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临床试验/NCT02376556
NCT02376556已完成不适用

The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Objective assessment of dry eye syndrome

研究概览

简要总结

The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.

详细描述

Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. After filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. These are all standard examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations.

The same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery.

This data will help us assess the effect of these common surgical procedures on dry eye symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
  • no other ophthalmic procedures planned for the patient in study period
  • ability to undergo full ophthalmic examination as stated in the study protocol
  • Ability to complete the dry eye questionnaire
  • ability to sign an informed consent form

排除标准

  • previous eyelid surgery
  • other orbital or lacrimal gland disease
  • concurrent use of contact lenses
  • concurrent use of Restasis
  • previous glaucoma surgery
  • use of punctual plugs
  • pregnant or nursing women

结局指标

主要结局

Objective assessment of dry eye syndrome

时间窗: 3 months postoperatively

次要结局

  • Subjective assessment of dry eye syndrome(3 months postoperatively)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Guy Ben Simon

Head, Orbital, Ophthalmic Plastic & Lacrimal Surgery department, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel

Sheba Medical Center

研究点 (1)

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