Comparative Study Between Frontalis Flap Advancement Versus Frontalis Sling Operations in Mangment of Congenital Blepharoptosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement of MRD ( marginal reflex distance )
研究概览
简要总结
A prospective comparative study between the results obtained by applying frontalis muscle flap advancement and frontalis sling operations for correction of congenital ptosis with poor levator muscle function. Study will include evaluation of the functional and cosmetic results, recurrence rates, and the incidence and varieties of different complications between the two techniques
详细描述
-
Population of study & disease condition: Congenital ptosis with poor levator muscle function.
-
Study setting: The ophthalmology unit of Abuelreesh Children Hospital.
-
Inclusion criteria:
Criteria for inclusion in this study will be children more than 1 years age with:
- moderate to severe ptosis with margin reflex distance1 (MRD1) ≤2 mm,
- poor levator function of <4 mm,
- good frontalis muscle function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cases of congenital ptosis
排除标准
- •associated with other anomalies e.g: blepharophimosis syndrome , marcus gunn jaw winking.
- •previous ptosis surgery.
结局指标
主要结局
Improvement of MRD ( marginal reflex distance )
时间窗: About 6 months
Improvement of the marginal reflex distance that is measured by the ruler, which is the distance between the margin of the upper eyelid and the light reflex reflecting from the cornea from a torch against the cornea
次要结局
- Improvement of the vertical palpebral fissure height(6 months)
研究者
Hesham Ibrahim Abd ElFattah Ibrahim Shahin
Principal investigator
Cairo University