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Clinical Trials/NCT05782452
NCT05782452
Completed
Not Applicable

Genetic Diagnosis and Phenotype-genotype Correlation in a Large Chinese Cohort of Congenital Cataracts

Zhongshan Ophthalmic Center, Sun Yat-sen University1 site in 1 country115 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Cataract
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment
115
Locations
1
Primary Endpoint
Whether the participant has pathogenic genes
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The prediction of genetic risk in congenital cataract patients has great clinical significance. In this trial, the investigators aim to screen the causative variants from 115 unrelated bilateral congenital cataract patients enrolled consecutively, describe novel and recurrent variants, analyze the factors affecting genetic diagnostic yield, and explore potential phenotype-genotype correlation.

Detailed Description

Determining whether the disease is hereditary and the precise genetic cause of congenital cataract has great clinical significance in guiding genetic counseling and improving clinical care pathway. Varying among studies, genetic causes account for 8.3-85% of congenital cataracts because of the difference in ethnic background, genetic screening techniques used, the percentage of patients with bilateral cataracts, with a family history, and with syndromic disease. A phenotype-genotype correlation may be used to predict the causative genes, and the involvement of other tissues and organs based on the appearance of the lens. In addition, it can be used to improve our understanding of lens biology. A phenotype-genotype correlation is difficult to establish because of the genotypic and phenotypic heterogeneity of congenital cataracts. In this trail, the investigators aim to screen the causative variants from 115 unrelated bilateral congenital cataract patients enrolled consecutively, describe novel and recurrent variants, analyze the factors affecting genetic diagnostic yield, and explore potential phenotype-genotype correlation. Facial and anterior eye segment photographs, pre- and post-operative ocular parameters, and medical and family histories were recorded. Bioinformatics analysis was performed using whole-exome sequencing data. Statistical and correlation analyses were performed using the basic characteristics, deep phenotype, and genotype data.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Weirong Chen

Prof.

Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • The participant with bilateral congenital cataract;
  • Have signed a consent form. .

Exclusion Criteria

  • The participant not identified with congenital cataract;
  • The participant with unilateral congenital cataract.

Outcomes

Primary Outcomes

Whether the participant has pathogenic genes

Time Frame: 2 years

Type of the cataracts

Time Frame: before surgery

The cataracts were categorized into 17 groups (Membranous cataract, Thin and fibrotic nuclear cataract, Nuclear cataract, Zonular cataract, Pulverulent cataract, Pocket-like cataract, "Ant egg" cataract, Cerulean cataract, Coronary cataract, Coralliform cataract, Cortical cataract, Sutural cataract, Anterior subcapsular cataract, Anterior polar cataract, Posterior subcapsular cataract, Posterior polar cataract, Total cataract)

Secondary Outcomes

  • Whether the participant has family history(2 years)
  • The symmetricity of the type of cataract(before surgery)

Study Sites (1)

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