N/A N=2,280 Treatment

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

Aphakia · Presbyopia · Astigmatism

Bottom Line

View on ClinicalTrials.gov: NCT03733730 ↗

Enrolled (actual)

2,280

Serious AEs

1.1%

Results posted

Nov 2023

Primary outcome: Primary: Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 — 5.6; 4.5 event rate per 1000 implants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL (Device); ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL (Device); ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Device); Cataract Surgery (Procedure)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2	5.6; 4.5	—
PRIMARY Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2	5.1	—
SECONDARY Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2	1.1; 0.0	—
SECONDARY Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2	0.6	—
SECONDARY Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2	0.0; 0.6	—
SECONDARY Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2	0.3	—
SECONDARY Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2	0.0; 0.0	—
SECONDARY Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2	0.0	—
SECONDARY Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2	4.5; 3.8	—
SECONDARY Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2	4.2	—

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.

Eligibility Criteria

Inclusion Criteria

Preoperative cataract in the study eye(s)
Planned implantation in at least one eye with:
Cohort 1: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling from November 2018 to July 2020
Cohort 2: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 2020.
Able to comprehend and sign a statement of informed consent
Willing and able to complete all required postoperative visits
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

Eyes with clinically significant ocular, including adnexa, or intraocular infection or inflammation (at the screening visit prior to surgery or on the day of surgery)
History of any intraocular inflammation within the past 12 months (ex: uveitis, choroiditis)
Combined procedures introducing an additional medical device during cataract surgery (ex: cataract surgery with implant of glaucoma stent)
Other protocol-specified exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03733730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.