跳至主要内容
临床试验/NCT05415553
NCT05415553招募中不适用

Inferior Oblique Muscle Belly Transposition (IOBT) Versus Inferior Oblique Muscle Recession (IO-rec) on Versions and Vertical Alignment for Primary Position Hypertropia With Inferior Oblique Overaction

Eye & ENT Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
190
试验地点
1
主要终点
Suboptimal surgical rate

研究概览

简要总结

This is a multi-center, randomized double-blind controlled trial to compare the effectiveness of IOBT with IO-Rec for the treatment of hypertropia with IOOA.

Specific Aim 1 (Primary): To study the suboptimal surgical rates between IOBT and IO-Rec for the treatment of hypertropia with IOOA.

Specific Aim 2 (Secondary): To compare the surgical successful rate of IOBT with IO-Rec for the treatment of hypertropia with IOOA.

详细描述

Using conventional surgical procedures, such as myectomy or recession of inferior oblique muscle, higher postoperative vertical overcorrection due to contralateral concealed IOOA were observed in mild primary position hypertropia with unilateral IOOA.

To achieve better outcome, IOBT was introduced. Yang et al. firstly reported that IOBT might be a useful alternative surgical treatment for patients with primary position hypertropia of less than 5△ that was associated with IOOA. Recently, our study has reported that IOBT achieved satisfactory outcomes in patients with mild primary position vertical deviation (≤10△) with unilateral IOOA, without any risk of overcorrection of vertical deviation and contralateral IOOA. Although our results are promising, there is no enough evidence to recommend IOBT for primary position hypertropia with inferior oblique overaction. A large randomized trial is needed to compare the surgical successful rate and suboptimal surgical outcomes of IOBT with IO-Rec for primary position hypertropia with inferior oblique overaction.

The proposed trial will be conducted in 9 different study sites working in the field of pediatric ophthalmology and strabismus. Each site will have one certified surgeon to do all surgeries. For IOBT, the whole belly of inferior oblique muscle is secured with a 6-0 absorbable suture, and then anchors to the sclera 5 mm behind the temporal insertion of the inferior rectus muscle. For IO-Rec, the insertion of inferior oblique muscle is excised and secured with a 6-0 absorbable suture, and then anchors to the sclera 4 mm behind and 2 mm beside the temporal insertion of the inferior rectus muscle.

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, Outcomes Assessor)

入排标准

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

入选标准

  • •Age ≥ 4 years at the time of surgery;
  • •Vertical deviation (VD) in primary position (5△ ≤ VD ≤ 10△)
  • •IOOA for three following situations:
  • •IOOA +1 for the operative eye and IOOA - for the follow eye;
  • •IOOA +2 for the operative eye and IOOA ± for the follow eye;
  • •IOOA +2 for the operative eye and IOOA +1 for the follow eye;
  • •Without amblyopia

排除标准

  • •Histories of strabismus surgery or botulinum toxin injection;
  • •Histories of intraocular surgery or refractive surgery;
  • •Restrictive or paralytic strabismus;
  • •Ocular disease other than strabismus or refractive error;
  • •Craniofacial malformations affecting the orbits;
  • •Significant neurological disorders

研究组 & 干预措施

IOBT group

Experimental

For IOBT, the whole belly of inferior oblique muscle is anchored to the sclera 5 mm behind the temporal insertion of the inferior rectus muscle.

干预措施: IOBT (Procedure)

IO-Rec group

Active Comparator

For IO-Rec, the insertion of inferior oblique muscle is excised and anchored to the sclera 4 mm behind and 2 mm beside the temporal insertion of the inferior rectus muscle.

干预措施: IO-Rec (Procedure)

结局指标

主要结局

Suboptimal surgical rate

时间窗: at 12 months

Suboptimal surgical cases/total cases. Suboptimal surgical outcomes include vertical undercorrection, vertical overcorrection and antielevation syndrome.

次要结局

  • Surgical successful rate(at 12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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