Shanghai High Myopia Study

Официальное название

Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients [Срок оценки: Follow-up until five years after surgery]
• Differences in the clinical phenotypes and visual outcomes of age-related cataract patients [Срок оценки: Follow-up until five years after surgery]
• Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients [Срок оценки: Follow-up until five years after surgery]

Вторичные конечные точки (1)

• Genetic diversity based on biological specimen samples of three groups [Срок оценки: Analyzed within six months after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• Clinical diagnosis of mental illness
• Mentally disabled

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Eye and ENT Hospital of Fudan University — Шанхай

Публикации

• 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. PMID 40061825
• 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. PMID 39313860
• 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. PMID 37178442
• 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. PMID 37138195
• 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. PMID 36977327
• 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. PMID 32161773

Идентификаторы

NCT: NCT03062085 · NSFC-81670835

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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