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临床试验/NCT02501187
NCT02501187Unknown不适用

Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
75
试验地点
1
主要终点
Diagnosis of objective or subjective deterioration in dry eye status

研究概览

简要总结

Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.

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
Single (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

  • Ptosis which indicate surgical repair
  • The ptosis must be suitable for repair in any of the procedures

排除标准

  • Systemic disease which may cause ocular surface disease (eg Sjogren disease)
  • Previous orbital or eyelid surgery
  • Significantly dry eyes

研究组 & 干预措施

Patients operated for ptosis by levator advancement

Experimental

patients undergoing surgical repair for aponeurotic ptosis by the procedure- levator advancement.

干预措施: Levator advancement (Procedure)

Patients operated for ptosis by white line advancement

Experimental

patients undergoing surgical repair for aponeurotic ptosis by the procedure- white line advancement

干预措施: White line advancement (Procedure)

Patients operated for ptosis by Müller resection

Experimental

patients undergoing surgical repair for aponeurotic ptosis by the procedure- Müller's muscle-conjunctival resection.

干预措施: Müller's muscle-conjunctival resection procedure (Procedure)

结局指标

主要结局

Diagnosis of objective or subjective deterioration in dry eye status

时间窗: 6 months

Dry eye status will be measured by a composite of tests, including Ocular surface disease index (OSDI) questionnaire (which indicates subjective status), and a number of objective tests - Shirmer test, Flurocein dye, Lissamine green dye and tear breakup time

次要结局

  • Ptosis repair procedure success(6 months)

研究者

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

Maya Eiger

Medical Doctor

Rabin Medical Center

研究点 (1)

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