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Trial record 1 of 4 for:    aquesys
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AqueSys Microfistula Implant in Refractory Glaucoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640756
First Posted: July 16, 2012
Last Update Posted: February 8, 2016
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.
Information provided by (Responsible Party):
AqueSys, Inc.
July 12, 2012
July 16, 2012
February 8, 2016
July 2012
November 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01640756 on ClinicalTrials.gov Archive Site
Mean change in IOP from baseline [ Time Frame: 12 Months ]
Same as current
Not Provided
Not Provided
 
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
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Glaucoma
  • Glaucoma, Open-Angle
Device: AqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye
Experimental: AqueSys Microfistula Implant
Intervention: Device: AqueSys Microfistula Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2015
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01640756
P11-001
No
Not Provided
Not Provided
AqueSys, Inc.
AqueSys, Inc.
Not Provided
Study Chair: Richard A Lewis, M.D. Grutzmacher and Lewis Surgical Eye Specialists
AqueSys, Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP