Routine Care Study Evaluating Ocular Torsion (NCT02894411) | Clinical Trial Compass
CompletedNot Applicable
Routine Care Study Evaluating Ocular Torsion
France172 participantsStarted 2016-12-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
objective ocular torsion
Timeframe: baseline
Trial details
NCT IDNCT02894411
SponsorFondation Ophtalmologique Adolphe de Rothschild