Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Relation With Visual Field Loss in Fabry Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Blood Oxygenation at the Optic Nerve Head
研究概览
简要总结
This study aims to evaluate blood oxygenation at the optic nerve head in relation with visual field losses observed in many Fabry patients. Data collected will allow to evaluate if there is a link between these two entities.
Study will last up to 2 years during which a limited number of Fabry patients will be compared to a control group to confirm any relationship between blood flow and field losses, and to see if these results vary over time.
HYPOTHESIS
- Fabry patients will present significant differences in visual fields compared to control 2 There will be variability of the visual field defects on the long term but not on the short term 3 Blood oxygenation will be higher for Fabry patients 4 Blood volume at the optic nerve head will be the same for both groups.
详细描述
The first subjects who meet the following criteria will be enrolled in the study.
Inclusion criteria (Fabry group ):
-
Aged over 18 years old
-
Being diagnosed with Fabry disease
-
3 subjects will be under enzyme replacement treatment for the treatment of Fabry disease.
-
3 subjects will not receive enzyme replacement treatment
-
Is fit to give legal consent.
-
Is available for a period of 2 years
Inclusion criteria (CONTROL group ):
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Inclusion criteria (Fabry group):
- •Aged over 18 years old
- •Being diagnosed with Fabry disease
- •3 subjects will be under enzyme replacement treatment for the treatment of Fabry disease.
- •3 subjects will not receive enzyme replacement treatment
- •Is fit to give legal consent.
- •Is available for a period of 2 years
- •Inclusion criteria (CONTROL group):
- •Matched for age and sex with group A - 6 participants
- •Being healthy, with no known chronic systemic disease nor acute disease at the moment of the recruitment
- •Is fit to give legal consent.
- •Is available for a period of 2 years
排除标准
- •( both groups):
- •Presents with an active pathological ocular condition
- •Presence of an abnormal optic nerve (congenital or acquired)
- •Usage of topical ocular drug(s) at the time of selection
- •To have known allergy to topical diagnostic drugs used in this study
- •Usage of systemic medication with known effect on the visual field
研究组 & 干预措施
FABRY group
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- OSOME (oxygen flow at the optic nerve head measurement)
- Tropicamide
干预措施: Contrast sensitivity measurement (Procedure)
FABRY group
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- OSOME (oxygen flow at the optic nerve head measurement)
- Tropicamide
干预措施: Slit Lamp assessment and intra-ocular pressure measurement (Procedure)
FABRY group
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- OSOME (oxygen flow at the optic nerve head measurement)
- Tropicamide
干预措施: Visual field testing (Procedure)
FABRY group
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- OSOME (oxygen flow at the optic nerve head measurement)
- Tropicamide
干预措施: Oxygen flow at the optic nerve head measurement (Procedure)
FABRY group
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- OSOME (oxygen flow at the optic nerve head measurement)
- Tropicamide
干预措施: Tropicamide (Drug)
FABRY group
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- OSOME (oxygen flow at the optic nerve head measurement)
- Tropicamide
干预措施: OSOME (Device)
CONTROL group (Historical database)
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- oxygen flow at the optic nerve head measurement (OSOME)
- Under tropicamide
干预措施: Contrast sensitivity measurement (Procedure)
CONTROL group (Historical database)
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- oxygen flow at the optic nerve head measurement (OSOME)
- Under tropicamide
干预措施: Slit Lamp assessment and intra-ocular pressure measurement (Procedure)
CONTROL group (Historical database)
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- oxygen flow at the optic nerve head measurement (OSOME)
- Under tropicamide
干预措施: Visual field testing (Procedure)
CONTROL group (Historical database)
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- oxygen flow at the optic nerve head measurement (OSOME)
- Under tropicamide
干预措施: Oxygen flow at the optic nerve head measurement (Procedure)
CONTROL group (Historical database)
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- oxygen flow at the optic nerve head measurement (OSOME)
- Under tropicamide
干预措施: Tropicamide (Drug)
CONTROL group (Historical database)
- contrast sensitivity measurement
- slit lamp assessment and intra-ocular pressure measurement
- ocular coherence tomography at the optic nerve head
- visual field testing
- oxygen flow at the optic nerve head measurement (OSOME)
- Under tropicamide
干预措施: OSOME (Device)
结局指标
主要结局
Blood Oxygenation at the Optic Nerve Head
时间窗: 2 years
OSOME measurement of the blood oxygenation at the optic nerve head
次要结局
- Field Defect(2 years)
研究者
Langis Michaud
Professor
Université de Montréal