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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first for reporting.

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 more

Side effects data

From 2017 Phase 4 trial • 199 Patients • NCT02006693

Hyphema

Trabeculectomy

Kidney tumor

Hyponatremia

Intraocular pressure high

Oral cancer stage unspecified

Stomach cancer

Pleural effusion

Cardiac arrest

Heart attack

Cataract aggravated

Retinal disorder

Decompensated cirrhosis

Endophthalmitis

100%

80%

60%

40%

20%

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