Routine Care Study Evaluating Ocular Torsion (EXCYCLOTORSION)

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.

Study Overview

• Status: Completed
• Conditions: Superior Oblique Muscle Palsy

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique A de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with SO muscle unilateral paralysis and patients without oculomotor disorder, matched for age.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective ocular torsion	The angle of objective ocular torsion is measured on a photography of the eye fundus.	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Study Director: François Audren, MD, Fondation OPH A de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2016
• Primary Completion (Actual): October 24, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 5, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: MRI; Excyclotorsion
• Other Study ID Numbers: VTN_2016_18