AstigmatismNCT06784063

Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)

A study testing Clareon Vivity Extended Vision IOL in people with Astigmatism, run by Alcon Research at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Astigmatism
What is being tested?: Clareon Vivity Extended Vision IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesUnited States
Study dates: 10 Apr 2025to 13 Jun 2025
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to understand and sign an Institution Review Board-approved informed consent form;
Willing and able to attend all scheduled study visits as required by the protocol;
Implanted with study IOLs in both eyes at least 4 months prior to study participation;
Best Corrected Distance Visual Acuity (BCDVA) of 0 logarithm minimum angle of resolution (logMAR) or better in each eye.

Who cannot join

Residual astigmatism greater than or equal to 1.00 diopter (D);
Clinically significant ocular conditions as specified in the protocol;
History of ocular surgeries other than limbal relaxing incisions
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Grosinger, Spigelman & Grey Eye Surgeons, P.C
Bloomfield Hills, Michigan, 48302
Key-Whitman Eye Center
Dallas, Texas, 75243
Berkeley Eye Center
Sugar Land, Texas, 77478

Other trials in United States

About this study

Official title: Evaluation of the Impact of Residual Astigmatism on the Visual Performance With Clareon Vivity

Read the detailed description

This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.

Conditions: Astigmatism
Being tested: Clareon Vivity Extended Vision IOL
Keywords: Cataract, IOL
Medical subject headings: Astigmatism, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clareon Vivity Extended Vision IOLDevice
Also called Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CNAET0, CNAET3, CNAET4, CNAET5, CNAET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6, CCAET0, CCAET3, CCAET4, CCAET5, CCAET6., Clareon Vivity™ Extended Vision Hydrophobic IOL, Clareon Vivity™ Extended Vision Hydrophobic Toric IOL, Clareon Vivity™ UV Absorbing 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.

Study groups in NCT06784063
Study group	Role	What they receive
Clareon Vivity/Vivity Toric	Experimental	Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation. Receives: Device: Clareon Vivity Extended Vision IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR
BCDVA was assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Trial lenses were used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Measured: Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 centimeters (cm) from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Measured: Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis.VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Measured: Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR
BCDVA was assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism against the rule (ATR), defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Measured: Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Measured: Day 0 before induced astigmatism; Day 0 after induced astigmatism
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - ATR
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Measured: Day 0 before induced astigmatism; Day 0 after induced astigmatism

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 202513 Jun 2025

First posted20 Jan 2025
Study start10 Apr 2025
Primary completion13 Jun 2025
Study completion13 Jun 2025

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 AstigmatismStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Subjects implanted with Clareon Vivity will be randomized to either with-the-rule (WTR) or against-the-rule (ATR) induced astigmatism first. Following the initial assessment, subjects will alternate between ATR and WTR for additional assessments based on a predefined randomization sheet.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06784063
Sponsor's protocol ID: ILE632-C003
Status last verified: Jul 2026
First submitted: 15 Jan 2025
Last updated: 13 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
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Recruiting
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Myopia, Astigmatism
Active, not recruiting
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Recruiting
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
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Not yet recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Impact of Residual Astigmatism on the Visual Performance With Clareon Vivity
ClinicalTrials.gov ID: NCT06784063
Acronym / sponsor ID: ILE632-C003
Conditions: Astigmatism
Keywords: Cataract, IOL
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 10 Apr 2025 (actual)
Primary completion: 13 Jun 2025 (actual)
Study completion: 13 Jun 2025 (actual)
First posted: 20 Jan 2025 (actual)
Results: Posted 13 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Subjects implanted with Clareon Vivity will be randomized to either with-the-rule (WTR) or against-the-rule (ATR) induced astigmatism first. Following the initial assessment, subjects will alternate between ATR and WTR for additional assessments based on a predefined randomization sheet.

Arm	Type	Receives
Clareon Vivity/Vivity Toric	Experimental	Device: Clareon Vivity Extended Vision IOLPrevious implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Able to understand and sign an Institution Review Board-approved informed consent form;
Willing and able to attend all scheduled study visits as required by the protocol;
Implanted with study IOLs in both eyes at least 4 months prior to study participation;
Best Corrected Distance Visual Acuity (BCDVA) of 0 logarithm minimum angle of resolution (logMAR) or better in each eye.

Key exclusion criteria (4 listed)

Residual astigmatism greater than or equal to 1.00 diopter (D);
Clinically significant ocular conditions as specified in the protocol;
History of ocular surgeries other than limbal relaxing incisions
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
Clareon Vivity Extended Vision IOLAlso: Models CNWET0, CNWET3, CNWET4, CNWET5, CNWET6, CNAET0, CNAET3, CNAET4, CNAET5, CNAET6, CCWET0, CCWET3, CCWET4, CCWET5, CCWET6, CCAET0, CCAET3, CCAET4, CCAET5, CCAET6., Clareon Vivity™ Extended Vision Hydrophobic IOL, Clareon Vivity™ Extended Vision Hydrophobic Toric IOL, Clareon Vivity™ UV Absorbing 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

Primary outcome

Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR
Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
BCDVA was assessed with best refractive correction in place at a distance of 4 meters (m) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Trial lenses were used to induce 1.0 diopter (D) of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR
Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 centimeters (cm) from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism with-the-rule (WTR), defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR
Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism WTR, defined as -0.50/+1.00 D at approximately 180 degrees on the optical axis.VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR
Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
BCDVA was assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism against the rule (ATR), defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism.- ATR
Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCIVA was assessed with distance correction in place (plus or minus power) at a distance of 66 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.
Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - ATR
Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism
DCNVA was assessed with distance correction in place (plus or minus power) at a distance of 40 cm from the spectacle plane using ETDRS letter charts. Trial lenses were used to induce 1.0 D of astigmatism ATR, defined as -0.50/+1.00 D at approximately 90 degrees on the optical axis. VA was measured in the first implanted eye in logarithm minimum angle of resolution (logMAR), with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism is reported, with a positive value representing a decline in VA. No hypothesis testing was prespecified for this co-primary endpoint.

Results and safety

Results posted to the registry on 13 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Started With WTR	20	20
Started With ATR	14	12

Primary outcome: Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR

Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism. Mean (Standard Deviation). Unit: logMAR

Measure	Clareon Vivity/Vivity Toric n = 31
Value	0.175 (0.1121)

Population analysed: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.

Primary outcome: Mean Difference in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 Centimeters) Before and After Inducing 1.0 D Astigmatism - WTR

Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism. Mean (Standard Deviation). Unit: logMAR

Measure	Clareon Vivity/Vivity Toric n = 31
Value	0.074 (0.1141)

Population analysed: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.

Primary outcome: Mean Difference in Monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) Before and After Inducing 1.0 D Astigmatism - WTR

Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism. Mean (Standard Deviation). Unit: logMAR

Measure	Clareon Vivity/Vivity Toric n = 31
Value	0.052 (0.1425)

Population analysed: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.

Primary outcome: Mean Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - ATR

Time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism. Mean (Standard Deviation). Unit: logMAR

Measure	Clareon Vivity/Vivity Toric n = 31
Value	0.184 (0.1321)

Population analysed: Full Analysis Set: All enrolled subjects who met the study eligibility criteria. Note: 3 eligible subjects were randomized in error and were excluded from the Full Analysis Set.

Adverse events

Time frame: Adverse events were collected for the day of visit only for this single visit study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clareon Vivity/Vivity Toric	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
EducationalLink provided by the sponsor.
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.

Clinical Trial Lead, Surgical CRD study director

Alcon Research, LLC

3 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 Extended Vision IOL in people with Astigmatism, run by Alcon Research at 3 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 4 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 13 Jul 2026). 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 Difference in Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 Meters) Before and After Inducing 1.0 Diopter (D) Astigmatism - WTR (time frame: Day 0 before induced astigmatism; Day 0 after induced astigmatism). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06784063.

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 13 Jul 2026.