N/A
Completed N=2,280
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Aphakia · Presbyopia · Astigmatism
Source: ClinicalTrials.gov NCT03733730 ↗
Enrolled (actual)
2,280
Serious AEs
1.1%
Results posted
Nov 2023
Primary outcomePrimary: Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2 — 5.6; 4.5 event rate per 1000 implants
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.
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 | — |
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.
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. Informational only — not medical advice.