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Routine Care Study Evaluating Ocular Torsion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02894411
Acronym
EXCYCLOTORSION
Enrollment
172
Registered
2016-09-09
Start date
2016-12-21
Completion date
2019-12-20
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superior Oblique Muscle Palsy

Keywords

MRI, Excyclotorsion

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.

Interventions

None listed

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
objective ocular torsionbaselineThe angle of objective ocular torsion is measured on a photography of the eye fundus.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026