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AqueSys Microfistula Implant in Refractory Glaucoma

Primary Purpose

Glaucoma, Glaucoma, Open-Angle

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AqueSys Microfistula Implant
Sponsored by
AqueSys, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma Implant, Trabeculectomy, POAG

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vold Vision, PLLC
  • USC Eye Institute, University of Southern California
  • Scripps Clinic
  • Ophthalmic Consultants of Connecticut
  • Bascom Palmer Eye Institute, University of Miami
  • Stiles Eyecare Excellence and Glaucoma Institute
  • Minnesota Eye Consultants, PA
  • Eye Care Associates & Glaucoma Consultants of Long Island
  • New York Eye and Ear Infirmary
  • Vanderbilt Eye Institute
  • Texan Eye
  • Glaucoma Associates of Texas
  • UVA Eye Clinic, University of Virginia
  • Spokane Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AqueSys Microfistula Implant

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications

Secondary Outcome Measures

Mean change in IOP from baseline

Full Information

First Posted
July 12, 2012
Last Updated
January 11, 2016
Sponsor
AqueSys, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01640756
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AqueSys, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open-Angle
Keywords
Glaucoma Implant, Trabeculectomy, POAG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AqueSys Microfistula Implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AqueSys Microfistula Implant
Intervention Description
Placement of the AqueSys Microfistula Implant in the study eye
Primary Outcome Measure Information:
Title
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Mean change in IOP from baseline
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Lewis, M.D.
Organizational Affiliation
Grutzmacher and Lewis Surgical Eye Specialists
Official's Role
Study Chair
Facility Information:
Facility Name
Vold Vision, PLLC
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
USC Eye Institute, University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Ophthalmic Consultants of Connecticut
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Bascom Palmer Eye Institute, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Stiles Eyecare Excellence and Glaucoma Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Minnesota Eye Consultants, PA
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Eye Care Associates & Glaucoma Consultants of Long Island
City
Bethpage
State/Province
New York
ZIP/Postal Code
11714
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Vanderbilt Eye Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texan Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
UVA Eye Clinic, University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Spokane Eye Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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AqueSys Microfistula Implant in Refractory Glaucoma

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