Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery
A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
1 other identifier
interventional
306
0 countries
N/A
Brief Summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 20, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
June 21, 2024
CompletedJuly 3, 2024
June 1, 2024
5.6 years
December 20, 2013
February 19, 2024
June 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
Month 12: 8 am, 12 pm, 4 pm
Secondary Outcomes (2)
Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12
Month 12: 8 am, 12 pm, and 4 pm
Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12
Month 12: 8 am, 12 pm, 4 pm
Study Arms (2)
Hydrus Microstent
EXPERIMENTALCataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)
iStent
ACTIVE COMPARATORCataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Interventions
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects
Eligibility Criteria
You may qualify if:
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
- An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.
You may not qualify if:
- Forms of primary or secondary glaucoma not listed above
- Prior glaucoma surgery in the study eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ivantis, Inc.lead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, CDMA Surgical
- Organization
- Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2013
First Posted
December 31, 2013
Study Start
August 1, 2011
Primary Completion
March 1, 2017
Study Completion
August 1, 2018
Last Updated
July 3, 2024
Results First Posted
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share