Study Summary
This trial will evaluate the rate of a type of stent called a Hydrus Microstent malposition and its associated clinical problems that occur within 24 months post-operation.
Eligible Conditions
- Glaucoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 7 Secondary · Reporting Duration: 24 Months
24 Months
Occurrence of clinically significant device malposition
Occurrence of intraoperative ocular adverse events
Occurrence of non-clinically significant device malposition
Occurrence of other postoperative ocular adverse events
Occurrence of sight threatening post-operative adverse events
Day 0 operative
Rate of occurrence of intraoperative ocular adverse events
Month 24
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
Up to 24 Months
Rate of occurrence of clinically significant device malposition associated with clinical sequelae will be assessed
Rate of occurrence of sight threatening post-operative adverse events
Up to Month 24
Rate of occurrence of other postoperative ocular adverse events
Rate of occurrence of sight threatening postoperative adverse events
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Hydrus Microstent
1 of 1
Experimental Treatment
545 Total Participants · 1 Treatment Group
Primary Treatment: Hydrus Microstent · No Placebo Group · N/A
Hydrus MicrostentExperimental Group · 3 Interventions: Cataract surgery, Monofocal IOL, Hydrus Microstent · Intervention Types: Procedure, Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cataract surgery
2014
N/A
~4180
Monofocal IOL
2011
N/A
~290
Hydrus Microstent
2011
N/A
~460
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Who is running the clinical trial?
Alcon ResearchLead Sponsor
660 Previous Clinical Trials
116,877 Total Patients Enrolled
145 Trials studying Glaucoma
27,159 Patients Enrolled for Glaucoma
Ivantis, Inc.Lead Sponsor
6 Previous Clinical Trials
1,846 Total Patients Enrolled
6 Trials studying Glaucoma
1,846 Patients Enrolled for Glaucoma
Clinical Project Lead, CDMA SurgicalStudy DirectorAlcon Research
1 Previous Clinical Trials
585 Total Patients Enrolled
1 Trials studying Glaucoma
585 Patients Enrolled for Glaucoma
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are suffering from an age-related cataract with a BCVA of 20/40 or poorer.
You have been diagnosed with primary open angle glaucoma and are utilizing no more than four topical treatments.
Your optic nerve presents the signs of glaucoma.
Your intraocular pressure (IOP) is below 31 mmHg, and you meet any other requirements stipulated by the protocol.
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Conditions
Cancer Related
Treatments