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临床试验/NCT01153789
NCT01153789已完成不适用

Evaluation and Medical Care of Oculomotor Dysfunction Leading to Vertigo in Children

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
2
主要终点
oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test

研究概览

简要总结

The eye movements of vergence allow binocular vision whatever the viewing distance or the body movements are and the perception of depth. Vergence dysfunction can lead to erroneous visual sensation of movements. In our daily life using screens (computer, game boys..) is increasing and this approach heavily the ocular vergence and can lead to symptoms if oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate the vergence performances just evaluation in static condition is currently available in ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye movement recording to study ocular vergence in dynamic condition.

详细描述

The goals of the study are:

  1. to compare the coordination of binocular eye movements, postural stability on a force-plate during visual tasks (looking at a target or reading) and dynamic visual acuity between two groups of children and teenagers: one group with oculomotor vergence disorders and vertigo and one group with normal eye movements. Children will undergo complete vestibular testing (by Dr WIENER-VACHER) to eliminate a vestibular origin for vertigo. Normal children will be volunteers.
  2. in order to evaluate objectively the effect of rehabilitation, a second oculomotor evaluation (identical to the initial one) will be done in children with vertigo after an orthoptic rehabilitation focused on ocular vergence. We hypothesize that functional oculomotor disorders can be rehabilitated because of the plasticity of the oculomotor system (proved by several studies for many years) provided that the spatial temporal parameters of the training are precisely tailored to patient malfunction.
  3. Establish normative data of the binocular eye movements and posturography, and validate a protocol for complete static and dynamic oculomotor evaluation for clinical use. To a longer term modification of the rehabilitation protocols of eye movements will be designed to fit each patient problems in function of the abnormalities revealed by the static and dynamic evaluation.

Study calendar :

All the children referred for vertigo with vergence abnormalities and normal vestibular functional evaluation will be proposed for participate to the study.

The patients included in the study will perform an oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test. These tests will last for 60 minutes, including breaks to avoid fatigue of the children. Then, the children will follow orthoptic rehabilitation :12 sessions (2 sessions per week). These sessions will be done by an orthoptist installed close to home, in contact with the research team.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with disorders of vergence:
  • 6 to 17 years old
  • Patient receiving a social security scheme
  • Presenting vergence problems (diagnosed by standard methods : prism bar using the proximal point of convergence and phoria) and suffering from vertigo and/or headache
  • Presenting anormal refraction
  • Free from any type vestibular pathology, ENT or neurological
  • Free from strabismus
  • Child and holders of parental authority have signed a consent
  • Healthy Children :
  • 6 to 17 years old
  • Free from any type of vestibular pathology, ENT or neurological
  • Free from any type of neuron-ophthalmic/orthoptic pathology
  • Child and holders of parental authority have signed a consent

排除标准

  • Patient with a disease which (from the assessment of the investigator) could disrupt the monitoring or be disrupted by the participation in the study,

结局指标

主要结局

oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test

时间窗: t=0, t=3months, t=6months

次要结局

  • free of symptoms(t=3months, t=6months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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