AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

N/ACompletedNCT02036541

AqueSys, Inc.65 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Glaucoma, Open Angle

Interventions

AqueSys XEN 45 Glaucoma ImplantDEVICE

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

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (12)

George R. Reiss, MD PC

Glendale, Arizona, United States

Vold Vision

Fayetteville, Arkansas, United States

Montebello Eye Center

Montebello, California, United States

Outcomes

Primary Outcomes

Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications

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.

Time frame: 12 Months

Mean Change in IOP From Baseline

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.

Time frame: 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.