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临床试验/NCT03555045
NCT03555045Unknown2 期

The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
100
试验地点
1
主要终点
far-near deviation difference

研究概览

简要总结

Different methods was tried to treat high AC/A strabismus cases;such as prescription of bifocal glasses in esotropia,recession of horizontal muscles with posterior fixation sutures,more recession than needed for far deviation(augmented recession),recession and pulley fixation and slant recession.

Different results was reported for any type of above methods. In recent studies,slanted recession was applied for high AC/A in esotropic cases and success rate of 67% was reported.but there was no unanimity for procedure of choice.

Since slant recession method is simpler and has low side effect than the other methods,therefore in this study the investigators want to peruse the outcome of this method on high AC/A horizontal strabismus.

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
6 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients with horizontal strabismus that the different between far deviation and near deviation is more than 10 pd

排除标准

  • all patients who had history of surgery on horizontal muscles and patients with pseudo high AC/A ratio.

研究组 & 干预措施

conducting the slanted recession technique

Active Comparator

conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.

干预措施: conducting the slanted recession technique on the superior and inferior poles (Procedure)

conducting the augmented recession technique on the muscle

Active Comparator

conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.

干预措施: conducting the augmented recession technique on the muscle (Procedure)

结局指标

主要结局

far-near deviation difference

时间窗: 90 days after surgery

difference between the far and near deviations

次要结局

  • success rate of surgery(90 days after surgery)

研究者

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

Zahra Rabbani Khah

Clinical Professor

Shahid Beheshti University of Medical Sciences

研究点 (1)

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