" En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials
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
- 否
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)
干预措施: spectral domain optical coherence tomography (Device)
"En face" OCT (C-scan)
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
