Shanghai Pediatric Cataract Study

September 25, 2024 updated by: Evidence Based Cataract Study Group

Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Eye and ENT Hospital of Fudan University
        • Contact:
        • Contact:
          • Xiangjia Zhu, M.D.
        • Contact:
          • Keke Zhang, M.D.
        • Contact:
          • Wenwen He, M.D.
        • Contact:
          • Yu Du, M.D.
        • Contact:
          • Yinglei Zhang, M.D.
        • Contact:
          • Ruiqi Chang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Medical centre: Eye and ENT Hospital of Fudan University

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Congenital cataract group
Cataract patients diagnosed with congenital cataract.
Procedure: intraocular lens implantation
1）Pediatric cataract patients with intraocular lens implantation and those without intraocular lens implantation；2）Traumatic cataract patients with intraocular lens implantation and those without intraocular lens implantation
Traumatic cataract group
Cataract patients diagnosed with traumatic cataract.
Procedure: intraocular lens implantation
1）Pediatric cataract patients with intraocular lens implantation and those without intraocular lens implantation；2）Traumatic cataract patients with intraocular lens implantation and those without intraocular lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow-up until ten years after surgery.
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.
Analyzed within six months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluated before receiving the cataract surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidence Based Cataract Study Group

Collaborators

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Yu Du, M.D., Eye and ENT Hospital of Fudan University
  • Principal Investigator: Ruiqi Chang, M.D., Eye and ENT Hospital of Fudan University
  • 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: Yinglei Zhang, M.D., Eye and ENT Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2045

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-PCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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