Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status
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
- 是
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
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
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
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
Maya Eiger
Medical Doctor
Rabin Medical Center
