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AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02036541
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
AqueSys, Inc.

Brief Summary:
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma Glaucoma, Open Angle Device: AqueSys XEN 45 Glaucoma Implant Not Applicable

Detailed Description:
A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 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 XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
Study Start Date : January 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: AqueSys XEN 45 Glaucoma Implant Device: AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye

Primary Outcome Measures :
  1. 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 ]
    Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.

  2. Mean Change in IOP From Baseline [ Time Frame: 12 Months ]
    Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02036541

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United States, Arizona
George R. Reiss, MD PC
Glendale, Arizona, United States, 85306
United States, Arkansas
Vold Vision
Fayetteville, Arkansas, United States, 72704
United States, California
Montebello Eye Center
Montebello, California, United States, 90640
San Diego Eye Care Center
Oceanside, California, United States, 92056
Palo Alto Eye Group
Palo Alto, California, United States, 94306
United States, Colorado
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80525
United States, Kansas
Stiles Eyecare Excellence & Glaucoma Institute
Overland Park, Kansas, United States, 66213
United States, Missouri
Washington University in St. Louis, Department of Ophthalmology
Saint Louis, Missouri, United States, 63110
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
R and R Eye Research, LLC
San Antonio, Texas, United States, 78229
United States, Washington
Spokane Eye Clinic
Spokane, Washington, United States, 99204
Sponsors and Collaborators
AqueSys, Inc.
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Study Chair: Richard A Lewis, M.D. Grutzmacher, Lewis & Sierra Surgical Eye Specialists
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AqueSys, Inc. Identifier: NCT02036541    
Other Study ID Numbers: P13-001
First Posted: January 15, 2014    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Keywords provided by AqueSys, Inc.:
Glaucoma Implant
Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Pigmentary Glaucoma
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases