Clinical Trial: Shanghai Pediatric Cataract Study

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

Official Title: Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract 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 pediatric cataract patients, including congenital and traumatic cataract. We will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of pediatric cataract.

Detailed Summary:
Sponsor: Evidence Based Cataract Study Group

Current Primary Outcome:

  • Differences in the visual outcomes of pediatric cataract patients. [ Time Frame: Follow-up until ten years after surgery. ]
    Visual outcomes are evaluated including visual acuity with or without correction, refractive changes, intraocular pressure, fundus function, fixation type, vision development, growth of axial length, contrast sensitivity and other visual outcome measurements.
  • Genetic diversity based on biospecimen samples of pediatric cataract patients. [ Time Frame: Analyzed within six months after surgery. ]
    Sequencing of 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 congenital cataract patients, compared to traumatic cataract patients.Samples of blood, aqueous humor, anterior capsular membranes and lens tissues were applied for the genetic analysis.


Original Primary Outcome: Same as current

Current Secondary Outcome: Differences in the clinical phenotypes of pediatric cataract patients. [ Time Frame: Evaluated before receiving the cataract surgery. ]

Cataract type and severity of ametropic cataract patients are evaluated and images are captured before receiving the cataract surgery.


Original Secondary Outcome: Same as current

Information By: Evidence Based Cataract Study Group

Dates:
Date Received: February 21, 2017
Date Started: January 1, 2009
Date Completion: December 31, 2029
Last Updated: February 21, 2017
Last Verified: February 2017