跳至主要内容
临床试验/NCT02805686
NCT02805686已完成不适用

" En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials

Fondation Ophtalmologique Adolphe de Rothschild0 个研究点目标入组 45 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
主要终点
concordance between mfERG and "En-face" OCT

研究概览

简要总结

The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be detected at the infra-clinical state, when it can still be reversible. Identifying early retinal anatomical changes has always represented (a challenge for medical interns, dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a long and tedious exam, offered by only few medical centers. It is recommended to find a simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid (junction line between, the external and internal photoreceptor segments) using optical coherence tomography (OCT-SD) "en face" enables us, to obtain a panoramic viewing of the state of the photoreceptor layer, and to detect any modification, even subtle, within this layer. The OCT-SD "en face" can be easily done by any ophthalmologist who owns one.

The proportion of "en face" OCT-SD showing suggestive retinal damage and patients who present retinal damage in relation with synthetic antimalarial treatments and diagnosed by mfERG is considered in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • Patients treated with synthetic antimalarials with retinal damage (in relation with the antimalarial treatment) recently diagnosed by mfERG
  • Patients treated with synthetic antimalarials in the past, who stopped treatment because of a supposed retinal damage not confirmed by mfERG

排除标准

  • State of ocular structures preventing the realization of exams

研究组 & 干预措施

"En face" OCT (C-scan)

Experimental

干预措施: spectral domain optical coherence tomography (Device)

"En face" OCT (C-scan)

Experimental

干预措施: multifocal electroretinogram (Device)

结局指标

主要结局

concordance between mfERG and "En-face" OCT

时间窗: after 1 hour

measure of kappa coefficient

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

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