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

Sponsor
John Berdahl, MD (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04561570
Collaborator
Alcon Research (Industry), Cathleen McCabe, MD (Other), Harvey Reiser, MD (Other), T. Hunter Newsom, MD (Other)
60
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6.4
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Study Group
  • Device: Control Group

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Outcomes of Vivity IOL Versus Control
Actual Study Start Date :
Sep 17, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Study Group: Vivity ACRYSOF IQ IOL

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

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

Outcome Measures

Primary Outcome Measures

  1. Best Corrected Distance Visual Acuity (BCDVAA) [After 1 year post-op]

    Best correct distance visual acuity

  2. Best Corrected Intermediate Visual Acuity (BCIVA) [After 1 year post-op]

    Best correct intermediate visual acuity

  3. Defocus Curve [After 1 year post-op]

Secondary Outcome Measures

  1. Uncorrected Distance Visual Acuity (UCDVA) [After 1 year post-op]

    Uncorrected Distance Visual Acuity

  2. UCNVA [After 1 year post-op]

    Uncorrected Near Visual Acuity

  3. Dyphotopsia rate [After 1 year post-op]

    Demonstrated by responses on questionnaire

  4. Post-operative IOLSAT [After 1 year post-op]

    Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome

  5. (Post-operative QUVID) [After 1 year post-op]

    Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vance Thompson Vision Sioux Falls South Dakota United States 57108

Sponsors and Collaborators

  • John Berdahl, MD
  • Alcon Research
  • Cathleen McCabe, MD
  • Harvey Reiser, MD
  • T. Hunter Newsom, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Berdahl, MD, Principal Investigator, Vance Thompson Vision
ClinicalTrials.gov Identifier:
NCT04561570
Other Study ID Numbers:
  • The REVIVE Study
First Posted:
Sep 23, 2020
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2021