NCT05464732

Vivity IOL: Emmetropia Compared to Monovision.

Visual Outcomes, Patient Satisfaction and Spectacle Independence Evaluation of the Acrysof® IQ Vivity® Intraocular Lens Targeted for Emmetropia or Nanovision.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Carolina Eyecare Physicians, LLC · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is concerned with the visual performance of the Vivity Extended Vision IOL at distance, intermediate and near when one of the eyes is targeted for emmetropia and the other is targeted for slight myopia. Patients will serve as their own controls with visual performance evaluated against corrected vision with a target of emmetropia in both eyes.

Conditions

• Presbyopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-03
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2022-07-19
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study