Superior Rectus PalsyEXCYCLONCT02900885
Study of Ocular Torsion in Patients Suffering From Palsy of the Superior Rectus Extraocular Muscle
An observational study of Superior Rectus Palsy, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Retrospective medical chart and medical imaging file review of patients suffering from palsy of the superior rectus extraocular muscle Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superior Rectus Palsy
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2015
- 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: Patiente suffering from unilateral muscular palsy of the superior rectus extraocular muscle
Who may be able to join
- Patient with unilateral muscular palsy of the superior rectus muscle
- Patient must have a binocular vision as characterized by Lang test
Who cannot join
- bilateral impairment of the superior rectus muscle
- presence of an orbital lesion (orbital trauma, tumor or pseudo-tumor)
- thyroid orbitopathy
- No binovular vision
About this study
Retrospective medical chart and medical imaging file review of patients suffering from palsy of the superior rectus extraocular muscle
- Conditions
- Superior Rectus Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Excyclotorsion of the eye as measured in angle degrees by retinophotography
Measured: Within 1 week prior to corrective surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2012
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Rectus PalsyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900885
- Sponsor's protocol ID
- NI_VTN_2015_1
- Acronym
- EXCYCLO
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ocular Torsion in Patients Suffering From Palsy of the Superior Rectus Extraocular Muscle
- ClinicalTrials.gov ID
- NCT02900885
- Acronym / sponsor ID
- EXCYCLO / NI_VTN_2015_1
- Conditions
- Superior Rectus Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- First posted
- 14 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.
Retrospective medical chart and medical imaging file review of patients suffering from palsy of the superior rectus extraocular muscle
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patiente suffering from unilateral muscular palsy of the superior rectus extraocular muscle
Key inclusion criteria (2 listed)
- Patient with unilateral muscular palsy of the superior rectus muscle
- Patient must have a binocular vision as characterized by Lang test
Key exclusion criteria (4 listed)
- bilateral impairment of the superior rectus muscle
- presence of an orbital lesion (orbital trauma, tumor or pseudo-tumor)
- thyroid orbitopathy
- No binovular vision
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
Excyclotorsion of the eye as measured in angle degrees by retinophotography
Time frame: Within 1 week prior to corrective surgery
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 14 Sep 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Superior Rectus Palsy, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 2 inclusion and 4 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Excyclotorsion of the eye as measured in angle degrees by retinophotography (time frame: Within 1 week prior to corrective surgery). 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 14 Sep 2016.