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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
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Group/Cohort
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



Primary Outcome Measures :
  1. objective ocular torsion [ Time Frame: baseline ]
    The angle of objective ocular torsion is measured on a photography of the eye fundus.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SO muscle unilateral paralysis and patients without oculomotor disorder, matched for age.
Criteria

Inclusion Criteria:

For the subjects without oculomotor disorder

  • no diplopia in different positions of gaze;
  • no oculomotor disorder during the orthoptic examination (horizontal phoria <8 prism diopter, vertical phoria <4 prism diopter);
  • corrected visual acuity > 8/10 on both eyes;
  • binocular vision present in Lang I test (defined by 3 elements seen or appointed);
  • orbital MRI: normal oculomotor muscles (including absence of atrophy of the superior oblique muscle) and lack of intra orbital expansive process;
  • brain MRI: no abnormalities in the ways of oculomotor (especially no abnormalities in posterior fossa).

For the patients with SO muscle unilateral paralysis

  • clinical features compatible with unilateral paralysis of the SO muscle
  • muscular body atrophy of the SO on the orbital MRI without other orbital or cerebral abnormality
  • binocular vision in Lang I test

Exclusion Criteria:

  • high refractive error (< -6 diopter or >6 diopter);
  • history or current oculomotor disorder or restrictive neurological disorder (dysthyroid orbitopathy, orbital trauma, retinal detachment surgery, paralysis oculomotor palsy other than IV);
  • optic nerve head abnormalities in the fundus (edema for example)
  • lack of binocular vision Lang I test;
  • pregnant or breastfeeding patient
  • patient under legal protection
  • patient opposition to participate in the study

Information from the National Library of Medicine

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


Contacts
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Contact: Laurence Salomon, MD +33 148 036 431 lsalomon@for.paris

Locations
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France
Fondation Ophtalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Laurence Salomon, M.D.    0033148036431    lsalomon@for.paris   
Principal Investigator: Vincent Toanen, MD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Study Director: François Audren, MD Fondation OPH A de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02894411     History of Changes
Other Study ID Numbers: VTN_2016_18
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
MRI
Excyclotorsion