CTRI/2009/091/001027Other未知
Evaluation of the Safety of AquaLase® Liquefacture Device Treatment of the Trabecular Meshwork(C-09-027)
试验速览
- 阶段
- 未知
- 状态
- Other
- 入组人数
- 4
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)At least 18 years old and of legal age to consent
- •2)Able and willing to sign informed consent form
- •3)Able, healthy and willing to attend follow-up visits for 1 month after procedure
- •4)Best corrected visual acuity worse than or equal to 6/120 (20/400) in study eye
- •5)Best corrected visual acuity better than or equal to 6/60 (20/200) in fellow eye
- •6)Permanent non-recoverable vision loss in study eye due to POAG and/or ARMD
- •7)Grade III or IV Schaeffer Scale open angle on gonioscopy, without PAS or recession
- •12 mmHg < IOP < 36 mmHg
- •8)If taking glaucoma medications, stable dose for 6 weeks and able to continue medications
- •throughout study
排除标准
- •1)Any prior intraocular or refractive surgery
- •2)Any form of glaucoma other than Primary Open Angle Glaucoma
- •3)Primary or secondary angle closure
- •4)Limited or obstructed view of angle, cornea or fundus preventing application of therapy or required
- •observations / measurements
- •5)Any angle with PAS or new vessels on gonioscopy
- •Corneal abnormalities, including Fuch?s Dystrophy, that would preclude accurate IOP readings by
- •applanation tonometery and specular microscopy
- •6)Uncontrolled systemic disease based on medical history
- •7)Central Corneal Endothelial Cell Count 1800 cells / mm2
- •8)Any other active or recently resolved ocular disease, e.g., uveitis or ocular infection
- •9)History of persistent or recurring ocular inflammation
- •10)Any current, clinically significant, progressive retinal disease including pre-proliferative or
- •proliferative diabetic retinopathy
- •11)Any current or past use of any alpha-1-selective adrenoceptor blocking agent or an antagonist of
- •alpha 1 A adrenoceptor, such as Flomax®, Cardura®, or Hytrin®
- •12)Known hypersensitivity to any treatment component of this procedure
- •13)Women who are pregnant, intend to become pregnant during the study period, are not using highly
- •effective birth control measures or are breast-feeding
- •14)Current participation in another clinical trial
研究者
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