AqueSys Microfistula Implant in Refractory Glaucoma
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma
1 other identifier
interventional
60
1 country
14
Brief Summary
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2012
Typical duration for phase_3
14 active sites
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
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFebruary 8, 2016
January 1, 2016
2.3 years
July 12, 2012
January 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications
12 Months
Secondary Outcomes (1)
Mean change in IOP from baseline
12 Months
Study Arms (1)
AqueSys Microfistula Implant
EXPERIMENTALInterventions
Placement of the AqueSys Microfistula Implant in the study eye
Eligibility Criteria
You may qualify if:
- Diagnosis of Refractory Glaucoma
- Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
- Visual field mean deviation score of -3 dB or worse
- Shaffer Angle Grade ≥ 3
- Area of free, healthy and mobile conjunctiva in the targeted quadrant
You may not qualify if:
- Active Neovascular Glaucoma
- Previous glaucoma shunt/valve in the targeted quadrant
- History of corneal surgery, opacities or disease/pathology
- Anticipated need for ocular surgery
- Non-study eye with BCVA of 20/200 or worse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AqueSys, Inc.lead
Study Sites (14)
Vold Vision, PLLC
Fayetteville, Arkansas, 72704, United States
USC Eye Institute, University of Southern California
Los Angeles, California, 90033, United States
Scripps Clinic
San Diego, California, 92037, United States
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, 06824, United States
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, 33136, United States
Stiles Eyecare Excellence and Glaucoma Institute
Overland Park, Kansas, 66213, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431, United States
Eye Care Associates & Glaucoma Consultants of Long Island
Bethpage, New York, 11714, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
Texan Eye
Austin, Texas, 78731, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
UVA Eye Clinic, University of Virginia
Charlottesville, Virginia, 22903, United States
Spokane Eye Clinic
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Richard A Lewis, M.D.
Grutzmacher and Lewis Surgical Eye Specialists
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 16, 2012
Study Start
July 1, 2012
Primary Completion
November 1, 2014
Study Completion
April 1, 2015
Last Updated
February 8, 2016
Record last verified: 2016-01