CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,449 enrolled
Drug / intervention
ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03733730
NCT03733730N/ACompleted

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

Alcon Research·interventional·Posted Nov 7, 2018·Updated Nov 1, 2023

In Brief

A clinical study evaluating ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL, and 2 other interventions for Aphakia and 2 related conditions. Completed, enrolled 2,449 participants across 38 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 7, 2018
Enrollment StartNov 27, 2018
Primary CompletionOct 14, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.7 years ago

Interventions

ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOLdevice

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.

ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLdevice

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.

ACRYSOF IQ RESTOR +2.5 D Multifocal IOLdevice

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.

Cataract Surgeryprocedure

Routine small incision cataract surgery with IOL implantation