Refractive AssessmentNCT04675489
Visual Outcomes After Vivity Toric IOL Implantation
A study testing Procedure: Vivity Toric IOL in people with Refractive Assessment, run by EVP Eye Care at 1 site in United States.
Trial summary
The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Assessment
- What is being tested?
- Procedure: Vivity Toric IOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 13 Dec 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6
- Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit
- Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator
Who cannot join
- Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity
- Ocular trauma or zonular weakness/instability
- Diagnosis of glaucoma or high-risk glaucoma suspect
- Previous refractive surgery
- Unreliable preoperative biometry measurements
- Severe dry eye or ocular surface disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens
The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.
Read the detailed description
To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.
- Conditions
- Refractive Assessment
- Being tested
- Procedure: Vivity Toric IOL
- Keywords
- Vivity, Extended Vision Toric Intraocular Lens, Patient satisfaction and visual outcomes
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Vivity Toric IOLOther
The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's Vivity Toric Extended Vision intraocular lens (IOL) for cataract patients. This innovative lens is an extended depth of focus IOL that has been reported to result in fewer visual disturbances than diffractive IOLs.
| Study group | Role | What they receive |
|---|---|---|
| Vivity Toric IOL | Other | Patients with cataract that had phacoemulsification and Vivity Toric IOL implantation. Receives: Other: Procedure: Vivity Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular visual acuity at distance
Monocular uncorrected distance visual acuity
Measured: 4 months
Binocular visual acuity at distance
Binocular uncorrected distance visual acuity
Measured: 4 months
Monocular best corrected distance visual acuity
Monocular best corrected distance visual acuity
Measured: 4 months
Binocular best corrected distance visual acuity
Binocular best corrected distance visual acuity
Measured: 4 months
Monocular best distance-corrected intermediate visual acuity
Monocular best distance-corrected intermediate visual acuity
Measured: 4 months
Binocular best distance-corrected intermediate visual acuity
Binocular best distance-corrected intermediate visual acuity
Measured: 4 months
Monocular best distance-corrected near visual acuity
Monocular best distance-corrected near visual acuity
Measured: 4 months
Binocular best distance-corrected near visual acuity
Binocular best distance-corrected near visual acuity
Measured: 4 months
Secondary outcomes (1)
Residual refractive cylinder
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start15 Jan 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Why it stopped: Difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive AssessmentStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular Lens
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- EVP Eye Care
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research, Icon Eye Care
- Responsible party
- Sponsor
- Investigators
- James Fox, MD, Principal investigator, Icon Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675489
- Sponsor's protocol ID
- 20-01
- Status last verified
- Dec 2020
- First submitted
- 13 Nov 2020
- Last updated
- 18 Jan 2022
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens
- ClinicalTrials.gov ID
- NCT04675489
- Acronym / sponsor ID
- 20-01
- Conditions
- Refractive Assessment
- Keywords
- Vivity, Extended Vision Toric Intraocular Lens, Patient satisfaction and visual outcomes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- EVP Eye CareUniversity, hospital or other
- Collaborators
- Alcon Research, Icon Eye Care
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 19 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 purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.
Detailed description
To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects to receive bilateral implantation of Vivity Extended Vision Toric Intraocular Lens
| Arm | Type | Receives |
|---|---|---|
| Vivity Toric IOL | Other | Other: Procedure: Vivity Toric IOLPatients with cataract that had phacoemulsification and Vivity Toric IOL implantation. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6
- Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit
- Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator
Key exclusion criteria (6 listed)
- Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity
- Ocular trauma or zonular weakness/instability
- Diagnosis of glaucoma or high-risk glaucoma suspect
- Previous refractive surgery
- Unreliable preoperative biometry measurements
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 |
|---|---|---|
| Procedure: Vivity Toric IOLThe U.S. Food and Drug Administration (FDA) has granted approval of Alcon's Vivity Toric Extended Vision intraocular lens (IOL) for cataract patients. This innovative lens is an extended depth of focus IOL that has been reported to result in fewer visual disturbances than diffractive IOLs. | Other | Vivity Toric IOL |
Primary outcome
Monocular visual acuity at distance
Time frame: 4 months
Monocular uncorrected distance visual acuity
Binocular visual acuity at distance
Time frame: 4 months
Binocular uncorrected distance visual acuity
Monocular best corrected distance visual acuity
Time frame: 4 months
Monocular best corrected distance visual acuity
Binocular best corrected distance visual acuity
Time frame: 4 months
Binocular best corrected distance visual acuity
Monocular best distance-corrected intermediate visual acuity
Time frame: 4 months
Monocular best distance-corrected intermediate visual acuity
Binocular best distance-corrected intermediate visual acuity
Time frame: 4 months
Binocular best distance-corrected intermediate visual acuity
Monocular best distance-corrected near visual acuity
Time frame: 4 months
Monocular best distance-corrected near visual acuity
Binocular best distance-corrected near visual acuity
Time frame: 4 months
Binocular best distance-corrected near visual acuity
1 secondary outcome
Residual refractive cylinder
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- 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.
James Fox, MD principal investigator
Icon Eye Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Vivity Toric IOL in people with Refractive Assessment, run by EVP Eye Care 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Jan 2022. 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 was stopped early (reason given: Difficulty in recruiting). Results are not available in the source record.
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?
Monocular visual acuity at distance (time frame: 4 months). The study lists 8 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 18 Jan 2022.