| Arm/Group Description | Study Lens | Control Lens |
| Period Title: Overall Study | ||
| STARTED | 135 | 137 |
| COMPLETED | 132 | 131 |
| NOT COMPLETED | 3 | 6 |
Baseline Characteristics
| Arm/Group Title | ZFR00V | ZCB00 | Total |
|---|---|---|---|
| Arm/Group Description | Study Lens | Control Lens | Total of all reporting groups |
| Overall Participants | 135 | 137 | 272 |
| 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
| Title | Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm |
|---|---|
| Description | 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 |
| Time Frame | 6 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 Title | ZFR00V | ZCB00 |
|---|---|---|
| Arm/Group Description | Study Lens | Control Lens |
| Measure Participants | 131 | 130 |
| Measure Eyes | 131 | 130 |
| 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 Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm |
|---|---|
| Description | mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population |
| Time Frame | 6 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 Title | ZFR00V | ZCB00 |
|---|---|---|
| Arm/Group Description | Study Lens | Control Lens |
| Measure Participants | 131 | 130 |
| Measure Eyes | 131 | 130 |
| 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 Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Monocular Distance-Corrected Near Visual Acuity at 33 cm |
|---|---|
| Description | 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 |
| Time Frame | 6 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 Title | ZFR00V | ZCB00 |
|---|---|---|
| Arm/Group Description | Study Lens | Control Lens |
| Measure Participants | 131 | 130 |
| Measure Eyes | 131 | 130 |
| 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 Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Monocular Photopic Best-Corrected Distance Visual Acuity |
|---|---|
| Description | mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population. |
| Time Frame | 6 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 Title | ZFR00V | ZCB00 |
|---|---|---|
| Arm/Group Description | Study Lens | Control Lens |
| Measure Participants | 131 | 130 |
| Measure Eyes | 131 | 130 |
| 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 Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.031 | |
| Confidence Interval |
(2-Sided) 95% -0.053 to -0.010 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Monocular Distance-Corrected Defocus Curve |
|---|---|
| Description | Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population |
| Time Frame | 6 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 Title | ZFR00V | ZCB00 |
|---|---|---|
| Arm/Group Description | Study Lens | Control Lens |
| Measure Participants | 131 | 130 |
| Measure Eyes | 131 | 130 |
| Mean (Full Range) [diopter] |
-3.3
|
-0.9
|
| Title | Spectacle Wear |
|---|---|
| Description | 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. |
| Time Frame | 6 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 Title | ZFR00V | ZCB00 |
|---|---|---|
| Arm/Group Description | Study Lens | Control Lens |
| Measure Participants | 131 | 131 |
| 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 Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | 6 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 Title | ZFR00V First Eye | ZCB00 First Eye | ZFR00V Second Eye | ZCB00 Second Eye | ||||
| Arm/Group Description | Study Lens | Control Lens | Study Lens | Control Lens | ||||
All Cause Mortality |
||||||||
| ZFR00V First Eye | ZCB00 First Eye | ZFR00V Second Eye | ZCB00 Second Eye | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/135 (0%) | 0/137 (0%) | 0/135 (0%) | 0/137 (0%) | ||||
Serious Adverse Events |
||||||||
| ZFR00V First Eye | ZCB00 First Eye | ZFR00V Second Eye | ZCB00 Second Eye | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/135 (4.4%) | 2/137 (1.5%) | 8/135 (5.9%) | 3/137 (2.2%) | ||||
| Cardiac disorders | ||||||||
| Hospitalization | 0/135 (0%) | 0 | 1/137 (0.7%) | 1 | 0/135 (0%) | 0 | 1/137 (0.7%) | 1 |
| Eye disorders | ||||||||
| Cystoid Macular Edema | 1/135 (0.7%) | 1 | 1/137 (0.7%) | 1 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Retinal Detachment/tear | 0/135 (0%) | 0 | 0/137 (0%) | 0 | 0/135 (0%) | 0 | 1/137 (0.7%) | 1 |
| Macular Hole | 0/135 (0%) | 0 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Herpes Simplex Virus Keratitis | 0/135 (0%) | 0 | 0/137 (0%) | 0 | 0/135 (0%) | 0 | 1/137 (0.7%) | 1 |
| Corneal Ulcers | 0/135 (0%) | 0 | 0/137 (0%) | 0 | 0/135 (0%) | 0 | 1/137 (0.7%) | 1 |
| General disorders | ||||||||
| Hospitalization | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Abdominal Hernia requiring surgical repair | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Infections and infestations | ||||||||
| Hospitalization | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Fractured right fibula and dislocated ankle requiring surgery | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Product Issues | ||||||||
| Undesirable Optical Phenomena | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 | 0/135 (0%) | 0 | 0/137 (0%) | 0 |
| Toxic Anterior Segment Syndrome | 0/135 (0%) | 0 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Hypopyon | 0/135 (0%) | 0 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| Retained lens material resulting in secondary surgical intervention | 0/135 (0%) | 0 | 0/137 (0%) | 0 | 1/135 (0.7%) | 1 | 0/137 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| ZFR00V First Eye | ZCB00 First Eye | ZFR00V Second Eye | ZCB00 Second Eye | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/135 (7.4%) | 0/137 (0%) | 0/135 (0%) | 0/137 (0%) | ||||
| Product Issues | ||||||||
| Undesirable Optical Phenomena | 10/135 (7.4%) | 10 | 0/137 (0%) | 0 | 0/135 (0%) | 0 | 0/137 (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/Title | Eugenia Thomas, OD |
|---|---|
| Organization | Johnson & Johnson Surgical Vision |
| Phone | +1 657 2903260 |
| ethoma39@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