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亚洲年龄相关性黄斑变性表型研究:一项前瞻性队列研究的原理、设计和方案。

Asian age-related macular degeneration phenotyping study: rationale, design and protocol of a prospective cohort study.

机构信息

Singapore Eye Research Institute, Singapore National Eye Centre, 11 Third Hospital Avenue, Singapore.

出版信息

Clin Exp Ophthalmol. 2012 Sep-Oct;40(7):727-35. doi: 10.1111/j.1442-9071.2012.02765.x. Epub 2012 Apr 9.

Abstract

BACKGROUND

Current knowledge of the phenotypic characteristics (e.g. clinical features, risk factors, natural history and treatment response) of age-related macular degeneration (AMD) in Asians remains limited. This report summarizes the rationale and study design of a prospective observational study of Asian neovascular AMD, including polypoidal choroidovasculopathy variant.

DESIGN

The Asian AMD phenotyping study is a prospective, observational clinical study of Asian patients with neovascular AMD or polypoidal choroidovasculopathy in three tertiary eye centres in Singapore.

PARTICIPANTS

The study aims to recruit 500 consecutive patients from the retinal clinics of three tertiary eye centres in Singapore.

METHODS

Standardized examination procedures include interviews, a comprehensive eye examination, digital photography of the retina, fundus fluorescein and indocyanine green angiography and spectral domain optical coherence tomography using a standardized protocol. Blood samples were collected for biochemical analyses and stored for genetic and proteomic studies.

MAIN OUTCOME MEASURES

The aim of the study was to build a comprehensive database of clinical, angiographic, functional and natural history data of Asian AMD over a 12-month follow-up period.

RESULTS

This article discusses the methodology and design of this prospective multi-centred study.

CONCLUSION

This study will provide in-depth longitudinal data of the evolution of clinical features, risk factors, natural history and treatment pattern and response of Asian AMD and polypoidal choroidovasculopathy, allowing unique insights into pathogenesis and the design of new treatment strategies.

摘要

背景

目前亚洲人年龄相关性黄斑变性(AMD)的表型特征(如临床特征、危险因素、自然病程和治疗反应)的知识仍然有限。本报告总结了一项亚洲新生血管性 AMD 前瞻性观察研究的基本原理和研究设计,包括息肉样脉络膜血管病变变异型。

设计

亚洲 AMD 表型研究是一项在新加坡三家三级眼科中心对亚洲新生血管性 AMD 或息肉样脉络膜血管病变患者进行的前瞻性、观察性临床研究。

参与者

该研究旨在从新加坡三家三级眼科中心的视网膜诊所招募 500 名连续患者。

方法

标准化检查程序包括访谈、全面眼科检查、视网膜数字摄影、眼底荧光素和吲哚青绿血管造影以及使用标准化方案的谱域光相干断层扫描。采集血样进行生化分析,并储存用于遗传和蛋白质组学研究。

主要观察指标

该研究的目的是在 12 个月的随访期间建立亚洲 AMD 的临床、血管造影、功能和自然病史综合数据库。

结果

本文讨论了这项前瞻性多中心研究的方法学和设计。

结论

该研究将提供亚洲 AMD 和息肉样脉络膜血管病变临床特征、危险因素、自然病程和治疗模式及反应演变的深入纵向数据,从而深入了解发病机制并设计新的治疗策略。

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