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临床试验/NCT01282541
NCT01282541已完成2 期

Determination of the Optimum Delivery Route for the Intraglandular Administration of Botulinum Toxin A in Patients With Refractory Epiphora

Merbs, Shannath, M.D., Ph.D.1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up

研究概览

简要总结

Epiphora or excessive tearing is a significant disability for many affected patients diminishing their quality of life. There is a growing consensus that injection of Botulinum Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help to reduce normal tear production in patients with epiphora from anatomic or functional outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes have been successful in symptom relief with minimal complications. However, the effectiveness of transconjunctival versus transcutaneous injections has not been systematically compared. Also, whether the incidence of side effects is related to the dosage, concentration, or location of injection is unknown and has also not been systematically studied. The investigators plan to conduct a randomized clinical trial in patients with functional tearing comparing the transcutaneous delivery route of BTX-A to the transconjunctival delivery route (the most common route described in the literature). The investigators will also compare the side effect profile of each delivery route.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years
  • ability to give informed consent
  • symptoms of epiphora in the setting of either a patent lacrimal outflow system or an obstructed outflow system for which the patient does not desire surgical therapy or is a poor surgical candidate

排除标准

  • pregnancy
  • ocular motility abnormalities
  • prior ptosis, and/or strabismus surgery
  • more than 2 mm of pre-existing ptosis
  • inability to give informed consent
  • history of a bleeding disorder

研究组 & 干预措施

Transconjunctival

Active Comparator

干预措施: Botulinum Toxin Type A (Drug)

Transcutaneous

Active Comparator

干预措施: Botulinum Toxin Type A (Drug)

结局指标

主要结局

Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up

时间窗: 24 weeks

次要结局

  • Comparison of side effect between each treatment group(24 weeks)
  • Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up(24 weeks)

研究者

发起方
Merbs, Shannath, M.D., Ph.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Shannath Merbs, M.D., Ph.D.

Associate Professor of Ophthalmology and Oncology

Merbs, Shannath, M.D., Ph.D.

研究点 (1)

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