CataractNCT05210569
Visual Outcomes of Vivity in Patients With High Axial Length
An observational study of Cataract, run by Dr. James J. Wiens Medical Corporation at 1 site in Canada.
Trial summary
The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Vivity
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2022to 6 Sep 2023
- Phase
- Observational
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.
Who may be able to join
- Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
- Gender: Males and Females.
- Age: 50 years or older.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
- Motivated for greater degree of spectacle independence vs monofocal IOL.
- Axial length ≥24.5mm in both eyes.
- Planned cataract removal by femtosecond laser.
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular comorbidity that might hamper postoperative visual acuity.
- Previous refractive surgery.
- Irregular corneal astigmatism.
- Evidence of keratoconus as per Pentacam.
- Expected post-op VA worse than 20/25 (Snellen).
Show all 14Show fewer
- Refractive lens exchange.
- Difficulties comprehending written or spoken English language.
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
- Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.
- Axial length <24.5mm.
- Evidence of macular pathology as per optical coherence tomography examination.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length
The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.
Read the detailed description
This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.
- Conditions
- Cataract
- Being tested
- Vivity
- Keywords
- EDOF IOL Vivity
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivityDevice
Vivity intraocular lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| Bilateral implantation of the Vivity IOL | Vivity intraocular lens (IOL) Receives: Device: Vivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Uncorrected Distance Visual Acuity (logMAR)
Binocular uncorrected distance visual acuity (logMAR)
Measured: 3 months postoperatively
Binocular Uncorrected Intermediate Visual Acuity (logMAR)
Binocular uncorrected intermediate visual acuity (logMAR)
Measured: 3 months postoperatively
Binocular Uncorrected Near Visual Acuity (logMAR)
Binocular uncorrected near visual acuity (logMAR)
Measured: 3 months postoperatively
Secondary outcomes (11)
Prediction Error
Percentage of eyes with absolute prediction error of 0.5D or less
Measured: 3 months postoperatively
Binocular Corrected Distance Visual Acuity (logMAR)
Binocular corrected distance visual acuity (logMAR)
Measured: 3 months postoperatively
Binocular Distance Corrected Intermediate Visual Acuity (logMAR)
Binocular distance corrected intermediate visual acuity (logMAR)
Measured: 3 months postoperatively
Binocular Distance Corrected Near Visual Acuity (logMAR)
Binocular distance corrected near visual acuity (logMAR)
Measured: 3 months postoperatively
Monocular Corrected Distance Visual Acuity (logMAR)
Monocular corrected distance visual acuity (logMAR)
Measured: 3 months postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (logMAR)
Monocular distance corrected intermediate visual acuity (logMAR)
Measured: 3 months postoperatively
Monocular Distance Corrected Near Visual Acuity (logMAR)
Monocular distance corrected near visual acuity (logMAR)
Measured: 3 months postoperatively
Manifest Refraction Spherical Equivalent
Manifest refraction spherical equivalent
Measured: 3 months postoperatively
Questionnaire
Questionnaire for visual disturbance scores (QUVID)
Measured: 3 months postoperatively
Percentage of Participants With Spectacle Independence
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.
Measured: 3 months
Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)
Binocular distance-corrected low contrast distance visual acuity (logMAR)
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start13 Jan 2022
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
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.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. James J. Wiens Medical Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- James J Wiens, MD, Principal investigator, Dr. James J. Wiens Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210569
- Sponsor's protocol ID
- JW-21-001
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2022
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length
- ClinicalTrials.gov ID
- NCT05210569
- Acronym / sponsor ID
- JW-21-001
- Conditions
- Cataract
- Keywords
- EDOF IOL Vivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. James J. Wiens Medical CorporationUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.
Detailed description
This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral implantation of the Vivity IOL | – | Device: VivityVivity intraocular lens (IOL) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.
Key inclusion criteria (8 listed)
- Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
- Gender: Males and Females.
- Age: 50 years or older.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
Key exclusion criteria (14 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular comorbidity that might hamper postoperative visual acuity.
- Previous refractive surgery.
- Irregular corneal astigmatism.
- Evidence of keratoconus as per Pentacam.
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 |
|---|---|---|
| VivityVivity intraocular lens (IOL) | Device | Bilateral implantation of the Vivity IOL |
Primary outcome
Binocular Uncorrected Distance Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Binocular uncorrected distance visual acuity (logMAR)
Binocular Uncorrected Intermediate Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Binocular uncorrected intermediate visual acuity (logMAR)
Binocular Uncorrected Near Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Binocular uncorrected near visual acuity (logMAR)
11 secondary outcomes
Prediction Error
Time frame: 3 months postoperatively
Binocular Corrected Distance Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Binocular Distance Corrected Intermediate Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Binocular Distance Corrected Near Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Monocular Corrected Distance Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Monocular Distance Corrected Near Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Manifest Refraction Spherical Equivalent
Time frame: 3 months postoperatively
Questionnaire
Time frame: 3 months postoperatively
Percentage of Participants With Spectacle Independence
Time frame: 3 months
Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)
Time frame: 3 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 J Wiens, MD principal investigator
Dr. James J. Wiens Medical Corporation
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 Dr. James J. Wiens Medical Corporation at 1 site in Canada.
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 8 inclusion and 14 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 11 Mar 2025. 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 Canada. 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 6 Feb 2025). 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?
Binocular Uncorrected Distance Visual Acuity (logMAR) (time frame: 3 months postoperatively). 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 11 Mar 2025.