Prophylactic Laser Iridotomy for Eyes With Narrow Drainage Angles; A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 544
- 试验地点
- 2
- 主要终点
- Peripheral anterior synechiae formation
研究概览
简要总结
This is a multicentric, randomised, controlled study comparing Laser Iridotomy (LI) to no treatment in subjects with asymptomatic narrow angles (ANA).One eye of each subject with ANA will be randomised to undergo LI and the other eye will be left alone and will serve as an internal control. Subjects are proposed to be followed up once a year for 5 years.
详细描述
Objective
This study will compare LI versus no treatment in subjects with asymptomatic narrow angles, the anatomical trait that predisposes to primary angle closure glaucoma (PACG), in order to assess the effectiveness of prophylactic treatment in the prevention of blindness due to PACG.
Eligibility: 1. Bilateral Narrow angles; 2. Age 50 years and above; 3. Informed consent obtained prior to or at baseline visit.
Trial Design: Subjects with asymptomatic ANA undergoes randomisation after comprehensive ocular exam followed by randomisation to LI in one eye and no treatment in the other eye. Follow up is done for 5 years with yearly examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral Narrow angles
- •Age 50 years and above
- •Informed consent obtained prior to or at baseline visit
排除标准
- •Presence of PAS
- •IOP > 21 mm Hg
- •Glaucomatous optic neuropathy and/or CDR > 0.7
- •Secondary angle closure such as uveitis, neovascularisation etc.
- •Prior intraocular surgery or penetrating eye injury
- •Corneal disorders such as corneal endothelial dystrophy except mild corneal guttae
- •Evidence of prior acute angle closure event
- •High risk of acute angle closure.
- •Significant cataract and visual acuity less than 20/40
- •Constant use of contact lens for refractive correction
- •Chronic use of topical or systemic steroids
- •Established retinopathies on ocular treatments (e.g. Diabetic)
- •Any other disease which is likely to cause field loss in next 3 years
- •Severe health problems decreasing life expectancy to less than one year.
结局指标
主要结局
Peripheral anterior synechiae formation
IOP elevation >21 mm Hg
Development of acute angle closure event
次要结局
- Changes in the grading of Modified Schaffer Grading
- Development of glaucomatous optic neuropathy
- Development of corresponding visual field loss by automated perimetry
- Change in HRT optic disc parameters
- Change in UBM angle parameters
- Formation of disc pallor