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Trial record 43 of 1150 for:    cataract

Shanghai High Myopia Study

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ClinicalTrials.gov Identifier: NCT03062085
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
Eye & ENT Hospital of Fudan University
Information provided by (Responsible Party):
Shanghai High Myopia Study Group

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
High Myopia Cataract Visual Outcome Genetic Anticipation 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 [Patient Registry]
Estimated Enrollment : 60000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Blood samples from HMC, ARC and anisometropia patients collected before the cataract surgery. Aqueous humor and capsular membranes samples from HMC, ARC and ametropic cataract patients collected during the cataract surgery.


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Clinical diagnosis of mental illness
  • Mentally disabled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062085


Contacts
Contact: Yi Lu, M.D. (86)021-64377134 luyieent@163.com

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

Responsible Party: Shanghai High Myopia Study Group
ClinicalTrials.gov Identifier: NCT03062085     History of Changes
Other Study ID Numbers: NSFC-81670835
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cataract
Myopia
Anticipation, Genetic
Lens Diseases
Eye Diseases
Refractive Errors
Genetic Predisposition to Disease
Disease Susceptibility
Disease Attributes
Pathologic Processes