跳至主要内容
临床试验/NCT03062085
NCT03062085招募中不适用

Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study

Shanghai High Myopia Study Group1 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60,000
试验地点
1
主要终点
Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients

研究概览

简要总结

The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract and age-related cataract patients. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of high myopic cataract.

详细描述

High myopic cataract (HMC) has become a major high-risky type of cataract in China, which accounts for nearly 30% of cataract in recent years. Compared to age-related cataract, HMC is characterized with earlier onset, severer lens opacities, higher incidence of vitreoretinopathy and postoperative complications compared to age-related cataract(ARC).

The main purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, when compared to those age-matched ARC patients.

On the other hand, due to the lack of research in the pathogenesis of HMC, it is difficult for the investigators to precisely evaluate its risk and prognosis, and to improve its prevention and treatment. The previous study of investigators majored in a large-sample analysis on the clinical features and related genes of HMC. After preliminary screening, eight genes were selected for further investigation: 1) genes related to pathogenesis of HMC: CRYAA/ GSTP1/ TXNRD2;2) genes related to vitreoretinopathy: MCP1/ VEGFA/ CFH; 3) genes related to postoperative complications: TGFB2/ CERS2. In the present study, in order to establish a risk model of HMC from the aspect of precision medicine, the investigators are preparing to set up a comprehensive clinical database for further sequencing of selected genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale, to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of HMC.

The research aim to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, to thoroughly illustrate the influence of HMC-related genes to its prognosis and to elucidate the pathogenesis of HMC, for further promotion in the disease prevention and prognosis as well.

研究设计

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

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of cataract
  • Must be able to cooperate with the ophthalmic examination

排除标准

  • Clinical diagnosis of mental illness
  • Mentally disabled

结局指标

主要结局

Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients

时间窗: Follow-up until five years after surgery

Cataract type and severity of ametropic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.

Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients

时间窗: Follow-up until five years after surgery

Cataract type and severity of high myopic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.

Differences in the clinical phenotypes and visual outcomes of age-related cataract patients

时间窗: Follow-up until five years after surgery

Cataract type and severity of age-related cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.

次要结局

  • Genetic diversity based on biological specimen samples of three groups(Analyzed within six months after surgery)

研究者

发起方
Shanghai High Myopia Study Group
申办方类型
Other
责任方
Sponsor

研究点 (1)

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