Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

NCT ID: NCT06541795

Last Updated: 2025-09-15

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.

Detailed Description

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This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.

This study will be conducted in the US and in Spain.

Conditions

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Aphakia Presbyopia Residual Refractive Cylinder

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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AcrySof IQ Vivity Extended Vision IOL and AcrySof IQ Vivity Toric Extended Vision IOL

AcrySof IQ Vivity Extended Vision IOL implanted in both eyes during cataract surgery

Group Type EXPERIMENTAL

AcrySof IQ Vivity Extended Vision IOL

Intervention Type DEVICE

UV-absorbing, with or without blue light filtering, foldable IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients from whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing an extended depth of focus. The toric models in addition reduce residual refractive astigmatism in patients with pre-existing corneal astigmatism.

Interventions

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AcrySof IQ Vivity Extended Vision IOL

UV-absorbing, with or without blue light filtering, foldable IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients from whom a cataractous lens has been removed. The IOL mitigates the effects of presbyopia by providing an extended depth of focus. The toric models in addition reduce residual refractive astigmatism in patients with pre-existing corneal astigmatism.

Intervention Type DEVICE

Other Intervention Names

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AcrySof IQ Vivity Extended Vision IOL: Model DFT015 AcrySof IQ Vivity Extended Vision UV Absorbing IOL: Model DAT015 AcrySof IQ Vivity Toric Extended Vision IOL: Models DFT215, DFT315, DFT415, DFT515 and DFT615 according to country of conduct AcrySof IQ Vivity Toric Extended Vision UV Absorbing IOL: Models DAT315, DAT415, DAT515 and DAT615 according to country of conduct

Eligibility Criteria

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Inclusion Criteria

* 22 years old or older at Visit 1.
* Able to understand and sign an approved informed consent form.
* Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
* Documented medical history and required pre-operative baseline information available for retrospective data collection.

Exclusion Criteria

* Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
* Pregnant or nursing at the time of enrollment.
* Childbirth after IOL implantation.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management Operations, Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ILI875-I001

Identifier Type: -

Identifier Source: org_study_id

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