Shanghai Pediatric Cataract Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-20
SponsorEvidence Based Cataract Study Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of pediatric cataract
Must be able to cooperate with the ophthalmic examination
Disqualifiers
Clinical diagnosis of mental illness
Mentally disabled
Trial population
Medical centre: Eye and ENT Hospital of Fudan University
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
intraocular lens implantation
Procedure/Surgery1）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
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Congenital cataract group1 intervention
Group B: Traumatic cataract group1 intervention
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Evidence Based Cataract Study Group
Lead sponsor
Eye & ENT Hospital of Fudan University
Collaborator
Source ClinicalTrials.gov