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临床试验/NCT05947331
NCT05947331进行中(未招募)不适用

Graded Anderson Versus Kestenbaum Procedure for Correction of Head Turn in Idiopathic Infantile Nystagmus

Zagazig University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年4月5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
28
试验地点
2
主要终点
Degree of head turn

研究概览

简要总结

Infantile nystagmus is involuntary, bilateral, conjugate and rhythmic oscillations of the eyes which may present at birth or develop within the first 6 months of life. It may be idiopathic appearing without visual or neurological impairment or may be secondary to an afferent visual defect such as foveal hypoplasia, congenital cataract, retinal dystrophy or optic atrophy. Aiming at improving outcome of head turn in idiopathic infantile nystagmus, comparison between the efficacy and safety of graded Anderson procedure and Kestenbaum procedure is essential.

详细描述

Infantile nystagmus related abnormal head position is noted according to the axis, it can be anomalous horizontally (right or left head turn), vertically (chin up or down), torsionally (right or left head tilt) or in a mixed pattern. A head turn to right or left is the most common compensatory posture encountered in patients with infantile nystagmus with an eccentric null position. A prolonged head turn (HT) may interfere with the social interactions and the quality of life and may lead to skeletal deformities in the cervical spine with postural dysfunction and impaired movement pattern. Thus, the correction of an abnormal head turn is important to enlarge the visual field, to eliminate the possibility of abnormal contracture of the neck muscles and to permit an adequate vision.Various extraocular muscle surgeries have been advised to correct infantile nystagmus-related HT. Despite being the most common surgical technique used till today for correction of head turn related to nystagmus, Kestenbaum procedure has variable long- term results, limited success rate and involves four rectus muscles (recession/ resection). In graded Anderson procedure, only yoke muscle recession is done based on the amount of initial head turn leaving two untouched muscles.

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
5 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Orthophoric Patients with idiopathic infantile nystagmus related head turn (≥20 degrees - ≤ 45 degrees) that is verified at least twice in two separate visits.

排除标准

  • Patients with infantile nystagmus secondary to ocular diseases
  • Patients with infantile nystagmus with associated strabismus.
  • Previous squint, scleral buckling or glaucoma surgeries.
  • Associated systemic or neurological disorders.
  • Patients with anisometropia ≥ 5D.
  • Patients with nystagmus attenuated at near

结局指标

主要结局

Degree of head turn

时间窗: Base line and 6 months postoperatively.

assess the change from Baseline degree of head turn at 6 months postoperatively using protractor goniometer

次要结局

  • Best corrected visual Acuity(Base line and 6 months postoperatively)
  • stereopsis(Base line and 6 months postoperatively.)
  • complications(6 months postoperatively)

研究者

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

Sara Fawzy Ibrahim Mahmoud Eid

Assisstant lecturer of ophthalmology

Zagazig University

研究点 (2)

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