Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
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A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
1 other identifier
interventional
152
1 country
1
Brief Summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
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
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 23, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedResults Posted
Study results publicly available
December 10, 2019
CompletedDecember 10, 2019
November 1, 2019
4.8 years
December 23, 2013
October 18, 2019
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unmedicated IOP </= 19 mmHg at 12 Months
Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months
12 months
Secondary Outcomes (4)
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
12 & 24 Months
Mean Medication Use at 12 and 24 Months
12 & 24 Months
Unmedicated IOP </= 19 mmHg at 24 Months
24 Months
Unmedicated IOP </= 18 mmHg at 12 Months
12 months
Study Arms (2)
Hydrus Microstent
EXPERIMENTALPatients randomized to the Hydrus Microstent .
iStent Trabecular Micro Bypass
ACTIVE COMPARATORPatients randomized to the iStent Trabecular Micro Bypass
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.
Eligibility Criteria
You may qualify if:
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
- A phakic lens with BCVA of 20/30 or better
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
Study Sites (1)
Contact Richard Hope at Ivantis
Irvine, California, 92618, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Hope
- Organization
- Ivantis, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Julian Garcia Feijoo, Prof. Med.
Madrid, Spain
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 23, 2013
First Posted
December 30, 2013
Study Start
October 1, 2012
Primary Completion
August 1, 2017
Study Completion
January 1, 2018
Last Updated
December 10, 2019
Results First Posted
December 10, 2019
Record last verified: 2019-11