跳至主要内容
临床试验/NCT01767038
NCT01767038已完成不适用

Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.

Centre Hospitalier Universitaire Dijon10 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2011年11月1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
202
试验地点
10
主要终点
Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT.

研究概览

简要总结

Patients with retinal detachment do not always recover good visual function. Sometimes simple causes are responsible. Other causes can only be discovered thanks to high-resolution imaging provided by the latest generation of OCT.

This study is possible thanks to surgical teams who have a strong recruitment potential, with the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude FRIENDS) to define more strict intervention criteria. The principal objective of this study is to better define with regard to time:

  • The onset of surgically curable or transient macular affections, and losses in visual acuity that can be qualified as "explained"
  • But above all to better understand the relationships between anatomical analyses obtained using OCT and autofluorescence and functional analysis using visual acuity and microperimetry.
  • In the near future, two techniques (OCT and microperimetry) will certainly become essential tools in the evaluation of macular function. Better understanding of these relationships is the first necessary step in any study concerning the therapeutic prevention of retinal lesions related to retinal detachment: This study will make it possible to define criteria for the evaluation of anatomical and functional recovery, their relationship with each other and finally their evolution over time. This is an essential first phase before possible therapies can be evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • •Patients who have provided written informed consent
  • •Retinal detachment with pre-operative raised macula, re-attached during a surgical intervention with one month of follow-up
  • •Patients undergoing surgery as the first-line treatment (ab extern surgery or gas vitrectomy)
  • •Patients who accept to be followed for at least 12 months at the investigating center.

排除标准

  • •Persons who are not registered with social security agency
  • •Macular affections pre-existent to the DR
  • •Retinal detachment requiring several interventions to obtain a reapplication
  • •Lazy eye with pre-operative
  • •Brightness of the circles not allowing the realization of the examinations

结局指标

主要结局

Relationship between functional recovery and the aspect of external layers using Spectral Domain OCT.

时间窗: At six months after the intervention

Visual acuity, integrity of the IS/OS junction of the photoreceptors and the outer limiting membrane.

次要结局

  • Peripheral deficits and quantification of hypoautofluorescent zones.(At 3, 6 and 12 months after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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