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临床试验/NCT05980962
NCT05980962已完成不适用

Anteriorization of the Inferior Oblique Muscle Versus Anteriorization and Resection for Asymmetrical Dissociated Vertical Deviation With Inferior Oblique Muscle Overaction

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
reduction of the magnitude of DVD

研究概览

简要总结

The goal of this clinical trial is to compare the results of two surgical modalities in patients with Dissociated vertical deviation with inferior oblique muscle overaction . The main questions it aims to answer are:

  • How much does the magnitude of DVD improve after each modality?
  • Is the IOOA eliminated? Participants will be divided into two equal groups; Researchers will compare the efficacy of symmetrical anteriorization of the inferior oblique and adding an additional rescetion to one eye in the second group to see which group had more signifcant reduction in the magnitude of DVD and IOOA.

详细描述

A prospective study was performed on patients with bilateral symmterical dissociated vertical deviation(DVD) and bilateral inferior oblique muscle overaction (IOOA) in Cairo University hospitals starting from February 2018 through December 2021. Patients wetre included in the study if they had a minimum follow up period of 6 months. The study included 54 patients (108 eyes) with manifest DVD and IOOA in boths eyes. Patients were divided into two equal groups. The paitents in group 1 underwent symmetrical inferior oblique muscle anteriorization, while the patients in group 2 underwent ayymmetrical surgery , where inferior oblique anteriorization was performed in one eye the same manner is in group 1, and the eye with the larger deviation had an additional 3-5 mm rescetion of the inferior oblique muscle along with anteriorization according to the measured DVD difference between both eyes, whether less than or more than 5 prism diopters respectively.

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
Double (Participant, Care Provider)

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Manifest DVD decompensated to a tropia with free ocular motility
  • Cases with or without horizontal misalignment
  • Cases with or without previous horizontal muscle surgery

排除标准

  • Incomitant, Paralytic or restrictive strabismus
  • Eyes with previous inferior oblique muscle surgery
  • Recurrent DVD after surgical treatment
  • Eyes with previous scleral buckling for retinal deatchment

结局指标

主要结局

reduction of the magnitude of DVD

时间窗: 1 week ,1 month, three months, six months

degree of reduction of the deviation measured in prism diopters

次要结局

  • reduction of magnitude of IOOA(1 week ,1 month, three months, six months)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Osama Mohamed

Dr.

Kasr El Aini Hospital

研究点 (2)

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