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Intraocular Lens
Cataract Surgery for Astigmatism
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
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.
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
Study 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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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%
Intraocular pressure high
1%
Hyponatremia
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
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
Cataract Surgery
2010
Completed Phase 4
~5310
ACRYSOF IQ RESTOR +2.5 D Multifocal IOL
2018
N/A
~2450
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
703 Previous Clinical Trials
122,022 Total Patients Enrolled
44 Trials studying Astigmatism
5,995 Patients Enrolled for Astigmatism
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
Sr. Clinical Trial Lead, CRD SurgicalStudy DirectorAlcon Research
Frequently Asked Questions
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