AqueSys Microfistula Implant in Refractory Glaucoma

AqueSys

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Glaucoma, Open-Angle

Treatments: Device: AqueSys Microfistula Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01640756

P11-001

Details and patient eligibility

About

To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

AqueSys Microfistula Implant

Experimental group

Treatment:

Device: AqueSys Microfistula Implant