NCT00801359已完成2 期
Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- endothelial cell density
研究概览
简要总结
Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this prospective, randomized, masked trial to investigate for differences in preservation of corneal integrity after phacoemulsification cataract surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with senile cataract
- •Visual acuity between 20/400 and 20/40
排除标准
- •Presence of corneal opacity
- •Presence of corneal disease
- •Traumatic, toxic, hereditary (congenital)and complicated cataracts(uveitis)
- •Anterior chamber cells or flare detected before surgery
- •Previous ocular surgery
- •Any condition which may affect documentation or follow-up
研究组 & 干预措施
BSSplus
Active Comparator
干预措施: Phacoemulsification (Procedure)
BSSplus
Active Comparator
干预措施: BSSPlus solution (Drug)
Ringer
Experimental
干预措施: Phacoemulsification (Procedure)
Ringer
Experimental
干预措施: Lactated Ringer's solution (Drug)
结局指标
主要结局
endothelial cell density
时间窗: baseline and at 1, 8, 15, 30 and 60 days postoperatively
central corneal thickness
时间窗: baseline and at 1, 8, 15, 30 and 60 days postoperatively
次要结局
- number of anterior chamber cells and flare grade(baseline and at 1, 8, 15, 30 and 60 days postoperatively)
研究者
研究点 (1)
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