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临床试验/NCT04803097
NCT04803097已完成不适用

Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens

Yune Zhao1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
PCOA

研究概览

简要总结

Lens capsular often changes after pediatric cataract surgery,causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.

详细描述

To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.

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
6 Months 至 96 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children (age 0.5~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.

排除标准

  • Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.

结局指标

主要结局

PCOA

时间窗: 20.74 ± 7.89 months

A comparison of posterior capsular opening areas at the corresponding time points

VATA

时间窗: 20.74 ± 7.89 months

A comparison of visual axis transparent areas at the corresponding time points

次要结局

  • axial length growth(20.74 ± 7.89 months)

研究者

发起方
Yune Zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

研究点 (1)

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