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Vivity IOL: Emmetropia Compared to Monovision.

NCT05464732 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-03-24

Study results available
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Summary

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Different options are available including: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocal, trifocal and extended depth of focus (EDOF) IOLs. The Vivity Extended Vision IOL is not a multifocal IOL but due to its design, it provides better intermediate and near VA compared to a monofocal IOL.

Conditions

Interventions

DEVICE

Vivity IOL emmetropia

The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to bilateral emmetropia.

DEVICE

Vivity IOL monovision

The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to emmetropia in the dominant eye and -0.50 in the non-dominant eye.

Sponsors & Collaborators

  • Science in Vision

    collaborator OTHER

  • Carolina Eyecare Physicians, LLC

    lead OTHER

Principal Investigators

  • Kerry Solomon · Carolina Eyecare Physicians, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2022-08-30
Completion
2022-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464732 on ClinicalTrials.gov