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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04561570
Other study ID # The REVIVE Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 17, 2020
Est. completion date April 27, 2021

Study information

Verified date July 2023
Source Vance Thompson Vision
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date April 27, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Must have participated in the FDA study at one of the included sites Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Vance Thompson Vision Sioux Falls South Dakota

Sponsors (5)

Lead Sponsor Collaborator
John Berdahl, MD Alcon Research, Eye Care Specialists, NewsomeEye, The Eye Associates

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best Corrected Distance Visual Acuity (BCDVAA) Best correct distance visual acuity After 1 year post-op
Primary Best Corrected Intermediate Visual Acuity (BCIVA) Best correct intermediate visual acuity After 1 year post-op
Primary Defocus Curve After 1 year post-op
Secondary Uncorrected Distance Visual Acuity (UCDVA) Uncorrected Distance Visual Acuity After 1 year post-op
Secondary UCNVA Uncorrected Near Visual Acuity After 1 year post-op
Secondary Dyphotopsia rate Demonstrated by responses on questionnaire After 1 year post-op
Secondary Post-operative IOLSAT Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome After 1 year post-op
Secondary (Post-operative QUVID) Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome After 1 year post-op
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