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临床试验/NCT05987878
NCT05987878已完成不适用

Single Minimal Conjunctival Incision for Rectus Muscles

Universidad Autonoma de Madrid1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Duration of conjunctival swelling/hemorrhage

研究概览

简要总结

The purpose of this investigation is to study the feasibility and inflammatory response of surgery for rectus muscles using a small single bulbar conjunctival incision posterior and parallel to the muscle insertion.

Patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery, will be recruited. Routinary clinical ophthalmological examination will be carried out. After applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main outcome measure will be duration of swelling and hemorrhage, and secondary outcome measure will be motor outcome at 2 months after surgery.

详细描述

Purpose/Background: To study the feasibility and inflammatory response of surgery for rectus muscles using a small single bulbar conjunctival incision posterior and parallel to the muscle insertion.

Methods: Patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery, are included. Routinary clinical ophthalmological examination is carried out. After applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main outcome measure is duration of swelling and hemorrhage, and secondary outcome measure is motor outcome at 2 months after surgery. Results are compared with retrospectively collected data of patients operated using limbal (n= 20) and fornix incision (n= 21) as a point of reference.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia

排除标准

  • patients had no previous eye muscle surgery

结局指标

主要结局

Duration of conjunctival swelling/hemorrhage

时间窗: 2 months

Evaluate duration of conjunctival swelling/hemorrhage

次要结局

  • Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)(2 months)

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 (1)

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