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临床试验/NCT03135938
NCT03135938Unknown1 期

Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
1 期
入组人数
38
试验地点
1
主要终点
Difference of DVD between two eyes

研究概览

简要总结

Purpose: To determine the surgical outcomes of the grading versus classic Inferior Oblique Anterior Transposition (IOAT) technique in treatment of patients with asymmetric dissociated vertical deviation (DVD) and inferior oblique overaction (IOOA).

Methods: In this randomized clinical trial, a total of 38 patients with IOOA of >+1 and a minimum DVD difference of 5pd between their two eyes will be included. Comprehensive ophthalmic examinations including visual acuity assessment, measurements of noncyclo- and cycloplegic refraction as well as ocular deviation, biomicroscopic and funduscopic evaluation will be performed at baseline and repeated three months after the surgery. The function of extra ocular muscles will be evaluated by duction and version movements denoting from -4 (underaction) to +4 (overaction) grades. Also, IOOA will be graded as +1 to +4 according to the covering of the cornea under the superior eyelid during the ocular movement towards supra-nasal direction. The difference of DVD≥5pd between two eyes will be considered as asymmetric DVD. All patients will be randomized in the two groups to undergo IOAT surgical procedure; in the classic group, IO muscle will be sutured to the sclera at the level of inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD between the two eyes; while in the grading group, IO muscle of the eye with more severe DVD will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference between the two eyes.

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 (Participant)

入排标准

年龄范围
7 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Overaction of inferior oblique muscle ≥+1 and asymmetric dissociated vertical deviation >5pd between their two eyes.

排除标准

  • Mental retardation
  • Nystagmus
  • Cerebral palsy
  • History of ptosis and previous surgery on any cyclovertical muscle
  • Restrictive or paralytic ocular deviations
  • Inability to maintain fixation by each eye
  • Best corrected visual acuity <20/200
  • Ocular and/or systemic anomalies
  • Follow up less than three months

结局指标

主要结局

Difference of DVD between two eyes

时间窗: three months after the surgery

alternative prism cover test

次要结局

  • Inferior oblique overaction(three months after the surgery)

研究者

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

Zahra Rabbani Khah

Ophthalmic Research center

Shahid Beheshti University of Medical Sciences

研究点 (1)

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