CataractNCT04495049
Vivity Insight: A Study of Patient Satisfaction and Visual Performance
An observational study of Cataract, run by Research Insight LLC at 3 sites in United States.
Trial summary
This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Vivity or Vivity Toric implant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Alcon Vivity or Vivity Toric IOL
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2020to 30 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing cataract surgery.
Who may be able to join
- Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- Patients implanted with Vivity or Vivity Toric lenses bilaterally within 6 months of the survey administration.
- Patients whose postoperative manifest refraction at the time of the survey is within ± 0.5 D sphere and ≤0.75 D of cylindrical refraction.
- Patients who have given consent to participate in the survey.
Who cannot join
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would, the judgement of the investigator, influence the outcome measures of the study.
- Patients with previous refractive surgery within the past 6 months prior to cataract surgery.
- Patients with > grade 1 posterior capsule opacity at their last visit.
- Patients who do not meet the refractive endpoints described in the Inclusion Criteria.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Quantum Vision Center
Edwardsville, Illinois, 62025
Harvard Eye Associates
Laguna Hills, California, 92653
Quentin Allen
Palm City, Florida, 34990
About this study
This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Vivity or Vivity Toric implant.
Read the detailed description
Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent "zones" of uncorrected vision (distance and intermediate or intermediate and near) but have a track record of frequent patient dissatisfaction because of unwanted visual side effects, "spider webs" or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be encountered in clinical practice.
This study is designed to measure postoperative patient-reported outcomes with this new lens implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction, spectacle independence, and acceptable glare and halo profiles using a validated questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this study will be designed to mirror those previous studies using the same instrument.
All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of plano sphere.
- Conditions
- Cataract
- Being tested
- Alcon Vivity or Vivity Toric IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon Vivity or Vivity Toric IOLDevice
Patients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"
Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"
Measured: 8/1/2020 - 7/1/2021
Secondary outcomes (2)
Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"
Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"
Measured: 8/1/2020 - 7/1/2021
Percentage of postoperative patients who report that they do not require reading glasses for various activities
Percentage of postoperative patients who report that they do not require reading glasses for various activities (driving, reading, including fine print, seeing computer monitor, watching TV, sports/hobbies when asked "For what types of activities do you need glasses to see (other than sunglasses)?"
Measured: 8/1/2020 - 7/1/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Aug 2020
- Primary completion30 Apr 2021
- Study completion30 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Insight LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495049
- Sponsor's protocol ID
- 1911 Vivity ALC57290333
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vivity Insight: A Study of Patient Satisfaction and Visual Performance
- ClinicalTrials.gov ID
- NCT04495049
- Acronym / sponsor ID
- 1911 Vivity ALC57290333
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Research Insight LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 31 Jul 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.
This will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the Vivity or Vivity Toric implant.
Detailed description
Existing diffractive extended depth of focus (EDOF) lenses provide two adjacent "zones" of uncorrected vision (distance and intermediate or intermediate and near) but have a track record of frequent patient dissatisfaction because of unwanted visual side effects, "spider webs" or haloes. The Vivity non-diffractive EDOF lens offers this same range ofvision with contrast sensitivity similar to a monofocal lens, which suggests fewer side effects will be encountered in clinical practice.
This study is designed to measure postoperative patient-reported outcomes with this new lens implant. Previous studies we have conducted on the bilateral ReSTOR 3.0, ReSTOR with ActiveFocus 2.5 (mixed with 3.0 and alone with mini-monovision) have shown high satisfaction, spectacle independence, and acceptable glare and halo profiles using a validated questionnaire instrument developed by MDbackline, Inc. The postoperative portions of this study will be designed to mirror those previous studies using the same instrument.
All subjects will receive the Vivity or Vivity Toric implant binocularly with a target of plano sphere.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cataract surgery.
Key inclusion criteria (4 listed)
- Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- Patients implanted with Vivity or Vivity Toric lenses bilaterally within 6 months of the survey administration.
- Patients whose postoperative manifest refraction at the time of the survey is within ± 0.5 D sphere and ≤0.75 D of cylindrical refraction.
- Patients who have given consent to participate in the survey.
Key exclusion criteria (5 listed)
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would, the judgement of the investigator, influence the outcome measures of the study.
- Patients with previous refractive surgery within the past 6 months prior to cataract surgery.
- Patients with > grade 1 posterior capsule opacity at their last visit.
- Patients who do not meet the refractive endpoints described in the Inclusion Criteria.
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 |
|---|---|---|
| Alcon Vivity or Vivity Toric IOLPatients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes. | Device | – |
Primary outcome
Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"
Time frame: 8/1/2020 - 7/1/2021
Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?"
2 secondary outcomes
Percentage of postoperative patients who report "rarely" when asked "How often do you need glasses to see the computer?"
Time frame: 8/1/2020 - 7/1/2021
Percentage of postoperative patients who report that they do not require reading glasses for various activities
Time frame: 8/1/2020 - 7/1/2021
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 3 Jun 2021.
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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.
3 sites 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 Research Insight LLC at 3 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 4 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Percentage of patients reporting "not at all" or "just a little" when asked, "With or without glasses, how much do you notice glare or haloes around lights in dim light situations?" (time frame: 8/1/2020 - 7/1/2021). 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 3 Jun 2021.