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临床试验/NCT04222387
NCT04222387已完成不适用

Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD (Para-phenylenediamine) Type Aromatic Amines

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年12月19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
62
试验地点
2
主要终点
% of patients with MEKAR retinopathy detected on OCT-B scan

研究概览

简要总结

Hair dye products could induce minimal forms of MEKAR retinopathies (Mitogen-activated Extracellular signal-regulated Kinase - inhibitors associated retinopathies). These minimal forms of MEKAR are likely to be underdiagnosed, since the associated visual loss is usually mild and so this condition should be considered when patients report blurred vision. The aim of the study is to analyze whether in the current population that dyes the hair, minimal forms that go unnoticed by MEKAR retinopathies can be induced.

研究设计

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

  • Hair dye up to one month before the inclusion
  • Hair dye product containing aromatic amines

排除标准

  • Pregnant or lactating woman
  • Retinal pathology already known, or central serous choroiditis

结局指标

主要结局

% of patients with MEKAR retinopathy detected on OCT-B scan

时间窗: Day of inclusion, up to one month month after the last hair dye

Physiological parameter : Serous retinal detachment at the posterior pole, detected on OCT-B scan

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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