Vivity Outcomes in Patients With Early Stage Glaucoma (VIVA)

December 13, 2020 updated by: Vance Thompson Vision
The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with early stage glaucoma with cataracts in both eyes who are planned to have bilateral cataract surgery with implantation of Vivity or Vivity Toric intraocular lens.

Description

Inclusion Criteria:

  1. Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS)
  2. Subjects with documented diagnosis of pre-perimetric glaucoma
  3. Calculated lens power within Vivity/Vivity toric range
  4. Willing and able to comprehend informed consent and complete 4-6 month post-op visit
  5. Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

Exclusion Criteria:

  1. Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA
  2. Previous ocular surgery including refractive surgery
  3. Subjects who are pregnant or plan to become pregnant during the course of the study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vivity
Patients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery.
Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL
Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Uncorrected Distance Visual Acuity
Time Frame: 4-6 months
4-6 months
Uncorrected Intermediate Visual Acuity
Time Frame: 4-6 months
4-6 months
Uncorrected Near Visual Acuity
Time Frame: 4-6 months
4-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast Sensitivity
Time Frame: 4-6 months
As measured by Pelli Robson Chart
4-6 months
Patient Satisfaction and Spectacle Independence Survey Results
Time Frame: 4-6 months
4-6 months
Mean Refractive Spherical Equivalent
Time Frame: 4-6 months
4-6 months

Collaborators and Investigators

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

Sponsor

Vance Thompson Vision

Investigators

  • Principal Investigator: Brian M Shafer, MD, Vance Thompson Vision

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 (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 13, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 13, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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