Skip to main content
OpenTrials
Completed

NCT Number: NCT04670575

Vivity Outcomes in Patients With Early Stage Glaucoma

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension Presbyopia Refractive Errors

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Who can participate

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

Procedure

Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL

Primary outcomes

  1. Uncorrected Distance Visual Acuity

    Time frame: 4-6 months

  2. Uncorrected Intermediate Visual Acuity

    Time frame: 4-6 months

  3. Uncorrected Near Visual Acuity

    Time frame: 4-6 months

Secondary outcomes

  1. Contrast Sensitivity

    Time frame: 4-6 months

    As measured by Pelli Robson Chart

  2. Patient Satisfaction and Spectacle Independence Survey Results

    Time frame: 4-6 months

  3. Mean Refractive Spherical Equivalent

    Time frame: 4-6 months

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Registry information

Acronym: VIVA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
May 20, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.