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To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary glaucoma asian patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Cyclo Plasty (UCP) | Experimental | Ultrasound Cyclo Plasty (UCP) using focused ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Cyclo Plasty (UCP) | Device | Cyclocoagulation using High Intensity Focused Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint : reduction of the intraocular pressure | Reduction of the intraocular pressure relative to the preoperative value at each follow-up visits in mmHg and in % of reduction | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: rate of per operative complications | Rate of per-operative device and/or procedure related adverse events | 6 months |
| Safety endpoint: rate of post-operative complications | Rate of post-operative complications during the follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Diseases Prevention and Treatment Center - Department of Ophthalmology | Shanghai | 2000040 | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26547890 | Background | Aptel F, Denis P, Rouland JF, Renard JP, Bron A. Multicenter clinical trial of high-intensity focused ultrasound treatment in glaucoma patients without previous filtering surgery. Acta Ophthalmol. 2016 Aug;94(5):e268-77. doi: 10.1111/aos.12913. Epub 2015 Nov 7. | |
| 31024813 | Background | Torky MA, Al Zafiri YA, Hagras SM, Khattab AM, Bassiouny RM, Mokbel TH. Safety and efficacy of ultrasound ciliary plasty as a primary intervention in glaucoma patients. Int J Ophthalmol. 2019 Apr 18;12(4):597-602. doi: 10.18240/ijo.2019.04.12. eCollection 2019. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 6 months |
| Efficacy endpoint: Number of ocular hypotensive medications | Mean number of IOP lowering medications at each visit during the follow-up period | 6 months |
| E&ENT Fudan University |
| Shanghai |
| China |
| 29043438 | Background | De Gregorio A, Pedrotti E, Stevan G, Montali M, Morselli S. Safety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma. Graefes Arch Clin Exp Ophthalmol. 2017 Dec;255(12):2429-2435. doi: 10.1007/s00417-017-3817-4. Epub 2017 Oct 17. |
| 31125570 | Background | Posarelli C, Covello G, Bendinelli A, Fogagnolo P, Nardi M, Figus M. High-intensity focused ultrasound procedure: The rise of a new noninvasive glaucoma procedure and its possible future applications. Surv Ophthalmol. 2019 Nov-Dec;64(6):826-834. doi: 10.1016/j.survophthal.2019.05.001. Epub 2019 May 22. |
| 29768281 | Background | Giannaccare G, Vagge A, Sebastiani S, Urbini LE, Corazza P, Pellegrini M, Carmassi L, Bergamini F, Traverso CE, Campos EC. Ultrasound Cyclo-Plasty in Patients with Glaucoma: 1-Year Results from a Multicentre Prospective Study. Ophthalmic Res. 2019;61(3):137-142. doi: 10.1159/000487953. Epub 2018 May 16. |
| 30809493 | Background | Pellegrini M, Sebastiani S, Giannaccare G, Campos EC. Intraocular inflammation after Ultrasound Cyclo Plasty for the treatment of glaucoma. Int J Ophthalmol. 2019 Feb 18;12(2):338-341. doi: 10.18240/ijo.2019.02.23. eCollection 2019. |
| 25982212 | Background | 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. |