NCT02049333已完成不适用
Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study
Credit Valley EyeCare4 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Anterior Chamber Angle Depth (nasal angle)
研究概览
简要总结
The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has to be ≥ 18 years of age of either gender
- •Nuclear sclerotic cataract graded by LOCS III to be < 5
- •Diagnosis of Plateau Iris Configuration or Syndrome
- •No contraindication for cataract or ECPL operation
- •Written informed consent on IRB approved Informed Consent Form
排除标准
- •Hard cataracts, LOCS III 5 and 6
- •Ciliary body cysts
- •Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.)
- •Congenital anomaly of the irido-trabecular angle
- •Previous intraocular surgery
- •Previous laser gonioplasty to either eye
- •Placement of the intraocular lens in any place other than the capsular bag
- •Pupilloplasty
- •Peripheral anterior synechiae (PAS) nasal angle and/or >180 degrees of PAS
- •Neovascular glaucoma; or glaucoma associated with vascular ischemic disorders
- •Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
- •Corneal opacities or disorders that would inhibit visualization of the nasal angle
- •Chronic ocular inflammatory disease or presence of active ocular inflammation with risk for synechial/proliferative changes
- •Inability to attend regular follow-up assessment or to give informed written consent.
结局指标
主要结局
Anterior Chamber Angle Depth (nasal angle)
时间窗: Twelve months
Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging
次要结局
- Number of glaucoma medications(Twelve months post-op)
- Intraocular pressure (IOP)(Twelve months post-op)
研究者
Iqbal Ike Ahmed
MD
Credit Valley EyeCare
研究点 (4)
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