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临床试验/NCT02638610
NCT02638610Unknown不适用

Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries

Meir Medical Center0 个研究点目标入组 60 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters).

研究概览

简要总结

The aim of the study: Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries.

Study design: an interventional study that will be conducted at the ophthalmology department, Meir hospital, Kfar Saba, Israel.

the study will include 60 healthy patients, at the ages of 40-80, which are candidates for eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion repair.

The patients will be recruited from Meir's ophthalmology outpatient clinic. Each patient will undergo a full ophthalmologic examination including relevant assessment of the specific eyelid pathology.

The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet filament-type aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to give consent
  • Eyelid pathology: blepharoptosis, blepharochalasis, ectropion or entropion, with no additional eyelid pathology

排除标准

  • Children and pregnant women
  • Previous eyelid surgery
  • A systemic disease influencing eyelid position
  • Any neurologic disease
  • Previous facial herpetic infection

结局指标

主要结局

Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters).

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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