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Intraocular Lens
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
N/A
Waitlist Available
Research Sponsored by Alcon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Awards & highlights
No Placebo-Only Group
Summary
This trial is designed to report the rate of intraocular inflammation following surgery to implant a RESTOR Toric or RESTOR IOL in the US.
Eligible Conditions
- Astigmatism
- Presbyopia
- Aphakia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
Secondary study objectives
Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2
Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2
Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2
+5 moreSide effects data
From 2017 Phase 4 trial • 199 Patients • NCT020066937%
Hyphema
6%
Trabeculectomy
2%
Kidney tumor
1%
Hyponatremia
1%
Intraocular pressure high
1%
Oral cancer stage unspecified
1%
Stomach cancer
1%
Pleural effusion
1%
Cardiac arrest
1%
Heart attack
1%
Cataract aggravated
1%
Retinal disorder
1%
Decompensated cirrhosis
1%
Endophthalmitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
XEN® Gel Stent
XEN® Gel Stent With Cataract Surgery
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment3 Interventions
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in at least one eye during cataract surgery, with implantation occurring after July 2020.
Group II: Cohort 1Experimental Treatment3 Interventions
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery, with implantation occurring from November 2018 through July 2020.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACRYSOF IQ RESTOR +2.5 D Multifocal IOL
2018
N/A
~2450
Cataract Surgery
2010
Completed Phase 4
~5370
ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL
2018
N/A
~2450
ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL
2018
N/A
~2450
Find a Location
Who is running the clinical trial?
Alcon ResearchLead Sponsor
732 Previous Clinical Trials
126,410 Total Patients Enrolled
49 Trials studying Astigmatism
6,661 Patients Enrolled for Astigmatism
Sr. Clinical Trial Lead, CRD SurgicalStudy DirectorAlcon Research
Sr. Clinical Trial Lead, CDMA SurgicalStudy DirectorAlcon Research
7 Previous Clinical Trials
711 Total Patients Enrolled
4 Trials studying Astigmatism
150 Patients Enrolled for Astigmatism