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Shanghai Pediatric Cataract Study

Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03063216
Enrollment
10000
Registered
2017-02-24
Start date
2009-01-01
Completion date
2045-12-31
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

Sponsors

Eye & ENT Hospital of Fudan University
CollaboratorOTHER
Evidence Based Cataract Study Group
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Months to 20 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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.
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

MeasureTime frameDescription
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.

Countries

China

Contacts

Primary ContactYi Lu, M.D.
luyieent@163.com+86-02164377134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026