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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

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 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 groupRoleWhat they receive
Clareon Vivity/Vivity ToricExperimentalPrevious 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted20 Jan 2025
  2. Study start10 Apr 2025
  3. Primary completion13 Jun 2025
  4. Study completion13 Jun 2025

Resources

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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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?
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.

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