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临床试验/NCT02180633
NCT02180633已完成不适用

Unveiling Preclinical Idiopathic Macular Hole Formation

University of Coimbra7 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年5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
200
试验地点
7
主要终点
Macular Topography

研究概览

简要总结

A macular hole is a rupture in the macula. In terms of pathogenesis, as much as 80% are idiopathic (Idiopathic Macular Hole, IMH). The normal incidence of this condition is about 0.17%; however, there is a 10-29% chance of development of a macular hole in the fellow eye of patients suffering from unilateral macular hole.

Our hypothesis is that embedded in the topography of the retina is information that can allow for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As such, our work aims to develop a system that allows the automatic identification of these eyes.

详细描述

A macular hole is a rupture in the macula, the central portion of the retina, responsible for sharp, central vision and hence indispensable for most tasks. In terms of pathogenesis, even though some can be related to trauma, as much as 80% are idiopathic (Idiopathic Macular Hole, IMH). It is theorized that antero-posterior and tangential forces are behind this condition; however, no conclusions have been reached. While the normal incidence of this condition is about 0.17%, there is a 10-29% chance of developing a macular hole in the fellow eye of patients suffering from unilateral macular hole.

Our working hypothesis is that embedded in the topography of the retina is information that can allow for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As such, our study consists on the characterisation of the retinal topography of fellow eyes of patients with unilateral IMH but no other visible retinal pathologies, and of eyes from controls subjects in the same approximate age group. From these topographic maps we acquire a series of features (parameters), and using machine learning techniques create a system that separates eyes into one of the groups - healthy or at risk.

研究设计

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

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • normal OCT, with or without vitreous adhesion
  • fellow group: unilateral idiopathic macular hole

排除标准

  • OCT with vitreous adhesion
  • lamellar or pseudoholes
  • inner retinal surface alterations
  • myopia(>4D)
  • significative media opacity
  • previous retina photocoagulation
  • any type of intraocular surgery in the last 6 months
  • intravitreal medication
  • diabetes or neurodegenerative diseases
  • macular hole secondary to trauma

结局指标

主要结局

Macular Topography

时间窗: at 1 visit

When a patient that fits into the description of either the case or the control group comes in for a routine visit, a routine optical coherence tomography scan is performed. These scans are non-invasive and common in ophthalmological visits.

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

Rui Bernardes

Prof.

University of Coimbra

研究点 (7)

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