Superior Oblique Muscle PalsyEXCYCLOTORSIONNCT02894411
Routine Care Study Evaluating Ocular Torsion
An observational study of Superior Oblique Muscle Palsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superior Oblique Muscle Palsy
- How many people
- 172 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2016to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with SO muscle unilateral paralysis and patients without oculomotor disorder, matched for age.
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Superior Oblique Muscle Palsy
- Keywords
- MRI, Excyclotorsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
objective ocular torsion
The angle of objective ocular torsion is measured on a photography of the eye fundus.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start21 Dec 2016
- Primary completion24 Oct 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Oblique Muscle PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- François Audren, MD, Study director, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894411
- Sponsor's protocol ID
- VTN_2016_18
- Acronym
- EXCYCLOTORSION
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Care Study Evaluating Ocular Torsion
- ClinicalTrials.gov ID
- NCT02894411
- Acronym / sponsor ID
- EXCYCLOTORSION / VTN_2016_18
- Conditions
- Superior Oblique Muscle Palsy
- Keywords
- MRI, Excyclotorsion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SO muscle unilateral paralysis and patients without oculomotor disorder, matched for age.
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
objective ocular torsion
Time frame: baseline
The angle of objective ocular torsion is measured on a photography of the eye fundus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Audren, MD study director
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superior Oblique Muscle Palsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective ocular torsion (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.