CTRI/2024/04/066108尚未招募不适用
A comparative study to evaluate the efficacy of intracameral fixed drug combination of mydriaticand anaesthetic in comparison with topical mydriatic for phacoemulsification in immature cataracts
Bangalore medical college and research Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mydriasis
研究概览
简要总结
-
To evaluate the efficacy of intracameral fixed drug combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% in comparison with topical tropicamide 0.8% and phenylephrine 5% in terms of pupil dilatation.
-
To evaluate the efficacy of intracameral fixed drug combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% in comparison with topical tropicamide 0.8% and phenylephrine 5% in terms of patient comfort.
-
To evaluate the safety of intracameral fixed drug combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with senile immature cataract.
- •Patients willing to give informed consent for the study.
- •Patients who are to be taken up for phacoemulsification cataract surgery.
- •Patients with adequate preoperative pupillary dilatation.
排除标准
- •Patient not willing to give consent for the study.
- •Cataracts other than senile immature cataracts.
- •concurrent ocular pathologies.
- •Patients using drugs that affect the pupillary diameter.
- •Gross corneal opacities that affect the visibility of pupil on slit lamp.
- •Patients known to be sensitive to all the study drugs.
- •Patients with involuntary eye movements.
结局指标
主要结局
Mydriasis
时间窗: before and after the administration of mydriatics in each group.
次要结局
- pain felt intraoperatively(Immediate post operatively)
研究者
研究点 (1)
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