Shanghai High Myopia Study

Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Visual Outcome; High Myopia; Genetic Anticipation
• Intervention / Treatment: Other: Cataract

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 60000

Contacts and Locations

• Study Contact: Name: Yi Lu, M.D.; Phone Number: (86)021-64377134; Email: luyieent@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Eye and ENT Hospital of Fudan University
      • Contact: Yi Lu, M.D.; Phone Number: (86)021-64377134; Email: luyieent@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cataract patients who will undergo cataract surgery in Eye and ENT Hospital of Fudan University.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Clinical diagnosis of mental illness
• Mentally disabled

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High myopic cataract group; Cataract patients with high myopia.	Other: Cataract; The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.
Age-related cataract group; Age-related cataract patients.	Other: Cataract; The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.
Ametropic cataract group; Cataract patients with ametropia.	Other: Cataract; The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai High Myopia Study Group
• Collaborators: Eye & ENT Hospital of Fudan University
• Investigators: Study Chair: Yi Lu, M.D., Eye and ENT Hospital of Fudan University; Study Director: Xiangjia Zhu, M.D., Eye and ENT Hospital of Fudan University; Principal Investigator: 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: Yinglei Zhang, M.D., Eye and ENT Hospital of Fudan University; Principal Investigator: Yu Du, B.S., Eye and ENT Hospital of Fudan University; Principal Investigator: Zhennan Zhao, Ph.D., Eye and ENT Hospital of Fudan University; Principal Investigator: Ruiqi Chang, B.S., Eye and ENT Hospital of Fudan University

Publications and helpful links

General Publications

• Lu Q, He W, Qian D, Lu Y, Zhu X. Measurement of crystalline lens tilt in high myopic eyes before cataract surgery using swept-source optical coherence tomography. Eye Vis (Lond). 2020 Mar 6;7:14. doi: 10.1186/s40662-020-00176-5. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Lens Diseases; Refractive Errors; Disease Susceptibility; Genetic Predisposition to Disease; Cataract; Myopia; Anticipation, Genetic
• Other Study ID Numbers: NSFC-81670835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No