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NCT Number: NCT03063216

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.

Recruiting

Interested in participating?

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Key information

Age range

2 month–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

Keke Zhang, M.D.

CONTACT

Ruiqi Chang, M.D.

CONTACT

Wenwen He, M.D.

CONTACT

Xiangjia Zhu, M.D.

CONTACT

Yi Lu, MD

CONTACT

[email protected]

(86)021-64377134

Yinglei Zhang, M.D.

CONTACT

Yu Du, M.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraocular lens implantation

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Lu, M.D.

CONTACT

[email protected]

+86-02164377134

Sponsors and collaborators

Lead sponsor

Evidence Based Cataract Study Group

Other

Collaborators

  • Eye & ENT Hospital of Fudan University

Registry information

Official study title

Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study

Important dates

Study start
2009
Primary completion
2035
Study completion
2045
First posted
Feb 24, 2017
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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