CataractREVIVENCT04561570
Long Term Outcomes of Vivity Intra Ocular Lens(IOL) Versus Control
An observational study of Cataract, run by John Berdahl, MD at 1 site in United States.
Trial summary
Evaluate the long-term (>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Vivity ACRYSOF IQ IOL Group
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 27 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 45-60 subjects will be enrolled (30-45 subjects that received the Vivity IOL and 15-20 subjects that received the control lens in the FDA clinical trial) across up to five investigational sites.
Who may be able to join
- Must have participated in the FDA study at one of the included sites
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: Long Term Outcomes of Vivity IOL Versus Control
Evaluate the long-term (>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.
- Conditions
- Cataract
- Being tested
- Vivity ACRYSOF IQ IOL Group, ACRYSOF IQ IOL Control Group
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivity ACRYSOF IQ IOL GroupDevice
Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens
ACRYSOF IQ IOL Control GroupDevice
Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens
| Study group | Role | What they receive |
|---|---|---|
| Study Group: Vivity ACRYSOF IQ IOL | Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens Receives: Device: Vivity ACRYSOF IQ IOL Group | |
| Control Group: ACRYSOF IQ IOL | Control Group: Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens Receives: Device: ACRYSOF IQ IOL Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Distance Visual Acuity (BCDVAA)
Best correct distance visual acuity
Measured: After 1 year post-op
Best Corrected Intermediate Visual Acuity (BCIVA)
Best correct intermediate visual acuity
Measured: After 1 year post-op
Defocus Curve
Measured: After 1 year post-op
Secondary outcomes (5)
Uncorrected Distance Visual Acuity (UCDVA)
Uncorrected Distance Visual Acuity
Measured: After 1 year post-op
UCNVA
Uncorrected Near Visual Acuity
Measured: After 1 year post-op
Dyphotopsia rate
Demonstrated by responses on questionnaire
Measured: After 1 year post-op
Post-operative IOLSAT
Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome
Measured: After 1 year post-op
(Post-operative QUVID)
Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome
Measured: After 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start17 Sep 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Berdahl, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research, The Eye Associates, Eye Care Specialists, NewsomeEye
- Responsible party
- Sponsor-investigator, John Berdahl, MD, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561570
- Sponsor's protocol ID
- The REVIVE Study
- Acronym
- REVIVE
- Status last verified
- Jul 2023
- First submitted
- 11 Sep 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of Vivity IOL Versus Control
- ClinicalTrials.gov ID
- NCT04561570
- Acronym / sponsor ID
- REVIVE / The REVIVE Study
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- John Berdahl, MDUniversity, hospital or other
- Collaborators
- Alcon Research, The Eye Associates, Eye Care Specialists, NewsomeEye
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the long-term (>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group: Vivity ACRYSOF IQ IOL | – | Device: Vivity ACRYSOF IQ IOL GroupSubjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens |
| Control Group: ACRYSOF IQ IOL | – | Device: ACRYSOF IQ IOL Control GroupControl Group: Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 45-60 subjects will be enrolled (30-45 subjects that received the Vivity IOL and 15-20 subjects that received the control lens in the FDA clinical trial) across up to five investigational sites.
Key inclusion criteria (1 listed)
- Must have participated in the FDA study at one of the included sites
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Vivity ACRYSOF IQ IOL GroupSubjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens | Device | Study Group: Vivity ACRYSOF IQ IOL |
| ACRYSOF IQ IOL Control GroupSubject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens | Device | Control Group: ACRYSOF IQ IOL |
Primary outcome
Best Corrected Distance Visual Acuity (BCDVAA)
Time frame: After 1 year post-op
Best correct distance visual acuity
Best Corrected Intermediate Visual Acuity (BCIVA)
Time frame: After 1 year post-op
Best correct intermediate visual acuity
Defocus Curve
Time frame: After 1 year post-op
5 secondary outcomes
Uncorrected Distance Visual Acuity (UCDVA)
Time frame: After 1 year post-op
UCNVA
Time frame: After 1 year post-op
Dyphotopsia rate
Time frame: After 1 year post-op
Post-operative IOLSAT
Time frame: After 1 year post-op
(Post-operative QUVID)
Time frame: After 1 year post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by John Berdahl, MD at 1 site 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 1 inclusion and 1 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Best Corrected Distance Visual Acuity (BCDVAA) (time frame: After 1 year post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.