Glaucoma, Glaucoma, Open-Angle
Conditions
Keywords
Glaucoma Implant, Trabeculectomy, POAG
Brief summary
To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.
Detailed 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.
Interventions
DEVICEAqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye
Sponsors
AqueSys, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications | 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in IOP from baseline | 12 Months |
Countries
United States
Outcome results
None listed