跳至主要内容
临床试验/NCT05778565
NCT05778565进行中(未招募)不适用

Stretching of an Extraocular Rectus Muscle as a Weakening Procedure

Universidad Autonoma de Madrid2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
7
试验地点
2
主要终点
Distance deviation at 2 months after surgery

研究概览

简要总结

Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. One double needle 6/0 Mersilene suture is used on each side of the muscle at 4 mm distance of the insertion and pulled / stretched to insert in the sclera 3-5 mm posterior to the muscle locking passes.

Seven patients with esotropia of 12-20 PD were included.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring weakening of medial rectus muscle(s) for 12-20 PD of esotropia who could cooperate with topical / sub-Tenon's anesthesia, and had no previous eye muscle surgery

排除标准

  • Patients with previous strabismus surgery

结局指标

主要结局

Distance deviation at 2 months after surgery

时间窗: 2 months

Distance deviation at 2 months after surgery (alternate prim and cover)

次要结局

未报告次要终点

研究者

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

Jaime Tejedor

Principal Investigator

Universidad Autonoma de Madrid

研究点 (2)

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