AphakiaNCT05852470
Evaluation of Clareon Vivity/Vivity Toric
A study testing Clareon Vivity/Vivity Toric Extended Vision IOL and Clareon Monofocal/Clareon Toric IOL in people with Aphakia, run by Alcon Research at 7 sites in United States.
Trial summary
This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphakia
- What is being tested?
- Clareon Vivity/Vivity Toric Extended Vision IOL and Clareon Monofocal/Clareon Toric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 7 sitesUnited States
- Study dates
- 23 May 2023to 27 Oct 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and sign an approved Informed Consent form
- Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
- Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
- Clinically significant PCO (posterior capsule opacification) affecting vision.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
Bloomfield Hills, Michigan, 48302
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
Eye Care Specialists
Kingston, Pennsylvania, 18704
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, 29464
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Wolstan Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric
This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.
Read the detailed description
Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.
- Conditions
- Aphakia
- Being tested
- Clareon Vivity/Vivity Toric Extended Vision IOL, Clareon Monofocal/Clareon Toric IOL
- Keywords
- Cataract, Intraocular lens
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon Vivity/Vivity Toric Extended Vision IOLDevice
Also called Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6, Clareon Vivity™ Extended Vision Hydrophobic IOL, Clareon Vivity™ Toric Extended Vision Hydrophobic IOL
Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Clareon Monofocal/Clareon Toric IOLDevice
Also called SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0), Clareon™ Aspheric Hydrophobic Acrylic IOL, Clareon™ Toric Aspheric Hydrophobic Acrylic IOL
Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
| Study group | Role | What they receive |
|---|---|---|
| Clareon Vivity/Vivity Toric | Experimental | Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation Receives: Device: Clareon Vivity/Vivity Toric Extended Vision IOL |
| Clareon Monofocal/Clareon Toric | Active comparator | Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation Receives: Device: Clareon Monofocal/Clareon Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
Measured: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
Measured: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Secondary outcomes (2)
Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 40 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together.
Measured: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The percentage was calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. A higher percentage is a better outcome.
Measured: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start23 May 2023
- Primary completion27 Oct 2023
- Study completion27 Oct 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical CRD, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852470
- Sponsor's protocol ID
- ILE632-C002
- Status last verified
- Feb 2026
- First submitted
- 2 May 2023
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric
- ClinicalTrials.gov ID
- NCT05852470
- Acronym / sponsor ID
- ILE632-C002
- Conditions
- Aphakia
- Keywords
- Cataract, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.
Detailed description
Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon Vivity/Vivity Toric | Experimental | Device: Clareon Vivity/Vivity Toric Extended Vision IOLPrevious implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
| Clareon Monofocal/Clareon Toric | Active comparator | Device: Clareon Monofocal/Clareon Toric IOLPrevious implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Understand and sign an approved Informed Consent form
- Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
- Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
- Clinically significant PCO (posterior capsule opacification) affecting vision.
- Other protocol-defined 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 |
|---|---|---|
| Clareon Vivity/Vivity Toric Extended Vision IOLAlso: Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6, Clareon Vivity™ Extended Vision Hydrophobic IOL, Clareon Vivity™ Toric Extended Vision Hydrophobic IOLExtended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient. | Device | Clareon Vivity/Vivity Toric |
| Clareon Monofocal/Clareon Toric IOLAlso: SY60WF, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, Clareon with AutonoMe (CCA0T0, CNA0T0), Clareon™ Aspheric Hydrophobic Acrylic IOL, Clareon™ Toric Aspheric Hydrophobic Acrylic IOLSingle vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient. | Device | Clareon Monofocal/Clareon Toric |
Primary outcome
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint.
2 secondary outcomes
Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant
Time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Aphakia
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
Aphakia, Presbyopia
Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Aphakia
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 Lead, Surgical CRD study director
Alcon Research, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clareon Vivity/Vivity Toric Extended Vision IOL and Clareon Monofocal/Clareon Toric IOL in people with Aphakia, run by Alcon Research at 7 sites 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 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: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 5 Nov 2024). 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?
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant (time frame: Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation)). The study lists 2 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 24 Feb 2026.