Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 主要终点
- Occurrence of new self-reported general eye or dysphotopsia symptoms
研究概览
简要总结
The purpose of this study is to determine if location of laser peripheral iridotomy (LPI) that is the standard of care treatment for angle closure glaucoma is related to changes in post-operative intraocular pressure (IOP), endothelial cell count,anterior chamber angle morphology and onset of new visual disturbances.
详细描述
Study hypothesis: Location of laser peripheral iridotomy affects occurrence of post-operative dysphotopsia symptoms, intraocular pressure, anterior chamber angle morphology and corneal endothelial cell count Study design: Multicenter randomized, prospective, single masked trial Trial setting: Hospitals Trial type: Treatment
Interventions: South Indian subjects aged 30 years or greater, with primary angle closure suspect (PACS) or primary angle closure/ primary angle closure glaucoma(PAC/PACG) will be randomized to either bilateral superior or nasal/temporal laser peripheral iridotomy. Subjects will undergo noninvasive testing and imaging studies to measure IOP, anterior chamber angle morphology and endothelial cell count and asked to answer a questionnaire at baseline and again at 2 weeks and 6 months after treatment Primary outcome measures: Occurrence of new self-reported general eye or dysphotopsia symptoms.
Secondary outcome measures: intraocular pressure, anterior chamber and anterior chamber angle morphology, endothelial cell count.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of PACS or PAC/PACG in at least one eye
排除标准
- •bilaterally pseudophakic
- •prior iridotomy, iridoplasty, or incisional glaucoma surgery in either eye
- •signs or symptoms consistent with acute angle closure at time of enrollment
结局指标
主要结局
Occurrence of new self-reported general eye or dysphotopsia symptoms
时间窗: 6 Months
Questionnaire using a Likert scale
次要结局
- Anterior chamber angle morphology(6 Months)
- Choroidal thickness(6 Months)
- Intraocular pressure(6 Months)
- Corneal endothelial cell count(6 Months)
研究者
Venkatesh Rengaraj
Clinical Research Coordinator
Aravind Eye Care System