AqueSys Microfistula Implant in Refractory Glaucoma

AqueSys, Inc.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Glaucoma, Open-Angle

Interventions

AqueSys Microfistula ImplantDEVICE

Placement of the AqueSys Microfistula 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 (14)

Vold Vision, PLLC

Fayetteville, Arkansas, United States

USC Eye Institute, University of Southern California

Los Angeles, California, United States

Scripps Clinic

Outcomes

Primary Outcomes

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

Secondary Outcomes

Mean change in IOP from baseline

Time frame: 12 Months

Data from ClinicalTrials.gov

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