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NCT Number: NCT03062085

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.

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Key information

Conditions

High Myopia Anticipation, Genetic Cataract Disease Attributes Disease Susceptibility Eye Diseases Genetic Anticipation Genetic Predisposition to Disease Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Visual Outcome

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

Yi Lu, M.D.

CONTACT

[email protected]

(86)021-64377134

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Clinical diagnosis of mental illness
  • Mentally disabled

Treatment and study plan

Cataract

Other

The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Lu, M.D.

CONTACT

[email protected]

(86)021-64377134

Sponsors and collaborators

Lead sponsor

Shanghai High Myopia Study Group

Other

Collaborators

  • Eye & ENT Hospital of Fudan University

Registry information

Official study title

Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study

Important dates

Study start
2015
Primary completion
2035
Study completion
2045
First posted
Feb 23, 2017
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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