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临床试验/CTRI/2024/03/064786
CTRI/2024/03/064786尚未招募不适用

A Prospective study of Myopia Progression in Children following surgical intervention for Intermittent exotropia

Purva Kavishwar1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Rate of myopia progression in patients who underwent surgical intervention for intermittent exotropia

研究概览

简要总结

The purpose of this study is to prospectively study myopia progression in children who underwent surgical intervention for intermittent exotropia. Role of myopia in intermittent exotropia is reportedly due to increased accommodative demand caused by the exodeviation. The patients aged 5-15 years who fulfil the inclusion/exclusion criteria will be enrolled for the study and thoroughly counselled. At 2 weeks post- operatively, A scan biometry will be done for every patient to measure the axial length. A questionnaire will be handed over to the parents which includes questions related to risk factors associated with myopia progression. Patients will be followed up on 6 months and 12 months and they will undergo visual acuity testing, cycloplegic refraction with 3m Snellen’s chart, intraocular pressure measurement, anterior and posterior segment evaluation and A scan biometry to measure axial length (LENSTAR). Myopia progression will be analyzed and documented in terms of spherical equivalent and axial length.

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients who underwent surgery for IXT and achieved correction within plus/minus 10 prism diopters at 2 weeks post operatively.
  • 2.Patients with myopia minus 0.5D to minus 6D 3.Astigmatism less than 2D 4.Anisometropia less than 2D 5.Amblyopia with BCVA more than 6/12.

排除标准

  • 1.Patients with high myopia more than minus 6D 2.Lenticular myopia 3.K reading less than 36D or more than 48D 4.Previous ocular surgeries 5.Previous treatment with atropine or myopia control spectacle lenses or ortho K contact lenses 6.Retinopathy of prematurity/ congenital anomaly / glaucoma/retinal pathology.

结局指标

主要结局

Rate of myopia progression in patients who underwent surgical intervention for intermittent exotropia

时间窗: At baseline, 6 months, 12 months

次要结局

  • To analyze whether age of surgery for intermittent exotropia influences myopia progression(18 months)

研究者

发起方
Purva Kavishwar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Purva Kavishwar

Aravind Eye Hospital, Chennai

研究点 (1)

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