跳至主要内容
临床试验/NCT02626416
NCT02626416Unknown不适用

Self-monitoring of Visual Axis Opacification (VAO) Under Non-clinical Settings in China

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,400
试验地点
1
主要终点
Times of follow-ups for each participant

研究概览

简要总结

The incidence rate of postoperative capsular opacification (PCO) in children after cataract surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term follow-up, timely diagnosis and treatment is important to improve patient's outcome.

The major and central part of lens is easy to be observed through a dilated pupil. Especially, opacification in the lens and/or lens capsule is distinctive showing as "white" on the "black" background. The characteristic features of the disease and advances in photographic technique with mobile phone make it possible for patients and/or their guardians to monitor the progress of cataract or PCO with mobile application in a "self-help" manner under non-clinical settings.

详细描述

The incidence rate of postoperative capsular opacification (PCO) in children after cataract surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term follow-up, timely diagnosis and treatment is important to improve patient's outcome.

The major and central part of lens is easy to be observed through a dilated pupil. Especially, opacification in the lens and/or lens capsule is distinctive showing as "white" on the "black" background. The characteristic features of the disease and advances in photographic technique with mobile phone make it possible for patients and/or their guardians to monitor the progress of cataract or PCO with mobile application in a "self-help" manner under non-clinical settings. In this way, patients and/or guardians could adjust the time of return to clinical follow-up visit accordingly. Furthermore, standardized and analyzed pictures could be sent to clinicians for remote diagnosis when necessary.

The investigators developed a mobile phone application LenZOC. The investigators aimed to assess whether mobile phone application for parents of children with cataracts would improve their adherence with follow-up and increase rates of timely detection and management of treatable conditions such as posterior capsular opacification (PCO).

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

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Children after cataract surgery for more than 1 year without any postoperative complications
  • •Without other ocular abnormality
  • •Parents owned a smart mobile phone that meets the requirements for installation of the LenZOC
  • •Written informed consents provided

排除标准

  • •Intraocular pressure >21 mmHg
  • •Pre-existing ocular diseases including but not restricted to:
  • •Glucoma Micro-cornea Micro-ophthalmic Diseases of post-segment that might lead to VAO

研究组 & 干预措施

telemedicine group

Experimental

Congenital cataract patients use telemedicine to pursue and adjust the time of follow-up under non-clinical settings

干预措施: LenZOC (mobile application) (Device)

non-telemedicine group

No Intervention

Congenital cataract patients pursue and adjust the time of follow-up through outpatient visit in the hospital

结局指标

主要结局

Times of follow-ups for each participant

时间窗: up to one year

次要结局

  • Best corrected visual acuity(up to 24 weeks)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

Loading locations...

相似试验

Monitoring of Visual Axis Opacification Under... | 临床试验