VIVA: Vivity Outcomes in Patients With Early Stage Glaucoma

Sponsor
Vance Thompson Vision (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04670575
Collaborator
(none)
25
Enrollment
1
Location
7
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Vivity Outcomes in Patients With Early Stage Glaucoma
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Uncorrected Distance Visual Acuity [4-6 months]

  2. Uncorrected Intermediate Visual Acuity [4-6 months]

  3. Uncorrected Near Visual Acuity [4-6 months]

Secondary Outcome Measures

  1. Contrast Sensitivity [4-6 months]

    As measured by Pelli Robson Chart

  2. Patient Satisfaction and Spectacle Independence Survey Results [4-6 months]

  3. Mean Refractive Spherical Equivalent [4-6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vance Thompson VisionSioux FallsSouth DakotaUnited States57108

Sponsors and Collaborators

  • Vance Thompson Vision

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vance Thompson Vision
ClinicalTrials.gov Identifier:
NCT04670575
Other Study ID Numbers:
  • VIVA
First Posted:
Dec 17, 2020
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Vance Thompson Vision
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2020