Clinical trial NCT03062085: Shanghai High Myopia Study
Official title: Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Myopia
Cataract
Visual Outcome
Genetic Anticipation
Lead sponsor: Shanghai High Myopia Study Group
Sponsor class: OTHER
Collaborators: name: Eye & ENT Hospital of Fudan University
First posted: 2017-02-23
Enrollment: 60000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cataract patients who will undergo cataract surgery in Eye and ENT Hospital of Fudan University.

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.

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.

Eligibility 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

Primary outcomes:
measure: Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients
timeFrame: Follow-up until five years after surgery
measure: Differences in the clinical phenotypes and visual outcomes of age-related cataract patients
timeFrame: Follow-up until five years after surgery
measure: Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients
timeFrame: Follow-up until five years after surgery
Secondary outcomes:
measure: Genetic diversity based on biological specimen samples of three groups
timeFrame: Analyzed within six months after surgery
Other outcomes:
measure: Difference in the surgical procedure of three groups
timeFrame: Recorded on the surgery day for further analysis
measure: Difference in the Diagnostic test of three groups
timeFrame: Recorded before the surgery day for further analysis
measure: Difference in the complications of the cataract surgery of three groups
timeFrame: Follow-up until five years after surgery
Locations:
city: Shanghai
country: China
facility: Eye and ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Yi Lu, M.D.
role: STUDY_CHAIR
affiliation: Eye and ENT Hospital of Fudan University
name: Xiangjia Zhu, M.D.
role: STUDY_DIRECTOR
affiliation: Eye and ENT Hospital of Fudan University
name: Keke Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Wenwen He, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Yu Du, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Yinglei Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Zhennan Zhao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Ruiqi Chang, B.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.