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临床试验/NCT02876393
NCT02876393已完成不适用

A Systematic Study of Retinal Structure and Function in Diabetic Macular Oedema

Queen's University, Belfast1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
Presence of DMO evaluated from the optical coherence tomography (OCT) images

研究概览

简要总结

Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to the high and fluctuating sugar levels in the blood stream. An eye with DR will have abnormal appearing retinal blood vessels which become engorged and dilated, leaky and fragile or undergo closure. The net result is a picture of haemorrhage and or ischaemia (lack of blood supply). A particular feature of DR is the accumulation of fluid in the macula which is the central part of the retina and responsible for detailed eye sight. This peculiar form of DR is called Diabetic Macular Oedema (DMO). DMO can occur in isolation without other features of DR. DMO is commoner in type 2 diabetes where insulin resistance and abnormalities of blood fats are found. The investigators wish to study DR and DMO using high resolution retinal imaging and functional tests in normal participants, those participants with diabetes without any overt signs of disease and those with DR and DMO in order to understand how the condition develops and whether there are any unique risk factors that can be identified

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Group 1 (Healthy controls without DM):
  • Persons older than 18 years without DM
  • Fundus free of any signs of retinal disease
  • Best Corrected Visual Acuity of 20/40 (73 ETDRS letters) in both eyes
  • Group 2 (Persons with DM with no retinopathy):
  • Persons with Type 1 or type 2 diabetes older than 18 years
  • Normal fundus, Absence of features of DR or DMO in both eyes
  • Best Corrected Visual Acuity 20/40 (73 ETDRS letters) in at least one eye
  • Persons with Type 1 or type 2 diabetes 18 years and older
  • Fundus signs of mild, moderate or severe DR and or DMO
  • Best Corrected Visual Acuity 20/200 (33 ETDRS letters) or better

排除标准

  • Recent ocular surgical procedures performed within the previous 3 months
  • Presence of ocular confounding disorders such as neovascular age related macular degeneration, glaucoma or active uveitis
  • Serious life threatening conditions that would preclude attendance in the longitudinal part of the study
  • Neurological conditions that can impair vision

结局指标

主要结局

Presence of DMO evaluated from the optical coherence tomography (OCT) images

时间窗: The outcome measures will be assessed at the end of 3 months

次要结局

未报告次要终点

研究者

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

Usha Chakravarthy

Professor

Queen's University, Belfast

研究点 (1)

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