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

July 26, 2023 updated by: John Berdahl, MD

Long Term Outcomes of Vivity IOL Versus Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

45-60 subjects will be enrolled (30-45 subjects that received the Vivity IOL and 15-20 subjects that received the control lens in the FDA clinical trial) across up to five investigational sites.

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group: Vivity ACRYSOF IQ IOL
Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens
Device: Vivity ACRYSOF IQ IOL Group
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
Device: ACRYSOF IQ IOL Control Group
Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Distance Visual Acuity (BCDVAA)
Time Frame: After 1 year post-op
Best correct distance visual acuity
After 1 year post-op
Best Corrected Intermediate Visual Acuity (BCIVA)
Time Frame: After 1 year post-op
Best correct intermediate visual acuity
After 1 year post-op
Defocus Curve
Time Frame: After 1 year post-op
After 1 year post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Distance Visual Acuity (UCDVA)
Time Frame: After 1 year post-op
Uncorrected Distance Visual Acuity
After 1 year post-op
UCNVA
Time Frame: After 1 year post-op
Uncorrected Near Visual Acuity
After 1 year post-op
Dyphotopsia rate
Time Frame: After 1 year post-op
Demonstrated by responses on questionnaire
After 1 year post-op
Post-operative IOLSAT
Time Frame: After 1 year post-op
Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome
After 1 year post-op
(Post-operative QUVID)
Time Frame: After 1 year post-op
Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome
After 1 year post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Berdahl, MD

Collaborators

Alcon Research
The Eye Associates
Eye Care Specialists
NewsomeEye

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2020

Primary Completion (Actual)

April 27, 2021

Study Completion (Actual)

April 27, 2021

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The REVIVE Study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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