Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- MRD1
研究概览
简要总结
Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.
In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:
- anterior approach - skin incision and levator muscle insertion advancement.
- posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results.
in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.
详细描述
Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.
In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:
- anterior approach - skin incision and levator muscle insertion advancement.
- posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results.
in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Involutional ptosis
- •No previous eyelid surgery
排除标准
- •Previous eyelid surgery or trauma
- •Congenital ptosis
- •Previous glaucoma filtrartion surgery
- •Unwillingness for six months followup
结局指标
主要结局
MRD1
时间窗: 6 months
Distance in millimeters between corneal light reflex and upper eyelid margin
Levator function
时间窗: 6 months
change (in millimeters) in upper eyelid position from downgaze to maximal upgaze
surgery duration
时间窗: 3 hours
Time from first incision to last suture (in minutes)
次要结局
- Need for additional eyelid surgery(6 months)
- Eyelid or ocular secondary disease(6 months)
研究者
Arie Nemet
Professor
Meir Medical Center