Use of a Portable Pupillometer to Detect Optic Nerve Impairment in Patients With Suspected Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Comparison of pupil diameter at myosis between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected by MRI, VEP and OCT)
研究概览
简要总结
In the diagnosis work-up of inflammatory disorders of the central nervous system (CNS), the assessment of optic nerve impairments, even in the absence of clinical symptoms, is now systematic, as it may shorten the time to diagnosis and facilitate early treatment initiation.
Currently, optic nerve impairments can be assessed using three paraclinical examinations, namely magnetic resonance imaging (MRI), visual evoked potentials (VEP) or optic coherence tomography (OCT). However, these investigations are complex and resource-intensive. The development of a simple, reliable and easily accessible clinical tool could therefore facilitate the detection of optic nerve impairments.
Unilateral or asymmetric optic nerve impairments, which are commonly observed in patients with inflammatory disorders of the CNS, translate into a reduction in efficiency of the pupillary light reflex, that can be detected by pupillometry. This technique consists in measuring pupil diameter and its variations and could represent a simple and convenient alternative to conventional investigations.
The aim of this study is therefore to compare the results obtained using a portable pupillometer in patients suspected of having an inflammatory disorder of the CNS, with and without optic nerve impairment as detected by conventional methods (MRI, VEP and OCT).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 - 60 years old
- •Patients sent to the CRC-SEP structure of the Nice hospital (CHU) with suspicion of a demyelinating disease
- •Patients who underwent brain MRI with dedicated orbital sequences
- •Patients who underwent a diagnostic work-up including VEP and OCT
- •Patients affiliated to a social security system
- •Patients who did not oppose to his participation in the clinical trial
排除标准
- •Neurological or ophtamological history that could interfere with the interpretation of neuro-ophtalmological tests.
研究组 & 干预措施
Patients with Suspicion of Demyelinating Diseases
干预措施: Pupillometry measures (Diagnostic Test)
结局指标
主要结局
Comparison of pupil diameter at myosis between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected by MRI, VEP and OCT)
时间窗: Baseline
Pupil diameter at myosis measured with a portable pupillometer.
次要结局
- Comparison of pupil diameter at mydriasis between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected by MRI, VEP and OCT)(Baseline)
- Comparison of pupillary reflex-generated constriction between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected with MRI, VEP and OCT).(Baseline)
- Comparison of anisocories between patients suspected of having a demyelinating disease with an optic nerve impairment and those with no optic nerve impairment (as detected with MRI, VEP and OCT)(Baseline)
- Correlation between pupillometry-measured pupil diameter at myosis and traditional visual acuity(Baseline)
- Correlation between pupillometry-measured pupil diameter at myosis and low contrast visual acuity(Baseline)
- Correlation between pupillometry-measured pupil diameter at myosis and the existence or not of color vision abnormalities(Baseline)
- Correlation between pupillometry-measured pupil diameter at myosis and the Retinal Nerve Fiber Layer (RNFL) thickness(Baseline)
- Correlation between pupillometry-measured pupil diameter at myosis and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness(Baseline)
- Correlation between pupillometry-measured pupil diameter at myosis and the P100 wave latency(Baseline)
- Correlation between pupillometry-measured pupil diameter at myosis and VEP amplitudes.(Baseline)
- Comparison of the frequencies of optic nerve impairments depending on the final diagnosis.(Once the final diagnosis is known.)
- Correlation between pupillometry-measured pupil diameter at mydriasis with traditional visual acuity(Baseline)
- Correlation between pupillometry-measured QPi score with traditional visual acuity(Baseline)
- Correlation between pupillometry-measured anisocory with traditional visual acuity(Baseline)
- Correlation between pupillometry-measured pupil diameter at mydriasis and low contrast visual acuity(Baseline)
- Correlation between pupillometry-measured QPi score and low contrast visual acuity(Baseline)
- Correlation between pupillometry-measured anisocory and low contrast visual acuity(Baseline)
- Correlation between pupillometry-measured pupil diameter at mydriasis and the existence or not of color vision abnormalities(Baseline)
- Correlation between pupillometry-measured QPi score and the existence or not of color vision abnormalities(Baseline)
- Correlation between pupillometry-measured anisocory and the existence or not of color vision abnormalities(Baseline)
- Correlation between pupillometry-measured pupil diameter at mydriasis and the Retinal Nerve Fiber Layer (RNFL) thickness(Baseline)
- Correlation between pupillometry-measured QPi score and the Retinal Nerve Fiber Layer (RNFL) thickness(Baseline)
- Correlation between pupillometry-measured anisocory and the Retinal Nerve Fiber Layer (RNFL) thickness(Baseline)
- Correlation between pupillometry-measured pupil diameter at mydriasis and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness(Baseline)
- Correlation between pupillometry-measured QPi score and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness(Baseline)
- Correlation between pupillometry-measured anisocory and the Ganglion Cell - Inner Plexiform Layer (GCIPL) thickness(Baseline)
- Correlation between pupillometry-measured pupil diameter at mydriasis and the P100 wave latency(Baseline)
- Correlation between pupillometry-measured QPi score and the P100 wave latency(Baseline)
- Correlation between pupillometry-measured anisocory and the P100 wave latency(Baseline)
- Correlation between pupillometry-measured pupil diameter at mydriasis and VEP amplitudes.(Baseline)
- Correlation between pupillometry-measured QPi score and VEP amplitudes.(Baseline)
- Correlation between pupillometry-measured anisocory and VEP amplitudes.(Baseline)