CTRI/2025/07/091771尚未招募3 期
Evaluating the Effectiveness of Botulinum Toxin Injection into the Lacrimal Gland for Managing Functional Epiphora: A Prospective Interventional Study.
Centre For Sight Eye Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年8月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of botulinum toxin injection into the lacrimal gland in reducing symptoms of functional epiphora, as measured by changes in the TEARS and MUNK scores.
研究概览
简要总结
This study employs a prospective interventional study design, enrolling eligible participants diagnosed with Functional Epiphora. Participants aged 18 and above will be given the Botulinum toxin injection and will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years and above (Both Males and Females included)
- •Patients diagnosed with Functional epiphora.
- •Presenting with excessive watering with syringing being patent
- •Patients who have given informed consent
- •Willing to complete the treatments and follow up regularly.
排除标准
- •Previous hypersensitivity to botulinum toxin or human albumin
- •Eyelid infections like blepharitis, meibomian gland dysfunction.
- •Neuromuscular junction disorders
- •Ocular motility defects
- •Active intraocular inflammation, allergy or infection.
- •Ocular surface infections and inflammations.
- •History of dry eyes
- •Eyelid structural abnormality
- •Pregnancy
- •Lactating mothers.
结局指标
主要结局
Evaluate the effectiveness of botulinum toxin injection into the lacrimal gland in reducing symptoms of functional epiphora, as measured by changes in the TEARS and MUNK scores.
时间窗: Baseline, One Month and Three Months
次要结局
- To assess patient satisfaction and subjective improvement in tearing symptoms following treatment.
研究者
Dr Divya Datta
Centre For Sight Eye Hospital
研究点 (1)
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