NCT04561570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2021

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

September 11, 2020

Last Update Submit

July 26, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

  • Best Corrected Distance Visual Acuity (BCDVAA)

    Best correct distance visual acuity

    After 1 year post-op

  • Best Corrected Intermediate Visual Acuity (BCIVA)

    Best correct intermediate visual acuity

    After 1 year post-op

  • Defocus Curve

    After 1 year post-op

Secondary Outcomes (5)

  • Uncorrected Distance Visual Acuity (UCDVA)

    After 1 year post-op

  • UCNVA

    After 1 year post-op

  • Dyphotopsia rate

    After 1 year post-op

  • Post-operative IOLSAT

    After 1 year post-op

  • (Post-operative QUVID)

    After 1 year post-op

Study Arms (2)

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

Control Group: ACRYSOF IQ IOL

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

Device: ACRYSOF IQ IOL Control Group

Interventions

Vivity ACRYSOF IQ IOL GroupDEVICE

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

Study Group: Vivity ACRYSOF IQ IOL
ACRYSOF IQ IOL Control GroupDEVICE

Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens

Control Group: ACRYSOF IQ IOL

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 23, 2020

Study Start

September 17, 2020

Primary Completion

April 27, 2021

Study Completion

April 27, 2021

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

US(1)