NCT04528069

Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population

Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.

Detailed description

Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye. Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months. This study will be conducted in Australia.

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. This device is approved in Australia.
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: 2020-11-16
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2020-08-27
• Last updated: 2022-12-30
• Results posted: 2022-12-30

Locations

4 sites across 1 country: Australia

Regulatory

• FDA-regulated device study