Vivity Outcomes in Patients With Early Stage Glaucoma

NCT ID: NCT04670575

Last Updated: 2024-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Glaucoma Cataract Presbyopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vivity

Patients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery.

Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

Intervention Type PROCEDURE

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

Interventions

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Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vance Thompson Vision

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian M Shafer, MD

Role: PRINCIPAL_INVESTIGATOR

Vance Thompson Vision

Locations

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Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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VIVA

Identifier Type: -

Identifier Source: org_study_id

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