NCT05300698招募中不适用
MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- description of concordance and discordance of ultrasound ocular and MRI
研究概览
简要总结
D0: inclusion visit
- information
- Realization of the ocular ultrasound (care)
- Collection of consent
- Realization of high resolution MRI with injection of contrast product (duration of 30 minutes) For the realization of the MRI, the contrast product used is the gadobutrol. The dose, the lowest allowing an enhancement of sufficient contrast for diagnostic purposes (0.1 mmol/kg body mass body), is administered as a bolus intravenously in the lying patient. The MRI examination can begin immediately after injection. The patient should be monitored for at least half an hour after this, the majority of undesirable effects occurring at the during this period. The indication of ocular ultrasound and ophthalmological follow-up of the patient up to 1 month after inclusion will be collected at from their medical records.
详细描述
D0: inclusion visit
- information
- Realization of the ocular ultrasound (care)
- Collection of consent
- Realization of high resolution MRI with injection of contrast product (duration of 30 minutes) For the realization of the MRI, the contrast product used is the gadobutrol. The dose, the lowest allowing an enhancement of sufficient contrast for diagnostic purposes (0.1 mmol/kg body mass body), is administered as a bolus intravenously in the lying patient. The MRI examination can begin immediately after injection. The patient should be monitored for at least half an hour after this, the majority of undesirable effects occurring at the during this period. The indication of ocular ultrasound and ophthalmological follow-up of the patient up to 1 month after inclusion will be collected at from their medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient over 18 years old
- •Addressed in imaging for the realization of an ultrasound diagnostic eye
- •Express consent to participate in the study
- •Member of or beneficiary of a social security scheme
排除标准
- •Patient with an absolute or relative contraindication to MRI (pacemaker or neurosensory stimulator or defibrillator implantable; ocular or cerebral ferromagnetic foreign body; claustrophobia)
- •Absolute or relative contraindication to the injection of gadolinium (history of an allergic reaction to a product of contrast, bronchial asthma, allergic terrain, renal failure with serum creatinine clearance <30 mL/min)
- •Patient benefiting from a legal protection measure
- •Pregnant or breastfeeding woman: a pregnancy test in the woman of childbearing age is to be carried out before inclusion
结局指标
主要结局
description of concordance and discordance of ultrasound ocular and MRI
时间窗: 1 DAY
次要结局
未报告次要终点
研究者
研究点 (2)
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