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SVorthoptie
Sponsor study identifier
interventional
20
1 country
1
Study Start
February 26, 2018
Actual (reported)Primary Completion
April 30, 2019
Actual (reported)Study Completion
July 13, 2023
Actual (reported)Unilateral vestibular lesions are frequent and disabling pathologies causing a set of oculomotor, postural and perceptual symptoms. These symptoms reduce over time according to a vestibular compensation. However, vestibular compensation should be considered as a set of sub-processes whose duration and recovery level differ. Indeed, after a unilateral vestibular loss, some functions remain asymmetrical as a long-term effect, and these disorders may be observed among patients with no functional complaints. Balance disorders may persist in some patients. The equilibration consists in handling real-time a considerable amount of information coming from the environment and the subject himself, allowing an adaptation of the position and movements of his body to satisfy the needs of posture, balance and orientation. This information comes mainly from the vision, the vestibule and the somesthesic system. It is pre-treated and harmonized in the brainstem, before being transmitted to the higher brain centres. Brain centers thus learn about peripheral conditions. According to these and the project of the movement, brain centers address in response orders to ophtalmological and motor effectors ensuring look, posture and balance to be provided. The eye is a cornerstone of the balancing system through the retina, an environmental sensor, and its extraocular muscles, effectors of the system. The aim of this study is to assess the effects of acute unilateral vestibular loss on visual abilities evaluated by orthoptic balance in patients who presented acute unilateral vestibular loss by surgical deafferentation (removal of vestibular schwannoma, vestibular neurotomy or surgical labyrinthectomy for Meniere's disease), during the early phase and decline of vestibular compensation. Our secondary objective is to evaluate the effect of a pre-existing anomaly of the visual abilities evaluated by orthoptic assessment on the vestibular compensation capacities. All in all, this study seems crucial to improve the management of patients with unilateral vestibular dysfunction and contribute to improving their clinical management. As a standardized management of these patients, an audio-vestibular evaluation will be performed before surgery (-1D), after acute unilateral vestibular loss at the early stage (+7D), and then after vestibular compensation (+2M) as well as an orthoptic evaluation. A good tolerance of the orthoptic evaluation is expected in this surgical context.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 13, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2018
Actual (reported)June 26, 2018
Actual (reported)July 10, 2018
Actual (reported)April 30, 2019
Actual (reported)July 13, 2023
Actual (reported)orthoptic balance
orthoptic assessment
30 minutes
patients with acute unilateral vestibular loss by surgical deafferentation will performed an orthoptic balance
Measurement of visual acuity by far: Monocular measurement, right eye, left eye and binocular Measurement of visual acuity closely: Monocular measurement, right eye, left eye and binocular Corneal reflection method or Hirschberg: Analysis of the corneal reflection after fixation of a point of fixation of light from a distance, then from near. Cover-Test: Study of the restitution movement following the fixation of the fixation point
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Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13005, France
EMILIE GARRIDO PRADALIE
APHM
20 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2018
First Posted
July 10, 2018
Study Start
February 26, 2018
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
April 30, 2019
Actual (reported)Study Completion
July 13, 2023
Actual (reported)Last Updated
July 14, 2023
Record last verified: 2023-07
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Source: ClinicalTrials.gov.
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