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OpenTrials
Completed

NCT Number: NCT02036541

AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

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

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Key information

Conditions

Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma, Open Angle Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Uveal Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George R. Reiss, MD PC, Glendale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AqueSys XEN 45 Glaucoma Implant

Device

Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AqueSys, Inc.

Industry

Collaborators

  • Allergan

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2014
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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