Shanghai High Myopia Study

May 6, 2026 updated by: Shanghai High Myopia Study Group

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Recruiting
        • Eye and ENT Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Follow-up until five years after surgery
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
Time Frame: Follow-up until five years after surgery
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
Time Frame: Follow-up until five years after surgery
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
Time Frame: Analyzed within six months after surgery
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
Time Frame: Recorded on the surgery day for further analysis
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
Time Frame: Recorded before the surgery day for further analysis
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
Time Frame: Follow-up until five years after surgery
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2045

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)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Cataract

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe