Clinical Trial: Shanghai High Myopia Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study

Brief Summary: 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.

Detailed Summary:

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 g
Sponsor: Shanghai High Myopia Study Group

Current Primary Outcome:

  • Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients [ Time Frame: 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 [ Time Frame: 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.
  • Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients [ Time Frame: 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.


Original Primary Outcome:

  • Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients [ Time Frame: 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 [ Time Frame: Follow-up until five years after surgery ]
    Cataract type and severity of age-related cataract patientsare 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 ametropic cataract patients [ Time Frame: 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.


Current Secondary Outcome: Genetic diversity based on biological specimen samples of three groups [ Time Frame: Analyzed within six months after surgery ]

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, compared to age-related cataract and ametropic cataract patients.


Original Secondary Outcome: Genetic diversity based on biospecimen samples of three groups [ Time Frame: Analyzed within six months after surgery ]

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, compared to age-related cataract and ametropic cataract patients.


Information By: Shanghai High Myopia Study Group

Dates:
Date Received: January 23, 2017
Date Started: January 1, 2015
Date Completion: December 31, 2025
Last Updated: February 26, 2017
Last Verified: February 2017