Long Term Outcomes of Vivity Intra Ocular Lens(IOL) Versus Control

NCT ID: NCT04561570

Last Updated: 2023-08-01

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

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-17

Study Completion Date

2021-04-27

Brief Summary

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Evaluate the long-term (\>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.

Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group: Vivity ACRYSOF IQ IOL

Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens

Vivity ACRYSOF IQ IOL Group

Intervention Type DEVICE

Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens

Control Group: ACRYSOF IQ IOL

Control Group: Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens

ACRYSOF IQ IOL Control Group

Intervention Type DEVICE

Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens

Interventions

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Vivity ACRYSOF IQ IOL Group

Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens

Intervention Type DEVICE

ACRYSOF IQ IOL Control Group

Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Must have participated in the FDA study at one of the included sites

Exclusion Criteria

None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

The Eye Associates

OTHER

Sponsor Role collaborator

Eye Care Specialists

UNKNOWN

Sponsor Role collaborator

NewsomeEye

UNKNOWN

Sponsor Role collaborator

John Berdahl, MD

OTHER

Sponsor Role lead

Responsible Party

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John Berdahl, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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The REVIVE Study

Identifier Type: -

Identifier Source: org_study_id

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