Vivity Outcomes in Patients With Early Stage Glaucoma (VIVA)

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: Completed
• Conditions: Glaucoma; Cataract; Presbyopia
• Intervention / Treatment: Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	4-6 months
Uncorrected Intermediate Visual Acuity	4-6 months
Uncorrected Near Visual Acuity	4-6 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): November 30, 2022

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): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Extended Range of Vision, Intraocular Lens Technology, Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Refractive Errors; Glaucoma; Cataract; Presbyopia
• 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