Shanghai High Myopia Study

Cataract Clinical Trial

Official title:

Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062085
• Other study ID #: NSFC-81670835
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2040

Study information

• Verified date: April 2024
• Source: Shanghai High Myopia 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 high myopic cataract and age-related cataract patients. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of high myopic cataract.

Description:

High myopic cataract (HMC) has become a major high-risky type of cataract in China, which accounts for nearly 30% of cataract in recent years. Compared to age-related cataract, HMC is characterized with earlier onset, severer lens opacities, higher incidence of vitreoretinopathy and postoperative complications compared to age-related cataract(ARC).

The main purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, when compared to those age-matched ARC patients.

On the other hand, due to the lack of research in the pathogenesis of HMC, it is difficult for the investigators to precisely evaluate its risk and prognosis, and to improve its prevention and treatment. The previous study of investigators majored in a large-sample analysis on the clinical features and related genes of HMC. After preliminary screening, eight genes were selected for further investigation: 1) genes related to pathogenesis of HMC: CRYAA/ GSTP1/ TXNRD2;2) genes related to vitreoretinopathy: MCP1/ VEGFA/ CFH; 3) genes related to postoperative complications: TGFB2/ CERS2. In the present study, in order to establish a risk model of HMC from the aspect of precision medicine, the investigators are preparing to set up a comprehensive clinical database for further sequencing of selected 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 HMC.

The research aim to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, to thoroughly illustrate the influence of HMC-related genes to its prognosis and to elucidate the pathogenesis of HMC, for further promotion in the disease prevention and prognosis as well.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60000
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of cataract

• Must be able to cooperate with the ophthalmic examination

Exclusion Criteria:

• Clinical diagnosis of mental illness

• Mentally disabled

Related Conditions & MeSH terms

• Cataract
• Genetic Anticipation
• High Myopia
• Myopia
• Visual Outcome

Intervention

Other:
• Cataract
The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai High Myopia Study Group	Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in the surgical procedure of three groups	To compare the difference in the surgical procedure of three groups.	Recorded on the surgery day for further analysis
Other	Difference in the Diagnostic test of three groups	To compare the difference in the diagnostic test of three groups.	Recorded before the surgery day for further analysis
Other	Difference in the complications of the cataract surgery of three groups	To compare the prevalence of complications of the cataract surgery in HMC,ARC and ametropic cataract patients.	Follow-up until five years after surgery
Primary	Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients	Cataract type and severity of high myopic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.	Follow-up until five years after surgery
Primary	Differences in the clinical phenotypes and visual outcomes of age-related cataract patients	Cataract type and severity of age-related cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.	Follow-up until five years after surgery
Primary	Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients	Cataract type and severity of ametropic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.	Follow-up until five years after surgery
Secondary	Genetic diversity based on biological specimen samples of three groups	Sequencing of selected 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 HMC, compared to age-related cataract and ametropic cataract patients.	Analyzed within six months after surgery