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临床试验/CTRI/2015/05/005810
CTRI/2015/05/005810已完成未知

Glaucoma treatment using High Intensity Focused Ultrasound (HIFU) in Indian patients with the EyeOP1 medical device

EyeTechCare0 个研究点目标入组 90 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Patients diagnosed with Primary Open Angle Glaucoma or Pseudo-exfoliative Glaucoma or Pigmentary Glaucoma
  • 2. Patients with/without prior filtering glaucoma surgery
  • 3. Patients where the IOP is not adequately controlled with glaucoma medication, with IOP between greater than or equal to 21 mm Hg and less than or equal to 45 mm Hg
  • 4. No previous intraocular surery or laser treatment during the 90 days before HIFU day
  • 5. Patient able and willing to sign approved informed consent form and agrees to attend all postoperative follow-up visits

排除标准

  • 1. Angle closure glaucoma or narrow anatomical anterior chamber as identified by gonioscopy and classified as Shaffer Grade 0 or 1
  • 2. Patients diagnosed with any type of Secondary Glaucoma
  • 3. Glaucoma drainage device implanted and still present in the eye to be treated
  • 4. Previous cyclodestructive procedure in the eye to be treated
  • 5. History of ocular or retrobulbar tumor
  • 6. Ocular infection within 14 days prior to the HIFU procedure
  • 7. Aphakic patient
  • 8. Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP

研究者

发起方
EyeTechCare

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