Shanghai High Myopia Study

NCT ID: NCT03062085

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2040-12-31

Brief Summary

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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

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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.

Conditions

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High Myopia Cataract Visual Outcome Genetic Anticipation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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High myopic cataract group

Cataract patients with high myopia.

Cataract

Intervention Type OTHER

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

Age-related cataract group

Age-related cataract patients.

Cataract

Intervention Type OTHER

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

Ametropic cataract group

Cataract patients with ametropia.

Cataract

Intervention Type OTHER

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

Interventions

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Cataract

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Clinical diagnosis of mental illness
* Mentally disabled
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role collaborator

Shanghai High Myopia Study Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi Lu, M.D.

Role: STUDY_CHAIR

Eye and ENT Hospital of Fudan University

Xiangjia Zhu, M.D.

Role: STUDY_DIRECTOR

Eye and ENT Hospital of Fudan University

Keke Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Wenwen He, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Yu Du, B.S.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Yinglei Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Zhennan Zhao, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Ruiqi Chang, B.S.

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Locations

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Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Lu, M.D.

Role: CONTACT

(86)021-64377134

Facility Contacts

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Yi Lu, M.D.

Role: primary

(86)021-64377134

References

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Zhang Y, Zhang S, Zhang K, Lu Y, Zhu X. Characteristics of the Corneal Endothelium in Elderly Adults with High Myopia. Phenomics. 2025 Jan 27;4(6):562-569. doi: 10.1007/s43657-024-00186-6. eCollection 2024 Dec.

Reference Type DERIVED
PMID: 40061825 (View on PubMed)

Hu X, Qi J, Cheng K, He W, Zhang K, Zhao C, Lu Y, Zhu X. Effectiveness of prophylactic capsular tension ring implantation during cataract surgery in highly myopic eyes. J Cataract Refract Surg. 2024 Oct 1;50(10):1030-1036. doi: 10.1097/j.jcrs.0000000000001495.

Reference Type DERIVED
PMID: 39313860 (View on PubMed)

He W, Wei L, Liu S, Huang Z, Qi J, Zhang K, Meng J, Du Y, Lu Y, Zhu X. Role of Optic Nerve Head Characteristics in Predicting Intraocular Pressure Spikes after Cataract Surgery in Highly Myopic Eyes. Ophthalmol Ther. 2023 Aug;12(4):2023-2033. doi: 10.1007/s40123-023-00714-z. Epub 2023 May 13.

Reference Type DERIVED
PMID: 37178442 (View on PubMed)

He W, Cheng K, Zhao L, Liu S, Huang Z, Zhang K, Du Y, Zhou X, Lu Y, Zhu X. Long-Term Outcomes of Posterior Capsular Opacification in Highly Myopic Eyes and Its Influencing Factors. Ophthalmol Ther. 2023 Aug;12(4):1881-1891. doi: 10.1007/s40123-023-00711-2. Epub 2023 May 3.

Reference Type DERIVED
PMID: 37138195 (View on PubMed)

Meng J, Chen Y, Cheng K, Qi J, Du Y, Yao Y, He W, Zhang K, Lu Y, Zhu X. LONG-TERM PROGRESSION PATTERN OF MYOPIC TRACTIONAL MACULOPATHY: Outcomes and Risk Factors. Retina. 2023 Jul 1;43(7):1189-1197. doi: 10.1097/IAE.0000000000003791.

Reference Type DERIVED
PMID: 36977327 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32161773 (View on PubMed)

Other Identifiers

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NSFC-81670835

Identifier Type: -

Identifier Source: org_study_id

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