The Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure Height, Ocular Surface and Tearing
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Palpebral Fissure Height
研究概览
简要总结
The purpose of this research study is to test if Topical (applied to the surface of the eye) Botulinum Toxin temporarily lowers the upper eyelid and makes the eyelid appear less open and thereby affects the eye surface and decreases reflexive tearing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and above that present to the oculoplastic and reconstructive surgery department that are able to provide informed consent to participate
- •Presence of upper eyelid retraction or asymmetry( >1mm)
排除标准
- •Adults unable to consent
- •Individuals less than 18 years of age
- •Prisoners
- •Pregnant women. o Patients will be asked if they are pregnant by research staff before participation in the study.
- •Women who are breast-feeding
- •Known contradictions or sensitivities to study medication
- •Grossly abnormal lid margins, anatomical abnormalities
- •Variable ptosis or eyelid position (e.g., myasthenia gravis, blepharospasm)
- •Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
- •Presence of an active ocular infection
- •Inability to sit comfortably for 15 - 30 minutes
- •Botulinum toxin injection in the eyelids during the past 3 weeks.
- •Neuromuscular disorders (e.g., Parkinson's disease or myasthenia gravis)
- •Medication use known to interfere with the effects of botulinum toxin-A within the previous 1 month (e.g., aminoglycoside or benzodiazepines),
- •Previous history of hypersensitivity reactions to botulinum toxin-A
- •Dysfunction of tear production or secretion (e.g., meibomian gland dysfunction or Sjogren's syndrome),
研究组 & 干预措施
Botulinum toxin group
The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes.
干预措施: Botulinum toxin (Drug)
结局指标
主要结局
Change in Palpebral Fissure Height
时间窗: baseline and Day 3
Palpebral fissure on Day 3 minus palpebral fissure at baseline. Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin.
次要结局
- Corneal Staining Density(Day 3)
- Change in Tearing(baseline and Day 3)
研究者
Wendy Lee
Professor of Clinical
University of Miami