Routine Care Study Evaluating Ocular Torsion

Superior Oblique Muscle Palsy Clinical Trial

— EXCYCLOTORSION  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894411
• Other study ID #: VTN_2016_18
• Status: Completed
• Start date: December 21, 2016
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: December 20, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Superior Oblique Muscle Palsy

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective ocular torsion	The angle of objective ocular torsion is measured on a photography of the eye fundus.	baseline