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The purpose of this study is to evaluate the effectiveness and the safety of the cyclocoagulation using High Intensity Focused Ulatrsound with the EYEOP1 device in glaucoma patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EYEOP1 device | Experimental | cyclocoagulation HIFU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYEOP1 | Device | Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint : Success / failure rate at 1 year | IOP change (mm Hg and percent) from baseline to 12 months post-HIFU treatment. (Success defined by IOP reduction > 20% compared to the baseline IOP or IOP < 21 mmHg) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measures | Number of device and procedure-related and others complications during follow-up | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent FARCY | EyeTechCare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center | Tel Litwinsky | 52621 | Israel | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25982212 | Result | Melamed S, Goldenfeld M, Cotlear D, Skaat A, Moroz I. High-intensity focused ultrasound treatment in refractory glaucoma patients: results at 1 year of prospective clinical study. Eur J Ophthalmol. 2015 Nov-Dec;25(6):483-9. doi: 10.5301/ejo.5000620. Epub 2015 May 13. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Ospedale San Paolo |
| Milan |
| 20142 |
| Italy |
| Institute Ophthalmology - Universita di Parma | Parma | 43121 | Italy |
| Clinica Oculistica Universitaria - P-O Oftalmico | Torino | 10149 | Italy |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hôpitaux Universitaires de Genève | Geneva | CH-1211 | Switzerland |
| Clinique de Montchoisi - Glaucoma center | Lausanne | CH-1006 | Switzerland |