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临床试验/NCT04498000
NCT04498000已完成不适用

Analysis of the Pachychoroid Phenotype in an Asian Population

Singapore National Eye Centre2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2020年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
Assess the chronology of choroidal changes in patients

研究概览

简要总结

The understanding of pachychoroid phenotype is incomplete. It is important to understand the risk of conversion from an uncomplicated pachychoroid phenotype to the pachychoroid disease phenotype, to guide appropriate management of these patients.

详细描述

The progression of uncomplicated pachychoroid phenotype to pachychoroid disease is not well established and the pathophysiology of these phenotypes remains unknown: specifically if the occurence of pachyvessels is the primary event, or develops secondary to the inner choroidal attenuation.

A longitudinal study of the pachychoroid phenotype will provide much needed information regarding the natural history of the pachychoroid phenotype. Secondly, a detailed chronicle of the choroidal alterations in the pachychoroid disease spectrum may yield insights into the pathogenesis, and facilitate the development of disease modulation strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of uncomplicated and/or non-neovascular pachychoroid phenotype in at least one eye.
  • Subfoveal choroidal thickness >300 microns on enhanced depth imaging optical coherence tomography for at least one eye
  • Male or female patients above 45 years of age
  • Willingness to undergo pupil dilation, and protocol- required procedures for both eyes
  • Willing to provide written informed consent

排除标准

  • Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including Spectral domain- optical coherence tomography during the study period
  • Pregnant or nursing women

结局指标

主要结局

Assess the chronology of choroidal changes in patients

时间窗: 2 years

Determine the occurence of pachyvessles is the primary event, or consequent to inner choroidal attenuation

Incidence of progression of pachychoroid phenotypes in 2 subtypes

时间窗: 2 years observation

Two subtypes of pachychoroid phenotypes: 1. from an uncomplicated pachychoroid phenotype, to a pachychoroid disease entity 2. from non neo-vascular pachychoroid disease, to neovascular pachychoroid disease

Risk factors for progression in 2 subtypes of pachychoroid phenotypes

时间窗: 2 years

1. from an uncomplicated pachychoroid phenotype, to a pachychoroidal disease entity 2. from neo-vascular pachychoroid disease, to neovascular pachychoroid disease

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gemmy Cheung Chui Ming

Professor

Singapore National Eye Centre

研究点 (2)

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