Shanghai Pediatric Cataract Study

NCT03063216 | Recruiting

• 1 other identifier: SH-PCS
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Differences in the clinical phenotypes of pediatric cataract patients.

  Evaluated before receiving the cataract surgery.

Study Arms (2)

Congenital cataract group

Cataract patients diagnosed with congenital cataract.

Procedure: intraocular lens implantation

Traumatic cataract group

Cataract patients diagnosed with traumatic cataract.

Procedure: intraocular lens implantation

Interventions

intraocular lens implantation PROCEDURE

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

Congenital cataract group; Traumatic cataract group

Eligibility Criteria

• Age: 2 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Medical centre: Eye and ENT Hospital of Fudan University

You may qualify if:

• Clinical diagnosis of pediatric cataract
• Must be able to cooperate with the ophthalmic examination

You may not qualify if:

• Clinical diagnosis of mental illness
• Mentally disabled

Sponsors & Collaborators

• Evidence Based Cataract Study Group: lead
• Eye & ENT Hospital of Fudan University: collaborator

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples of blood, aqueous humor, anterior capsular membranes and lens tissues from pediatric cataract patients.

MeSH Terms

Conditions

Anticipation, Genetic

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yi Lu, M.D.

  Eye and ENT Hospital of Fudan University

  STUDY CHAIR

• Xiangjia Zhu, M.D.

  Eye and ENT Hospital of Fudan University

  STUDY DIRECTOR

• Keke Zhang, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Wenwen He, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Yu Du, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Yinglei Zhang, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Ruiqi Chang, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lu, M.D.

CONTACT

+86-02164377134; luyieent@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: January 1, 2009
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2045
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CN (1)