Clinical trial NCT01640756: AqueSys Microfistula Implant in Refractory Glaucoma
Official title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Glaucoma, Open-Angle
Keywords: Glaucoma Implant
Trabeculectomy
POAG
Lead sponsor: AqueSys, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.

Detailed description: A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications
timeFrame: 12 Months
Secondary outcomes:
measure: Mean change in IOP from baseline
timeFrame: 12 Months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision, PLLC
state: Arkansas
city: Los Angeles
country: United States
facility: USC Eye Institute, University of Southern California
state: California
city: San Diego
country: United States
facility: Scripps Clinic
state: California
city: Fairfield
country: United States
facility: Ophthalmic Consultants of Connecticut
state: Connecticut
city: Miami
country: United States
facility: Bascom Palmer Eye Institute, University of Miami
state: Florida
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence and Glaucoma Institute
state: Kansas
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, PA
state: Minnesota
city: Bethpage
country: United States
facility: Eye Care Associates & Glaucoma Consultants of Long Island
state: New York
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Charlottesville
country: United States
facility: UVA Eye Clinic, University of Virginia
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
Study officials:
affiliation: Grutzmacher and Lewis Surgical Eye Specialists
name: Richard A Lewis, M.D.
role: STUDY_CHAIR
References: