NCT04542525

Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.

Detailed description

Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period. This study will be conducted in Japan.

Conditions

• Aphakia
• Corneal Astigmatism

Interventions

Type	Name	Description
DEVICE	ACRYSOF IQ PanOptix Toric Trifocal IOL	Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism
PROCEDURE	Cataract surgery	Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-08-10
• Completion: 2021-08-10
• First posted: 2020-09-09
• Last updated: 2022-08-17
• Results posted: 2022-08-17

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated device study