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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Clareon Vivity Extended Vision IOL

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;
• BCDVA of 0 logMAR or better in each eye.

Exclusion Criteria:

• Residual astigmatism greater than or equal to 1.00 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Clareon Vivity/Vivity Toric; 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.

Device: Clareon Vivity Extended Vision 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.; Other Names: Clareon Vivity™ Extended Vision Hydrophobic IOL; 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 Toric IOL; Clareon Vivity™ UV Absorbing IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - WTR	BCDVA will be 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 will be 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 will be measured 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 will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.	Day 0, coinciding with IOL implantation at least 4 months prior to visit
Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism - WTR	DCIVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.	Day 0, coinciding with IOL implantation at least 4 months prior to visit
Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - WTR	DCNVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.	Day 0, coinciding with IOL implantation at least 4 months prior to visit
Mean difference in monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters) before and after inducing 1.0 diopter (D) astigmatism - ATR	BCDVA will be assessed with best refractive correction in place at a distance of 4 m using ETDRS letter charts. Trial lenses will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.	Day 0, coinciding with IOL implantation at least 4 months prior to visit
Mean difference in monocular Distance Corrected Intermediate Visual Acuity (DCIVA) (66 centimeters) before and after inducing 1.0 D astigmatism.- ATR	DCIVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.	Day 0, coinciding with IOL implantation at least 4 months prior to visit
Mean difference in monocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) before and after inducing 1.0 D astigmatism - ATR	DCNVA will be 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 will be 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 will be measured in logMAR, with a lower logMAR value indicating better visual acuity. The change in VA before and after inducing astigmatism will be reported. One eye (first implanted eye) will be assessed. This is a co-primary endpoint.	Day 0, coinciding with IOL implantation at least 4 months prior to visit

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Surgical CRD, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cataract; IOL
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: ILE632-C003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No