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Study of Oculomotor Dysfunction Leading to Children Vertigo (VERVE)

This study is currently recruiting participants.
Verified May 2010 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
France: Centre National de la Recherche Scientifique
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01153789
First received: June 29, 2010
Last updated: March 16, 2012
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Vertigo
Headache
Anomaly of Vergence System
Accommodation Disorders
Orthoptic Rehabilitation
 Procedure: orthoptic rehabilitation
Other: Orthoptic diagnostic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation and Medical Care of Oculomotor Dysfunction Leading to Vertigo in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test [ Time Frame: t=0, t=3months, t=6months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • free of symptoms [ Time Frame: t=3months, t=6months ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: September 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Children with vertigo-headache and vergence disorders
 Procedure: orthoptic rehabilitation
Orthoptic rehabilitation: 12 sessions (2 sessions per week) At the end of a series of 12 sessions of orthoptic, the child will be examined and will again perform an static and dynamic oculomotor evaluation and control of postural balance.
Other Name: orthoptic rehabilitation
No Intervention: Control
Healthy controls
 Other: Orthoptic diagnostic
postural, oculomotor and orthoptics tests
Other Name: Orthoptic diagnostic

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient with a disease which (from the assessment of the investigator) could disrupt the monitoring or be disrupted by the participation in the study,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153789

Contacts
Contact: Sylvette R WIENER, M.D., PhD +33 1 40 03 24 79 sylvette.wiener@rdb.aphp.fr
Contact: Marylène LABEGUERIE +33 1 40 03 47 38 marylene.labeguerie@rdb.aphp.fr

Locations
France
ORL Service - Robert Debre Hospital Recruiting
Paris, France, 75019
Contact: Sylvette WIENER, M.D., PhD     +33 1 40 03 24 79     sylvette.wiener@rdb.aphp.fr    
Contact: Marylène LABEGUERIE     +33 1 40 03 47 38     marylene.labeguerie@rdb.aphp.fr    
Principal Investigator: Sylvette WIENER, M.D., PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
France: Centre National de la Recherche Scientifique
Investigators
Principal Investigator: Sylvette R WIENER, M.D., PhD Assistance Publique - Hôpitaux de Paris
Study Director: Thierry VAN DEN ABBEELE, M.D., PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01153789     History of Changes
Other Study ID Numbers: P081114
Study First Received: June 29, 2010
Last Updated: March 16, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Vergence-accommodation evaluation
Vergence and postural control
Dynamic visual acuity

Additional relevant MeSH terms:
Vertigo
Dizziness
Headache
Presbyopia
Ophthalmoplegia
Spasm
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
 Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Refractive Errors
Eye Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Paralysis
Neuromuscular Manifestations

ClinicalTrials.gov processed this record on May 21, 2013