AphakiaNCT06541795
Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses
A study testing AcrySof IQ Vivity Extended Vision IOL in people with Aphakia and Presbyopia, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Presbyopia, Residual Refractive Cylinder
- What is being tested?
- AcrySof IQ Vivity Extended Vision IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Dec 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years old or older at Visit 1.
- Able to understand and sign an approved informed consent form.
- Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
- Documented medical history and required pre-operative baseline information available for retrospective data collection.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
- Pregnant or nursing at the time of enrollment.
- Childbirth after IOL implantation.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Evaluation of Long-term Safety and Performance of AcrySof IQ Vivity Extended Vision and AcrySof IQ Vivity Toric Extended Vision Intraocular Lenses
The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.
Read the detailed description
This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.
This study will be conducted in the US and in Spain.
- Conditions
- Aphakia, Presbyopia, Residual Refractive Cylinder
- Being tested
- AcrySof IQ Vivity Extended Vision IOL
- Keywords
- Cataracts
- Medical subject headings
- Aphakia, Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof IQ Vivity Extended Vision IOLDevice
Also called AcrySof IQ Vivity Extended Vision IOL: Model DFT015, AcrySof IQ Vivity Extended Vision UV Absorbing IOL: Model DAT015, AcrySof IQ Vivity Toric Extended Vision IOL: Models DFT215, DFT315, DFT415, DFT515 and DFT615 according to country of conduct, AcrySof IQ Vivity Toric Extended Vision UV Absorbing IOL: Models DAT315, DAT415, DAT515 and DAT615 according to country of conduct
UV-absorbing, with or without blue light filtering, foldable IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients from whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing an extended depth of focus. The toric models in addition reduce residual refractive astigmatism in patients with pre-existing corneal astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL | Experimental | AcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery Receives: Device: AcrySof IQ Vivity Extended Vision IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1
Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place using letter charts at a distance of 4 meters. BCVA will be recorded in logarithm Minimum Angle of Resolution (logMAR) LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. No hypothesis testing is prespecified for this endpoint.
Measured: Visit 1, Year 3-5 postoperative
Incidence of adverse events
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study device. Adverse events reported or observed since the time of initial exposure to the study model IOL will be recorded.
Measured: Up to Year 3-5 postoperative
Incidence of device deficiencies
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies reported or observed since the time of initial exposure to the study model IOL will be recorded.
Measured: Up to Year 3-5 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management Operations, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541795
- Sponsor's protocol ID
- ILI875-I001
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Safety and Performance of AcrySof IQ Vivity Extended Vision and AcrySof IQ Vivity Toric Extended Vision Intraocular Lenses
- ClinicalTrials.gov ID
- NCT06541795
- Acronym / sponsor ID
- ILI875-I001
- Conditions
- Aphakia, Presbyopia, Residual Refractive Cylinder
- Keywords
- Cataracts
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Aug 2024 (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 post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.
Detailed description
This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.
This study will be conducted in the US and in Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL | Experimental | Device: AcrySof IQ Vivity Extended Vision IOLAcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 22 years old or older at Visit 1.
- Able to understand and sign an approved informed consent form.
- Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
- Documented medical history and required pre-operative baseline information available for retrospective data collection.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
- Pregnant or nursing at the time of enrollment.
- Childbirth after IOL implantation.
- Other protocol-specified exclusion criteria may apply.
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 |
|---|---|---|
| AcrySof IQ Vivity Extended Vision IOLAlso: AcrySof IQ Vivity Extended Vision IOL: Model DFT015, AcrySof IQ Vivity Extended Vision UV Absorbing IOL: Model DAT015, AcrySof IQ Vivity Toric Extended Vision IOL: Models DFT215, DFT315, DFT415, DFT515 and DFT615 according to country of conduct, AcrySof IQ Vivity Toric Extended Vision UV Absorbing IOL: Models DAT315, DAT415, DAT515 and DAT615 according to country of conductUV-absorbing, with or without blue light filtering, foldable IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients from whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing an extended depth of focus. The toric models in addition reduce residual refractive astigmatism in patients with pre-existing corneal astigmatism. | Device | AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL |
Primary outcome
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1
Time frame: Visit 1, Year 3-5 postoperative
Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place using letter charts at a distance of 4 meters. BCVA will be recorded in logarithm Minimum Angle of Resolution (logMAR) LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. No hypothesis testing is prespecified for this endpoint.
Incidence of adverse events
Time frame: Up to Year 3-5 postoperative
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study device. Adverse events reported or observed since the time of initial exposure to the study model IOL will be recorded.
Incidence of device deficiencies
Time frame: Up to Year 3-5 postoperative
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies reported or observed since the time of initial exposure to the study model IOL will be recorded.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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.
Clinical Trial Management Operations, 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?
A study testing AcrySof IQ Vivity Extended Vision IOL in people with Aphakia and Presbyopia, run by Alcon Research 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 4 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: withdrawn, as of the sponsor's last update on 15 Sep 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 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 withdrawn before enrolling participants, so there are no results.
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?
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1 (time frame: Visit 1, Year 3-5 postoperative). 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 15 Sep 2025.