NCT00595855已完成不适用
Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
研究概览
简要总结
Patients affected by medically uncontrolled open angle glaucoma will be randomised to either a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and co-morbidities) will be evaluated.
详细描述
Prospective 7-year randomised investigator -masked clinical trial 79 eyes (79 patients) enrolled randomised to surgery by PEX and previous pilocarpine use Deep sclerectomy n = 41 Trabeculectomy n = 38 Estimated DS : TE success = 1:3 10% attrition ; power = 90%, alpha = 5%
Methods and evaluation of outcomes:
- IOP: average of the two highest readings of the IOP phasing (6 readings)
- VA: LogMAR (ETDRS chart)
- Lens: LOCSII (slit lamp classification), worsening = one step progression confirmed at two visits
study visits: every 4 months
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angle wide open
- •Age > 65 yrs
- •IOP > 23 and < 30 mmHg (average of the two highest readings of the daily IOP phasing)
- •Topical beta blocker in fellow eye
- •At least two medications in use + previous ALT
- •MD < 20 dB (HFA 24-2 full threshold)
- •LOCSII < C1-N1-P0
排除标准
- 未提供
结局指标
主要结局
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
时间窗: 7 years
次要结局
- (a) LogMAR visual acuity, (b) number of cataract extraction procedures(7 years)
研究者
研究点 (2)
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