跳至主要内容
临床试验/NCT03392272
NCT03392272Unknown不适用

Modified Müller's Muscle-conjunctival Resection Internal Ptosis Repair Using Fibrin Glue

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Pain level

研究概览

简要总结

Fibrin glue is widely used in ophthalmology for homeostasis and tissue recovery. It is commonly used in ocular surface surgeries such as pterygium removal and conjunctival lesions excisions. In Müller's muscle-conjunctival resection (MMCR), sutures are used to reconnect the conjunctiva and Muller muscle, which causes discomfort and pain for the patient. The investigators' goal is to explore using fibrin glue instead of sutures in MMCR surgeries to shorten the procedure's length and alleviate patients discomfort and pain. This is especially important in the management of children suffering ptosis, where sedation and even general anaesthesia is required for sutured removal as a secondary procedure.

详细描述

Fibrin glue is widely used in ophthalmology for homeostasis and tissue recovery. It is commonly used in ocular surface surgeries such as pterygium removal and conjunctival lesions excisions.

Müller's muscle-conjunctival resection (MMCR) is the most common surgery for ptosis correction and is normally performed under local anaesthesia. In MMCR, a portion of the Muller and conjunctiva is resected, and sutures are used to reconnect the remaining edges. The suturing process requires several minutes and causes discomfort to the patient. In addition, many patients experience post operative discomfort due to the touch of the sutures in the superior ocular surface until their removal about 7-14 days post op. Moreover, the sutures removal process is commonly unpleasant, and in the pediatric patients requires sedation or general anaesthesia.

The investigators' goal is to explore using fibrin glue instead of sutures in MMCR surgeries to shorten the procedure's length and alleviate patients discomfort and pain. This is especially important in the management of children suffering ptosis, where sedation and even general anaesthesia is required for sutured removal as a secondary procedure.

Methods:

A prospective randomized study. Patients will be randomized into traditional MMCR using sutures, vs. MMCR using tisseel glue. Follow up will take place 1 day, 7 days, 1 month and 3 months post op. Main outcome measures included patient reported outcome such as pain grade and discomfort, and success of ptosis repair surgery defined by improvement in margin reflex distance, symmetry of upper eyelid position, and incidence of complications.

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 (Care Provider)

盲法说明

The physician will randomly assign the patient into the tisseel group or the sutures group

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ptosis referred to Müller's Muscle-Conjunctival Resection (MMCR)

排除标准

  • Previous eyelid surgery

研究组 & 干预措施

Tisseel

Experimental

Müller's Muscle-Conjunctival Resection (MMCR) using glue instead of sutures

干预措施: Using of Tisseel fibrin glue (Device)

Sutures

Active Comparator

Müller's Muscle-Conjunctival Resection (MMCR) using the usual procedure

干预措施: Using sutures (Other)

结局指标

主要结局

Pain level

时间窗: until 2 weeks post op

Pain grade using visual analogue scale of 0-10 with 0=no pain and 10=worst pain.

次要结局

  • successful ptosis correction(3 months)

研究者

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

Dr. Guy Ben-Simon, MD

Head, oculoplastic unit

Sheba Medical Center

研究点 (2)

Loading locations...

相似试验