Clincosm LogoSign in Get a demo

Shanghai Pediatric Cataract Study

Sponsor
Evidence Based Cataract Study Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT03063216
Collaborator
Eye & ENT Hospital of Fudan University (Other)
10,000
Enrollment
1
Location
323.9
Anticipated Duration (Months)
30.9
Patients Per Site Per Month

Study Details

Study Description

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 participants, including congenital and traumatic cataract. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of pediatric cataract.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study
    Actual Study Start Date :
    Jan 1, 2009
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2035

    Arms and Interventions

    Arm Intervention/Treatment
    Congenital cataract group

    Cataract patients diagnosed with congenital cataract.
    Traumatic cataract group

    Cataract patients diagnosed with traumatic cataract.

    Outcome Measures

    Primary Outcome Measures

    1. Differences in the visual outcomes of pediatric cataract patients. [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.

    2. Genetic diversity based on biospecimen samples of pediatric cataract patients. [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.

    Secondary Outcome Measures

    1. Differences in the clinical phenotypes of pediatric cataract patients. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of pediatric cataract

    • Must be able to cooperate with the ophthalmic examination

    Exclusion Criteria:

    • Clinical diagnosis of mental illness

    • Mentally disabled

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye and ENT Hospital of Fudan University Shanghai Shanghai China 200031

    Sponsors and Collaborators

    • Evidence Based Cataract Study Group
    • Eye & ENT Hospital of Fudan University

    Investigators

    • Study Chair: Yi Lu, M.D., Eye and ENT Hospital of Fudan University
    • Study Director: Xiangjia Zhu, M.D., Eye and ENT Hospital of Fudan University
    • Principal Investigator: Keke Zhang, M.D., Eye and ENT Hospital of Fudan University
    • Principal Investigator: Wenwen He, M.D., Eye and ENT Hospital of Fudan University
    • Principal Investigator: Yu Du, M.D., Eye and ENT Hospital of Fudan University
    • Principal Investigator: Yinglei Zhang, M.D., Eye and ENT Hospital of Fudan University
    • Principal Investigator: Ruiqi Chang, M.D., Eye and ENT Hospital of Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Evidence Based Cataract Study Group
    ClinicalTrials.gov Identifier:
    NCT03063216
    Other Study ID Numbers:
    • SH-PCS
    First Posted:
    Feb 24, 2017
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Anticipation, Genetic

    Study Results

    No Results Posted as of Mar 24, 2022