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Recruiting NCT03063216

Shanghai Pediatric Cataract Study

Observational Pediatric Cataract Congenital Cataract Traumatic Cataract Visual Outcome

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intraocular lens implantation.
Who it may be relevant to
Registry conditions: Pediatric Cataract, Congenital Cataract, Traumatic Cataract, Visual Outcome. Basic parameters: 2 months — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Differences in the visual outcomes of pediatric cataract patients. [Time frame: 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.]
Secondary outcome measures (1)
  • Differences in the clinical phenotypes of pediatric cataract patients. [Time frame: Evaluated before receiving the cataract surgery.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Eye and ENT Hospital of Fudan University — Shanghai

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. PMID 31246115

Identifiers

NCT: NCT03063216 · SH-PCS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗