跳至主要内容
临床试验/NCT03342794
NCT03342794Unknown不适用

Morphologic and Biometric Characteristics of Preexisting Posterior Capsule Defects in Congenital Cataracts During the First Year of Life

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
lens thickness measured by A-scan ultrasonography

研究概览

简要总结

Few descriptive studies have focused on the anatomical parameters in patients with preexisting PCDs. The characteristics of cataract morphology and anatomical parameters in these patients remained unclear, when compared with CC patients with intact posterior capsule. We conduct the current study to compare the cataract morphology and preoperative parameters, including central corneal thickness, axial length, anterior chamber depth, lens thickness, corneal diameter, keratometry,dialated pupil diameter and intraocular pressure, between CC patients with preexisting PCDs and those with intact posterior capsule, and to explore potential risk factors for preexisting PCDs.

详细描述

This retrospective study reviewed infants (≤1 years old) with CC who were undergoing cataract extraction without IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China. CC patients with preexisting PCDs were placed in Study group, while CC patients with intact posterior capsule were included as controls.

The preexisting PCD was diagnosed if signs of a sharply bordered defect or white dots on the posterior capsule and/or in the anterior vitreous were detected. The intraoperative diagnosis of preexisting PCD was confirmed when the signs were observed after uneventful aspiration of the lens cortex. Patients who were incooperative to complete the preoperative examinations were excluded.

All CC patients were divided into two groups according to integrity of posterior capsule. Patients with a confirmed preexisting PCD were placed into the PCD group. Others with intact posterior capsule were in the control group. The preoperative data including sex, age at surgery, laterality of disease, and accompanying ocular anomalies were collected.

For all the CC patients, the preoperative examinations were completed under sedation. Central corneal thickness was obtained by a handheld ultrasonic pachymeter (PachPen, Accutome, US). Axial length, anterior chamber depth, lens thickness and length of vitreous cavity were measured via an immersion A-scan (Axis nano, Quantel Medical, French). An experienced examiner repeated the measurement 10 times and the mean value was included. The keratometry values and intraocular pressure were gained by a handheld keratometer (HandyRef-K, NIDEK, Japan) and a handheld tonometer (Icare, Vantaa, Finland), respectively. Diameter of cornea and dilated pupil (dilated by tropicamide 0.5% and phenylephrine hydrochloride 0.5%) was measured just before surgery.

All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia. Bimanual irrigation/aspiration and 2-port 23G anterior vitrectomy were performed. Three ophthalmologists reviewed all surgical recordings. The integrity of posterior capsule was masked to them. Morphological characteristics of cataracts were documented before surgery. After removing opaque cortex and/or nucleus, the configuration of preexisting PCDs was described.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • congenital cataract

排除标准

  • incooperative to complete the preoperative examinations

研究组 & 干预措施

preexisting posterior capsule defects

Other

congenital cataracts with a preexisting posterior capsule defect

干预措施: cataract surgery (Procedure)

结局指标

主要结局

lens thickness measured by A-scan ultrasonography

时间窗: 6 months

lens thickness in congenital cataracts with either preexisting posterior capsule defects or intact posterior capsule will be measured by A-scan and compared.

次要结局

未报告次要终点

研究者

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

yin ying zhao

Director

Wenzhou Medical University

研究点 (1)

Loading locations...

相似试验