AqueSys Microfistula Implant in Refractory Glaucoma
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | April 2015 |
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.
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.
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
We found this trial at
14
sites
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