Shanghai High Myopia Study

Sponsor
Shanghai High Myopia Study Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT03062085
Collaborator
Eye & ENT Hospital of Fudan University (Other)
60,000
1
132
454.6

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study
Actual Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients [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.

  2. Differences in the clinical phenotypes and visual outcomes of age-related cataract patients [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.

  3. Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients [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.

Secondary Outcome Measures

  1. Genetic diversity based on biological specimen samples of three groups [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.

Other Outcome Measures

  1. Difference in the surgical procedure of three groups [Recorded on the surgery day for further analysis]

    To compare the difference in the surgical procedure of three groups.

  2. Difference in the Diagnostic test of three groups [Recorded before the surgery day for further analysis]

    To compare the difference in the diagnostic test of three groups.

  3. Difference in the complications of the cataract surgery of three groups [Follow-up until five years after surgery]

    To compare the prevalence of complications of the cataract surgery in HMC,ARC and ametropic cataract patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of cataract

  • Must be able to cooperate with the ophthalmic examination

Exclusion Criteria:
  • Clinical diagnosis of mental illness

  • Mentally disabled

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye and ENT Hospital of Fudan University Shanghai Shanghai China 200031

Sponsors and Collaborators

  • Shanghai High Myopia Study Group
  • 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: Yu Du, B.S., Eye and ENT Hospital of Fudan University
  • Principal Investigator: Yinglei Zhang, M.D., 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai High Myopia Study Group
ClinicalTrials.gov Identifier:
NCT03062085
Other Study ID Numbers:
  • NSFC-81670835
First Posted:
Feb 23, 2017
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022