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临床试验/NCT04759560
NCT04759560Unknown不适用

Biometric Characteristics Of The Eye With Microcornea/Microphthalmia And Congenital Cataract Before And After Cataract Extraction

Alexandria University1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2020年7月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
133
试验地点
1
主要终点
Postoperative changes in the biometric characteristics of eyes at 6months

研究概览

简要总结

Early cataract surgery in microcornea/microphthalmia eyes is essential to prevent amblyopia and improve visual outcomes, including stereopsis. However, despite recent advances in pediatric cataract microsurgical techniques, this surgery remains challenging owing to several intraoperative difficulties attributable to the crowded anterior segment in these small, soft, and poorly developed eyes with shallow anterior chambers, and poor pupillary dilation.

In this study the investigator aim to report on the changes in the anterior segment biometric characteristics after cataract extraction in eyes with microcornea/microphthalmia with congenital cataract.

详细描述

Eyes with congenital cataract have usually small cornea due to developmental delay of the globe. Recognition of microcornea/microphthalmia may be important as a potential contributor to the development of aphakic glaucoma after cataract surgery. Biometrics characteristics of eyes with m/m before and after removal of the cataractous lens can justify the occurrence of postoperative complications, including glaucoma.

Aim of the study: to report on the changes in the anterior segment biometric characteristics after cataract extraction in eyes with microcornea/microphthalmia with congenital cataract.

Methods:

The study will be a prospective cohorte. Biometry of eligible eyes with congenital cataract in one or both eyes with horizontal cornea diameter less than 11mm and/or axial length less than 2standard deviation for age will be compare to otherwise normal eyes with congenital cataract before and after cataract extraction. The anterior segment biometric characteristics using ultrasound biomicroscopy to measure anterior chamber depth and angle.Cataract surgery will be conducted with or without intraocular lens implantation.Postoperative follow up will be scheduled at the first week and first month, third and sixth months

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children presenting with congenital cataract in one or both eyes and with a horizontal corneal diameter less than 11 mm and/or an axial length less than 2 standard deviations for age of the child, less than 18mm in children under one year and less than 20mm in those less than 1year (cases).
  • Children presenting with congenital cataract in one or both eyes with otherwise normal ocular biometric characteristics (controls).

排除标准

  • 1.Children presenting with congenital cataract associated with other ocular anomalies other than microcornea/microphthalmia

结局指标

主要结局

Postoperative changes in the biometric characteristics of eyes at 6months

时间窗: 6 months

the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy

Postoperative changes in the biometric characteristics of eyes at 3months

时间窗: 3 months

the anterior segment biometric characteristics will be assess using ultrasound biomicroscopy biomicroscopy

次要结局

  • Postoperative complications at 3 months(3 months)
  • Postoperative complications at 6months(6 months)

研究者

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

Nshokano Simba Gloria

Ophthalmology resident

Alexandria University

研究点 (1)

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