Routine Care Study Evaluating Ocular Torsion (EXCYCLOTORSION)
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|ClinicalTrials.gov Identifier: NCT02894411|
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : January 16, 2019
The paralysis of the fourth cranial nerve (paralysis IV), commonly known as the superior oblique muscle (SO) paralysis, represents half of vertical strabismus. The diagnosis of SO paralysis and of its congenital or acquired etiology, are based on a range of clinical findings. The three main clinical diagnostic elements are the hypertropia in paralyzed side which increases in adducted position, the positivity of Bielschowsky head tilt test and the twisting of the eye fundus. These criteria are always considered together and are interdependent. The diagnostic value and the sensitivity of each of these signs is not defined. Brain and orbital Magnetic Resonance Imaging (MRI) allowed a better understanding of the physiopathology of a number of oculomotor disorders.
For this reason, MRI constitute a reference for the SO palsy. The atrophy of the SO muscle is qualitatively determined by the asymmetry of muscle volume on two contiguous coronal MRI.
The diagnostic value of various clinical signs observed in SO paralysis (sensitivity, specificity) remains unknown.
|Condition or disease|
|Superior Oblique Muscle Palsy|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Actual Study Start Date :||December 21, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
No ocular motility disorders
Patients without ocular motility disorders, with normal orbital and brain MRI.
superior oblique muscle palsy
Clinical features compatible with unilateral paralysis of the SO muscle Atrophy of the SO muscle on the orbital MRI without other orbital or cerebral anomaly
- objective ocular torsion [ Time Frame: baseline ]The angle of objective ocular torsion is measured on a photography of the eye fundus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894411
|Contact: Laurence Salomon, MD||+33 148 036 firstname.lastname@example.org|
|Fondation Ophtalmologique A de Rothschild||Recruiting|
|Paris, France, 75019|
|Contact: Laurence Salomon, M.D. 0033148036431 email@example.com|
|Principal Investigator: Vincent Toanen, MD|
|Study Director:||François Audren, MD||Fondation OPH A de Rothschild|