CataractBRAVONCT03949335
Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
A study testing IOL Model ZFR00V and IOL Model ZCB00 in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Corneal Astigmatism
- What is being tested?
- IOL Model ZFR00V and IOL Model ZCB00
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 15 sitesUnited States
- Study dates
- 31 Jul 2019to 18 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, 21401
Empire Eye & Laser Center
Bakersfield, California, 93309
Cincinnati Eye Institute
Blue Ash, Ohio, 45242
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Key-Whitman Eye Center
Dallas, Texas, 75243
Berkeley Eye Institute
Houston, Texas, 77027
Texas Eye and Laser Center
Hurst, Texas, 76054
Clarus Eye Centre
Lacey, Washington, 98503
Carolina EyeCare Physicians
Mt. Pleasant, South Carolina, 29464
Lehmann Eye Center
Nacogdoches, Texas, 75965
Focal Point Vision
San Antonio, Texas, 78209
Jones Eye Clinic
Sioux City, Iowa, 51104
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
Katzen Eye Care & Laser Center
West Palm Beach, Florida, 33401
About this study
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
- Conditions
- Cataract, Corneal Astigmatism
- Being tested
- IOL Model ZFR00V, IOL Model ZCB00
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL Model ZFR00VDevice
Bilateral implantation with Investigational IOL Model ZFR00V
IOL Model ZCB00Device
Bilateral Implantation with control IOL Model ZCB00
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Bilateral implantation with investigational IOL Model ZFR00V Receives: Device: IOL Model ZFR00V |
| Control | Active comparator | Bilateral implantation with control IOL Model ZCB00 Receives: Device: IOL Model ZCB00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
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
Measured: 6 months (postoperative)
Secondary outcomes (5)
Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm
mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population
Measured: 6 months (postoperative)
Monocular Distance-Corrected Near Visual Acuity at 33 cm
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
Measured: 6 months postoperative
Monocular Photopic Best-Corrected Distance Visual Acuity
mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.
Measured: 6 months postoperative
Monocular Distance-Corrected Defocus Curve
Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population
Measured: 6 months postoperative
Spectacle Wear
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.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start31 Jul 2019
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision Clinical Trials, Study director, Johnson & Johnson Surgical Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949335
- Sponsor's protocol ID
- SUR-CAT-652-2001
- Acronym
- BRAVO
- Status last verified
- Aug 2021
- First submitted
- 1 May 2019
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Publications
Chang DH, Hu JG, Lehmann RP, Thompson VM, Tsai LH, Thomas EK. Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial. J Cataract Refract Surg. 2023 Aug 1;49(8):840-847. doi: 10.1097/j.jcrs.0000000000001205.
PubMed 37097283
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
- ClinicalTrials.gov ID
- NCT03949335
- Acronym / sponsor ID
- BRAVO / SUR-CAT-652-2001
- Conditions
- Cataract, Corneal Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: IOL Model ZFR00VBilateral implantation with investigational IOL Model ZFR00V |
| Control | Active comparator | Device: IOL Model ZCB00Bilateral implantation with control IOL Model ZCB00 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOL Model ZFR00VBilateral implantation with Investigational IOL Model ZFR00V | Device | Investigational |
| IOL Model ZCB00Bilateral Implantation with control IOL Model ZCB00 | Device | Control |
Primary outcome
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
Time frame: 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
5 secondary outcomes
Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm
Time frame: 6 months (postoperative)
Monocular Distance-Corrected Near Visual Acuity at 33 cm
Time frame: 6 months postoperative
Monocular Photopic Best-Corrected Distance Visual Acuity
Time frame: 6 months postoperative
Monocular Distance-Corrected Defocus Curve
Time frame: 6 months postoperative
Spectacle Wear
Time frame: 6 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37097283Chang DH, Hu JG, Lehmann RP, Thompson VM, Tsai LH, Thomas EK. Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial. J Cataract Refract Surg. 2023 Aug 1;49(8):840-847. doi: 10.1097/j.jcrs.0000000000001205.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Surgical Vision Clinical Trials study director
Johnson & Johnson Surgical Vision
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL Model ZFR00V and IOL Model ZCB00 in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm (time frame: 6 months (postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.