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OpenTrials
Completed

NCT Number: NCT04561570

Long Term Outcomes of Vivity Intra Ocular Lens(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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Vivity ACRYSOF IQ IOL Group

Device

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

ACRYSOF IQ IOL Control Group

Device

Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens

Primary outcomes

  1. Best Corrected Distance Visual Acuity (BCDVAA)

    Time frame: After 1 year post-op

    Best correct distance visual acuity

  2. Best Corrected Intermediate Visual Acuity (BCIVA)

    Time frame: After 1 year post-op

    Best correct intermediate visual acuity

  3. Defocus Curve

    Time frame: After 1 year post-op

Secondary outcomes

  1. Uncorrected Distance Visual Acuity (UCDVA)

    Time frame: After 1 year post-op

    Uncorrected Distance Visual Acuity

  2. UCNVA

    Time frame: After 1 year post-op

    Uncorrected Near Visual Acuity

  3. Dyphotopsia rate

    Time frame: After 1 year post-op

    Demonstrated by responses on questionnaire

  4. 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

  5. (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

Sponsors and collaborators

Lead sponsor

John Berdahl, MD

Other

Collaborators

  • Alcon Research
  • Eye Care Specialists
  • NewsomeEye
  • The Eye Associates

Registry information

Official study title

Long Term Outcomes of Vivity IOL Versus Control

Acronym: REVIVE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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