NCT05821101

Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Debbie S. Kuo, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose is to study the clinical outcomes of Clareon Vivity and Clareon Vivity Toric intraocular lens (IOL) implants in patients who are planning to have cataract surgery in both eyes with a mini-monovision approach.

Detailed description

A "mini-monovision" approach is one in which the dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters). This approach can have the benefit of increasing ability to see over a broad range of vision without glasses. The Clareon Vivity and Vivity Toric lenses have been approved by the U.S. Food and Drug Administration (FDA) for visual correction of aphakia in adult patients following cataract surgery. It has lens technology that provides an extended depth of focus (more range of clear vision for distance, intermediate and near vision) compared to a standard monofocal (single focus) lens. None of the procedures in this study are experimental. However, the study is seeking additional information on clinical outcomes of the mini-monovision approach specifically using the Clareon Vivity and Vivity Toric lenses.

Conditions

• Aphakia, Postcataract

Interventions

Type	Name	Description
DEVICE	Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50.	Bilateral implantation of IOLs such that dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters).

Timeline

• Start date: 2023-04-06
• Primary completion: 2025-01-31
• Completion: 2026-06-01
• First posted: 2023-04-20
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study