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Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma.
Clinical trial multicenter, phase III,open-label, prospective character to evaluate the efficacy and safety of Susanna Implant in patients with refractory glaucoma of both genders, of any race, aged above 18 years and diagnosed with glaucoma refractory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Susanna Implant | No Intervention | Patients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Susanna Implant | Device | device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. | Evaluate the effectiveness of implant susanna in patients with refractory glaucoma. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. " | Evaluate the safety of implant susanna in patients with refractory glaucoma. i | 180 days |
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Inclusion Criteria:
Neovascular glaucoma group:
Group post-trabeculectomy failure:
Exclusion Criteria:
Group post-trabeculectomy failure:
Neovascular glaucoma group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Augusto Paranhos, Investigator | Contact | 55 11 3747-3312 | ||
| Fernanda Lima, Coordinator | Contact | 55 11 2151-0723 | fernandalima@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| Remo Susanna, Investigator | Hospital das Clínicas de São Paulo | Principal Investigator |
| Renato Lisboa, Investigator | UNIFESP - Universidade Federal de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | 05651-901 | Brazil |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Cláudia Galvão, Investigator |
| Hospital Universitário Prof. Edgar Santos - BA |
| Principal Investigator |
| Flávia Villas, Investigator | - Instituto brasileiro de Oftalmologia e prevenção da cegueira- BA | Principal Investigator |
| Fábio Kanadani, Investigator | Hospital Universitário São José - Belo Horizonte | Principal Investigator |
| Augusto Paranhos, Investigator | Hospital Israelita Albert Einstein | Principal Investigator |