NCT05852470

Evaluation of Clareon Vivity/Vivity Toric

PMCF (Post Market Clinical Follow-up) Evaluation of Clareon Vivity/Vivity Toric

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.

Detailed description

Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.

Conditions

• Aphakia

Interventions

Type	Name	Description
DEVICE	Clareon Vivity/Vivity Toric Extended Vision IOL	Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
DEVICE	Clareon Monofocal/Clareon Toric IOL	Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.

Timeline

• Start date: 2023-05-23
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2023-05-10
• Last updated: 2026-02-24
• Results posted: 2024-11-05

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study