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To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.
CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadence | Experimental | Cadence procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadence implant | Device | CADENCE Glaucoma Drainage Device System is a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of AEs | comparison of intra-operative and post-operative adverse events observed to events reported in published literature, | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Experience Evaluation | An evaluation of the surgical experience using feedback questionnaire to describe specific note of performance characteristics of each implant. | 12 months |
| Change in IOP |
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Inclusion Criteria:
Exclusion Criteria:
Women of child-bearing potential
Intraocular surgery or laser within the last 3 months
Ocular infection or inflammation within the last 6 months or currently active
Current use of anti-coagulant therapy
History of bleeding disorder or coagulopathies
Subject plans to undergo any ocular surgery (including cataract surgery) during the study period
History of corneal transplantation
History of ICE Syndrome or epithelial ingrowth/downgrowth
History of congenital glaucoma
Elevated episcleral venous pressure
-. Persistent angle closure-
Previous glaucoma filtration surgery- -Presence of conjunctival scarring -
neovascular glaucoma
AC lens or scleral sutured IOL
Aphakia
inability to DC contact lenses
Presence of intraocular silicone oil
Vitreous in AC
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sun, PhD | New World Medical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Laser y Ultrasonido Ocular de Puebla | Puebla City | 72530 | Mexico |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Open Label
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Change in IOP from Screening to M12
| 12 months |
| Change in IOP Lowering Medications | Change in IOP lowering medications from Screening to M12 | 12 months |