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临床试验/PACTR201208000401104
PACTR201208000401104招募中未知

THE Ex-PRESS MINI SHUNT VERSUS TRABECULECTOMY IN AFRICAN PATIENTS: A RANDOMIZED CONTROLLED TRIA

ALCON LABORATORIES INC.0 个研究点目标入组 60 人开始时间: 2012年7月26日最近更新:

试验速览

阶段
未知
状态
招募中
入组人数
60

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

年龄范围
18 Year(s) 至 90 Year(s)(—)
性别
All

入选标准

  • Age 18 to 90 years, inclusive.
  • Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure > 18 mm Hg and < 40mm Hg.
  • Glaucoma drainage surgery as planned surgical procedure.
  • Primary Open Angle Glaucoma or pseudoexfoliative glaucoma.
  • Black African ethnicity.

排除标准

  • Unwilling or unable to give consent or unwilling to accept randomization.
  • Inability to attend follow-up visits
  • Visual acuity of ¿no light perception¿ (NLP).
  • Previous filtering or cyclodestructive procedure in the same eye.
  • Previous ocular procedure involving the conjunctiva e.g. vitrectomy, scleral buckling, cyclodestructive procedure.
  • Previous cataract extraction (phacoemulsification, small incision cataract surgery, extra capsular cataract extraction).
  • Conjunctival scarring precluding trabeculectomy superiorly.
  • Any secondary cause of glaucoma.
  • Angle closure glaucoma.
  • Need for glaucoma surgery combined with other ocular procedures e.g cataract extraction, penetrating keratoplasty, retinal surgery.
  • Active proliferative diabetic retinopathy and/or active iris neovascularisation.
  • Pregnant or nursing women
  • Unwilling to discontinue contact lens use after surgery.
  • Chronic or recurrent uveitis.
  • Severe posterior blepharitis.

研究者

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