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临床试验/NCT06298929
NCT06298929招募中不适用

Medial Rectus Muscle Fenestration Versus Medial Rectus Recession for Partially Accommodative Esotropia

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月15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
60
试验地点
1
主要终点
Ocular alignment (measured in prism diopters)

研究概览

简要总结

This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.

All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration.

详细描述

Inclusion criteria The study will include patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.

Exclusion criteria:

  1. Patients with convergence excess esotropia, defined as a near deviation with glasses exceeding that for distance by 15 PD or more.
  2. Patients with paralytic or restrictive strabismus.
  3. Patients with previous strabismus surgery
  4. Patients with neurologic, ocular, or developmental disorders or follow-up less than 6 months

All patients will receive complete ophthalmic and orthoptic assessment including:

i) A full ophthalmological assessment including history taking, measurement of uncorrected and best-corrected visual acuity, cycloplegic refraction, anterior segment examination, as well as a dilated fundus examination.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.

排除标准

  • convergence excess esotropia.
  • paralytic or restrictive strabismus.
  • previous strabismus surgery
  • neurologic, ocular, or developmental disorders or follow-up less than 6 months

研究组 & 干预措施

Group 1

Active Comparator

patients with PAET who will receive unilateral or bilateral MR fenestration

干预措施: medial rectus fenestration (Procedure)

Group 2

Active Comparator

patients with PAET who will receive unilateral or bilateral MR recession

干预措施: medial rectus recession (Procedure)

结局指标

主要结局

Ocular alignment (measured in prism diopters)

时间窗: 6 months postoperative

The distance and near angles of deviation, with and without glasses, and the angle disparity

次要结局

  • ocular motility(6 months postoperative)

研究者

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

Ameera Gamal Abdelhameed

assistant professor of ophthalmology

Mansoura University

研究点 (1)

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