GlaucomaVIVANCT04670575
Vivity Outcomes in Patients With Early Stage Glaucoma
An observational study of Glaucoma and Cataract, run by Vance Thompson Vision at 1 site in United States.
Trial summary
The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Glaucoma, Cataract, Presbyopia
- What is being tested?
- Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 Nov 2022
- 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 45 years and older
- All sexes
- Adult, Older adult
Study population: Patients with early stage glaucoma with cataracts in both eyes who are planned to have bilateral cataract surgery with implantation of Vivity or Vivity Toric intraocular lens.
Who may be able to join
- Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS)
- Subjects with documented diagnosis of pre-perimetric glaucoma
- Calculated lens power within Vivity/Vivity toric range
- Willing and able to comprehend informed consent and complete 4-6 month post-op visit
- Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion
Who cannot join
- Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA
- Previous ocular surgery including refractive surgery
- Subjects who are pregnant or plan to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).
- Conditions
- Glaucoma, Cataract, Presbyopia
- Being tested
- Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL
- Keywords
- Extended Range of Vision, Intraocular Lens Technology, Glaucoma
- Medical subject headings
- Glaucoma, Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract Surgery with Implantation of Vivity Extended Range of Vision IOLProcedure or surgery
Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL
| Study group | Role | What they receive |
|---|---|---|
| Vivity | Patients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery. Receives: Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Distance Visual Acuity
Measured: 4-6 months
Uncorrected Intermediate Visual Acuity
Measured: 4-6 months
Uncorrected Near Visual Acuity
Measured: 4-6 months
Secondary outcomes (3)
Contrast Sensitivity
As measured by Pelli Robson Chart
Measured: 4-6 months
Patient Satisfaction and Spectacle Independence Survey Results
Measured: 4-6 months
Mean Refractive Spherical Equivalent
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2021
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian M Shafer, MD, Principal investigator, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670575
- Sponsor's protocol ID
- VIVA
- Acronym
- VIVA
- Status last verified
- May 2024
- First submitted
- 13 Dec 2020
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vivity Outcomes in Patients With Early Stage Glaucoma
- ClinicalTrials.gov ID
- NCT04670575
- Acronym / sponsor ID
- VIVA / VIVA
- Conditions
- Glaucoma, Cataract, Presbyopia
- Keywords
- Extended Range of Vision, Intraocular Lens Technology, Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 17 Dec 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.
The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivity | – | Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOLPatients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with early stage glaucoma with cataracts in both eyes who are planned to have bilateral cataract surgery with implantation of Vivity or Vivity Toric intraocular lens.
Key inclusion criteria (5 listed)
- Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS)
- Subjects with documented diagnosis of pre-perimetric glaucoma
- Calculated lens power within Vivity/Vivity toric range
- Willing and able to comprehend informed consent and complete 4-6 month post-op visit
- Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion
Key exclusion criteria (3 listed)
- Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA
- Previous ocular surgery including refractive surgery
- Subjects who are pregnant or plan to become pregnant during the course of the study.
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 |
|---|---|---|
| Cataract Surgery with Implantation of Vivity Extended Range of Vision IOLPatients with early stage glaucoma implanted with Vivity or Vivity Toric IOL | Procedure or surgery | Vivity |
Primary outcome
Uncorrected Distance Visual Acuity
Time frame: 4-6 months
Uncorrected Intermediate Visual Acuity
Time frame: 4-6 months
Uncorrected Near Visual Acuity
Time frame: 4-6 months
3 secondary outcomes
Contrast Sensitivity
Time frame: 4-6 months
Patient Satisfaction and Spectacle Independence Survey Results
Time frame: 4-6 months
Mean Refractive Spherical Equivalent
Time frame: 4-6 months
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 20 May 2024.
- Individual participant dataSharing planned: No
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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.
Brian M Shafer, MD principal investigator
Vance Thompson Vision
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 Glaucoma and Cataract, run by Vance Thompson Vision 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 5 inclusion and 3 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 20 May 2024. 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?
Uncorrected Distance Visual Acuity (time frame: 4-6 months). 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 20 May 2024.