AqueSys Microfistula Implant in Refractory Glaucoma

Sponsor

AqueSys, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01640756

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Glaucoma, Open-Angle	Device: AqueSys Microfistula Implant	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AqueSys Microfistula Implant	Device: AqueSys Microfistula Implant Placement of the AqueSys Microfistula Implant in the study eye

Arm

Intervention/Treatment

Experimental: AqueSys Microfistula Implant

Device: AqueSys Microfistula Implant

Placement of the AqueSys Microfistula Implant in the study eye

Outcome Measures

Primary Outcome Measures

Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications [12 Months]

Secondary Outcome Measures

Mean change in IOP from baseline [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vold Vision, PLLC	Fayetteville	Arkansas	United States	72704
2	USC Eye Institute, University of Southern California	Los Angeles	California	United States	90033
3	Scripps Clinic	San Diego	California	United States	92037
4	Ophthalmic Consultants of Connecticut	Fairfield	Connecticut	United States	06824
5	Bascom Palmer Eye Institute, University of Miami	Miami	Florida	United States	33136
6	Stiles Eyecare Excellence and Glaucoma Institute	Overland Park	Kansas	United States	66213
7	Minnesota Eye Consultants, PA	Bloomington	Minnesota	United States	55431
8	Eye Care Associates & Glaucoma Consultants of Long Island	Bethpage	New York	United States	11714
9	New York Eye and Ear Infirmary	New York	New York	United States	10003
10	Vanderbilt Eye Institute	Nashville	Tennessee	United States	37232
11	Texan Eye	Austin	Texas	United States	78731
12	Glaucoma Associates of Texas	Dallas	Texas	United States	75231
13	UVA Eye Clinic, University of Virginia	Charlottesville	Virginia	United States	22903
14	Spokane Eye Clinic	Spokane	Washington	United States	99204