NCT04800016

Real-World Study of Vivity Intraocular Lenses (IOLs)

Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.

Detailed description

In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 13 months. This study will be conducted in China.

Conditions

• Aphakia
• Presbyopia

Interventions

Type	Name	Description
DEVICE	AcrySof IQ Vivity Extended Vision IOL	UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
PROCEDURE	Cataract surgery	Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-01-01
• Completion: 2024-07-01
• First posted: 2021-03-16
• Last updated: 2023-08-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study