NCT03733730

Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,449 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.

Detailed description

If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 20 days of the first eye surgery. Four postoperative follow-up visits are planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. Subject participation in this study is expected to last up to 7 months, including a total of 6 study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the study.

Conditions

• Aphakia
• Presbyopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL	Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
DEVICE	ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL	Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
DEVICE	ACRYSOF IQ RESTOR +2.5 D Multifocal IOL	Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
PROCEDURE	Cataract Surgery	Routine small incision cataract surgery with IOL implantation

Timeline

• Start date: 2018-11-27
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2018-11-07
• Last updated: 2023-11-01
• Results posted: 2023-11-01

Locations

38 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated device study