Shanghai Pediatric Cataract Study

Recruiting

• Conditions: Pediatric Cataract; Congenital Cataract; Traumatic Cataract; Visual Outcome; Genetic Anticipation
• Interventions: Procedure: intraocular lens implantation

• Registration Number: NCT03063216
• Lead Sponsor: Evidence Based Cataract Study Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11
• Primary Completion: 2035-12-31
• Study Completion: 2045-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Congenital cataract group	intraocular lens implantation	Cataract patients diagnosed with congenital cataract.
Traumatic cataract group	intraocular lens implantation	Cataract patients diagnosed with traumatic cataract.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Eye and ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China