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.

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