Visual AcuityNCT05414565
Post-Market Study of Alcon Intraocular Lenses
An observational study of Visual Acuity, run by Alcon Research at 1 site in Australia.
Trial summary
The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Vivity IOL and Aspheric monofocal IOL
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Sep 2022to 15 Apr 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from ophthalmology practices who implant the Alcon Vivity and Alcon aspheric monofocal IOLs.
Who may be able to join
- In good general health at the screening visit;
- Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon);
- Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together;
- BCDVA of 20/40 or better in each eye;
Who cannot join
- Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion;
- History of ocular surgery other than cataract surgery and Nd:YAG laser surgery;
- History of amblyopia.
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Optometry and Vision Science, Queensland University of Technology
Kelvin Grove, Queensland, 4059
About this study
Official title: Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs
The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.
Read the detailed description
This observational study will enroll subjects who have been implanted with an Alcon aspheric monofocal or monofocal toric IOL no less than 4 months prior to study procedures. This study will be conducted in Australia.
- Conditions
- Visual Acuity
- Being tested
- Vivity IOL, Aspheric monofocal IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivity IOLDevice
Also called Acrysof IQ Vivity or Vivity toric IOL
Commercially available extended vision IOL
Aspheric monofocal IOLDevice
Also called Acrysof IQ monofocal or monofocal toric IOL, Clareon monofocal or monofocal toric IOL
Commercially available aspheric IOL
| Study group | Role | What they receive |
|---|---|---|
| Vivity IOL | Subjects previously implanted with Vivity or Vivity toric IOL Receives: Device: Vivity IOL | |
| Aspheric Monofocal IOL | Subjects previously implanted with an aspheric monofocal or monofocal toric IOL Receives: Device: Aspheric monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular photopic best-corrected distance visual acuity (BCDVA)
Visual acuity will be measured using a standard visual acuity chart at a distance of 4 meters under photopic (well-lit) conditions and reported in logarithm Minimum Angle of Resolution (logMAR) units. Visual acuity will be measured binocularly (both eyes together).
Measured: At least 4 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start15 Sep 2022
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Queensland University of Technology
- Responsible party
- Sponsor
- Investigators
- Director of Clinical Projects, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414565
- Sponsor's protocol ID
- A04429
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2022
- Last updated
- 9 Jul 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs
- ClinicalTrials.gov ID
- NCT05414565
- Acronym / sponsor ID
- A04429
- Conditions
- Visual Acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Queensland University of Technology
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 10 Jun 2022 (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 the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.
Detailed description
This observational study will enroll subjects who have been implanted with an Alcon aspheric monofocal or monofocal toric IOL no less than 4 months prior to study procedures. This study will be conducted in Australia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivity IOL | – | Device: Vivity IOLSubjects previously implanted with Vivity or Vivity toric IOL |
| Aspheric Monofocal IOL | – | Device: Aspheric monofocal IOLSubjects previously implanted with an aspheric monofocal or monofocal toric IOL |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from ophthalmology practices who implant the Alcon Vivity and Alcon aspheric monofocal IOLs.
Key inclusion criteria (4 listed)
- In good general health at the screening visit;
- Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon);
- Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together;
- BCDVA of 20/40 or better in each eye;
Key exclusion criteria (3 listed)
- Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion;
- History of ocular surgery other than cataract surgery and Nd:YAG laser surgery;
- History of amblyopia.
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 IOLAlso: Acrysof IQ Vivity or Vivity toric IOLCommercially available extended vision IOL | Device | Vivity IOL |
| Aspheric monofocal IOLAlso: Acrysof IQ monofocal or monofocal toric IOL, Clareon monofocal or monofocal toric IOLCommercially available aspheric IOL | Device | Aspheric Monofocal IOL |
Primary outcome
Binocular photopic best-corrected distance visual acuity (BCDVA)
Time frame: At least 4 months post-operative
Visual acuity will be measured using a standard visual acuity chart at a distance of 4 meters under photopic (well-lit) conditions and reported in logarithm Minimum Angle of Resolution (logMAR) units. Visual acuity will be measured binocularly (both eyes together).
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 9 Jul 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.
Director of Clinical Projects, Surgical study director
Alcon Research, LLC
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 Visual Acuity, run by Alcon Research at 1 site in Australia.
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 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 9 Jul 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 Australia. 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?
Binocular photopic best-corrected distance visual acuity (BCDVA) (time frame: At least 4 months post-operative). 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 9 Jul 2024.