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RecruitingNCT03063216Updated Sep 27, 2024

Shanghai Pediatric Cataract Study

An observational study in Pediatric Cataract, Congenital Cataract and Traumatic Cataract, sponsored by Evidence Based Cataract Study Group. Recruiting at 1 site in China. Open to participants aged 2 Months to 20 Years. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by Evidence Based Cataract Study Group · Observational

From the registry’s dates

  • Started Jan 2009; still recruiting 17 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10,000
Ages
2 Months to 20 Years
Sex
All
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Study 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.

02

Conditions studied

  • Pediatric Cataract
  • Congenital Cataract
  • Traumatic Cataract
  • Visual Outcome
  • Genetic Anticipation

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Evidence Based Cataract Study Group is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Months to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Medical centre: Eye and ENT Hospital of Fudan University

Inclusion criteria

  • Clinical diagnosis of pediatric cataract
  • Must be able to cooperate with the ophthalmic examination

Exclusion criteria

Exclusion Criteria:

  • Clinical diagnosis of mental illness
  • Mentally disabled
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Congenital cataract group

    Cataract patients diagnosed with congenital cataract.

    Procedure: intraocular lens implantation

  • Traumatic cataract group

    Cataract patients diagnosed with traumatic cataract.

    Procedure: intraocular lens implantation

Interventions

  • Procedureintraocular 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

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What researchers measure

Primary outcomes

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

    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.

    Time frame: Follow-up until ten years after surgery.

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

    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.

    Time frame: Analyzed within six months after surgery.

Secondary outcomes

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

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

    Time frame: Evaluated before receiving the cataract surgery.

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Study locations

1 of 1 sites recruiting
  • Eye and ENT Hospital of Fudan University
    Shanghai, Shanghai 200031, China
    • Yi Lu, MD · Contact · luyieent@163.com · (86)021-64377134
    • 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. · Contact
    Recruiting
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References and documents

Publications

  • Zhu X, He W, Du Y, Kraus CL, Xu Q, Sun T, Yu J, Lu Y. Presence of Posterior Staphyloma in Congenital Cataract Children. Curr Eye Res. 2019 Dec;44(12):1319-1324. doi: 10.1080/02713683.2019.1637437. Epub 2019 Jul 5. PubMed 31246115 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03063216
Lead sponsor
Evidence Based Cataract Study Group
Collaborators
Eye & ENT Hospital of Fudan University
Responsible party
Sponsor
First posted
Feb 24, 2017
Start date
Jan 1, 2009
Primary completion
Dec 31, 2035 (estimated)
Completion
Dec 31, 2045 (estimated)
Last update
Sep 27, 2024

Study contacts

Yi Lu, M.D.
Contact
luyieent@163.com
+86-02164377134
Yi Lu, M.D.
study chair · Eye and ENT Hospital of Fudan University
Xiangjia Zhu, M.D.
study director · Eye and ENT Hospital of Fudan University
Keke Zhang, M.D.
principal investigator · Eye and ENT Hospital of Fudan University
Wenwen He, M.D.
principal investigator · Eye and ENT Hospital of Fudan University
Yu Du, M.D.
principal investigator · Eye and ENT Hospital of Fudan University
Yinglei Zhang, M.D.
principal investigator · Eye and ENT Hospital of Fudan University
Ruiqi Chang, M.D.
principal investigator · Eye and ENT Hospital of Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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