临床治疗结果

世界各地的医疗团队针对UCP技术展开了大规模临床研究,为论证UCP技术的安全性以及有效性提供了大量可靠数据。

有效性

UCP技术已在全世界范围内治疗超过10 000名患者

术后12个月内眼压平均降低

基于6扇区治疗结果

术后12个月内的成功率为70%
 

*术后成功的标准:在无需新增降压药物的前提下,患者眼压下降幅度> 20%, 术后眼压> 5 mmHg,

有效性–重复治疗

UCP治疗成功标准:术后眼压<20%
针对有需要的患者,重复治疗在术后4个月进行
试验对象:40名患者, 35%开角型青光眼, 42%接受过滤过性手术, 65%非开角型患者, 7.5%闭角型患者, 20%剥脱性青光眼, 30%新生血管型青光眼, 7.5%其他类型

资料来源:Safety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma – Dra De Gregorio & All – Graefe’s Archives for clinical and experimental ophthalmology – October 2017

安全性

众多临床研究显示UCP技术良好的安全性,未出现严重不良反应

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临床研究

Glaucoma treatment with high intensity focused ultrasound – results at 3 years for a population of 104 patient
Rouland JF, Aptel F, SFO 2019, poster # 245

  • 104名未经手术治疗的患者,36个月的跟踪随访,前瞻性多中心研究
  • 术后36个月的成功率为55%
  • 眼压基线为27.6 +/- 8.9 mmHg,术后平均眼压下降33%

Ultrasound cyclo plasty in surgery naïve open angle glaucoma patients. Interim month -18 results of a prospective multicenter clinical trial
Pinto L. et al., WGC 2019, poster # 1312

  • 66名未经手术治疗的患者,18个月随访,前瞻性多中心研究
  • 术后12个月治疗成功率为70%
  • 眼压基线为24.3 +/- 2.9 mmHg,平均眼压下降34%

Safety and efficacy of ultrasound ciliary plasty as a primary intervention in glaucoma patients
Torky M. et al., International Journal of ophthalmology 2019

  • 62名未经手术治疗的患者,12个月的跟踪随访,前瞻性多中心研究
  • 术后12个月的成功率为77%
  • 眼压基线为35.2 +/- 8.3 mmHg,平均降压幅度42%

Application of high intensity focused ultrasound for treatment of open-angle glaucoma In Indian patients
Deb N. et al., Indian journal of ophthalmology 2019

  • 73名未经手术的患者,12个月随访,前瞻性单中心研究 
  • 术后12个月的成功率为78%
  • 眼压基线为23.5 +/-3 mmHg,平均降压幅度30%

High intensity focused ultrasound for glaucoma – one year results from a prospective pragmatic study
Sousa D. et al., WGC 2019, poster # P-FS-116

  • 51名难治性青光眼或未经手术治疗的患者,12个月的随访,前瞻性多中心研究 
  • 术后12个月的成功率为80%
  • 眼压基线为26.7 +/- 7.7 mmHg,术后平均眼压下降33%

Ultrasound cycloplasty in patients with glaucoma: 1 year results from a multicenter prospective study
Giannaccare G., Traverso C. et al., Ophthalmic Research Journal 2018

  • 49名难治性青光眼患者,12个月随访,前瞻性多中心研究
  • 术后12个月治疗成功率为75%
  • 眼压基线为27.7 +/- 9.2 mmHg,平均眼压下降30%

Ultrasound cyclo plasty for treatment of surgery naïve open angle glaucoma patients. Interim results at 1 year of a prospective multicenter clinical trial
Figus M. et al., EGS 2018, Poster # P4-072

  • 66名未经手术治疗的患者,12个月随访,前瞻性多中心研究
  • 手术成功率65%
  • 眼压基线为24.3 +/-2.9mmHg,平均眼压下降31%

Safety and efficacy of multiple cyclocoagulation of ciliary bodies by high-intensity focused ultrasound in patients with glaucoma
De Gregorio A. et al., Graefes Arch Clin Exp Ophthalmol 2017

  • 40名难治性青光眼或未经手术治疗的患者,12个月随访,前瞻性单中心研究
  • 针对病情复杂的患者(35%开角型青光眼),接受最后一次治疗12个月后,治疗的成功率为85%,初次治疗效果不理想的患者统一在术后4个月接受重复治疗
  • 眼压基线为32.5 +/-9.9mmHg,眼压平均降低35%

High-intensity focused ultrasound cyclo-coagulation
Sousa D. et al., AAO 2017, Poster # 368

  • 46名难治性青光眼或未经手术治疗的患者,12个月随访,前瞻性多中心研究
  • 治疗成功率79%
  • 眼压基线27.2 +/-7.9mmHg,眼压平均下降34%