Shanghai Pediatric Cataract Study

Congenital Cataract Clinical Trial

Official title:

Visual Outcome Evaluation and Genetic Analysis: Shanghai Pediatric Cataract Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03063216
• Other study ID #: SH-PCS
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: December 31, 2045

Study information

• Verified date: September 2023
• Source: Evidence Based Cataract Study Group
• Contact: Yi Lu, M.D.
• Phone: (86)021-64377134
• Email: luyieent[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2045
• Est. primary completion date: December 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 20 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Eye and ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Evidence Based Cataract Study Group	Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Follow-up until ten years after surgery.
Primary	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.	Analyzed within six months after surgery.
Secondary	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.	Evaluated before receiving the cataract surgery.