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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-10

Study Completion Date

2025-06-13

Brief Summary

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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.

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Detailed Description

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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

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Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clareon Vivity Extended Vision IOL

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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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

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No