Superior Oblique PalsyNCT05031312
Inferior Oblique Myectomy Versus Anterior and Nasal Transposition of Its Tendon for Treatment of Superior Oblique Muscle Palsy
A study testing inferior oblique weakening in people with Superior Oblique Palsy, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
Trial summary
This Study aims at comparing the safety and efficacy of inferior oblique myectomy to anterior and nasal transposition of inferior oblique as two treatment options of superior oblique palsy regarding ocular alignment , alphabetical pattern correction , comitance and limitation of ocular motility Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superior Oblique Palsy
- What is being tested?
- inferior oblique weakening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 29 Jul 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with superior oblique palsy (unilateral or bilateral) with no age restriction from males and females cases .
Who cannot join
- -
- The following patients will be excluded:
- Patients with previous cyclo-vertical muscle surgeries.
- Connective tissue diseases.
- Previous orbital surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This Study aims at comparing the safety and efficacy of inferior oblique myectomy to anterior and nasal transposition of inferior oblique as two treatment options of superior oblique palsy regarding ocular alignment , alphabetical pattern correction , comitance and limitation of ocular motility
Read the detailed description
Superior oblique palsy is one of the most common causes of vertical ocular muscle palsy. It may be congenital or acquired with over-elevation of the affected eye in primary position that increases in contralateral gaze and with ipsilateral head tilt . Torsional and vertical diplopia may occur resulting in compensatory head tilt .
Bilateral superior oblique palsy is approximately 29%-38% of cases of superior oblique palsy. It is a rare congenital or acquired ocular motility disorder. It can be symmetrical or asymmetrical .
Superior oblique palsy can be treated by different types of surgeries including superior oblique strengthening by tucking of its tendon, contralateral inferior rectus muscle recession, recession of ipsilateral superior rectus muscle or inferior oblique weakening by disinsertion , myectomy , recession and anterior transposition .
Superior oblique tucking is an efficient and safe procedure for treatment of superior oblique palsy with vertical deviation less than 15 prism diopter in the primary position and remarkable superior oblique under action. The superior oblique forced duction test is the most important for planning surgery .This procedure may cause iatrogenic post-operative Brown syndrome .
Recession of the ipsilateral superior rectus muscle reduces the upward force elevating the hypertropic eye. Recession of the contralateral inferior rectus muscle is another option that reduces the force shifting the contralateral eye downward to match the position of the other hypertropic eye due to superior oblique muscle palsy .
Inferior oblique disinsertion is one of inferior oblique muscle weakening procedures with high efficacy when used simultaneously with superior rectus recession to control large vertical deviations in superior oblique palsy with contracture of superior rectus muscle . This may carry a high risk of postoperative overcorrection .
Inferior oblique recession is effective in weakening of its action and treatment of superior oblique palsy. Inferior oblique myectomy is more effective than recession in improving hyper-elevation in primary gaze specially in those patients with small to moderate preoperative hyperopia .
Inferior oblique myectomy temporal to the inferior rectus muscle is the most popular procedure to treat inferior oblique over action and reduce vertical deviation .
Inferior oblique anterior transposition was first described at (1980) to correct both excyclotorsion and hypertropia in superior oblique palsy presenting with inferior oblique over action but this may be complicated by post-operative limited elevation . At 1992 -2001 antero-nasal transposition of inferior oblique was described to overcome these problems by converting inferior oblique muscle from an elevator and extorted muscle to depressor in adduction and intorted muscle . This makes it one of the surgical options for inferior oblique weakening in superior oblique palsy with reduction of antielevation complications associated with anterior inferior oblique transposition .
The retrospective studies were done between 2012-2017 and for 6 months postoperative follow up that have reported postoperative inferior oblique over action rates of 1.7%- 5% following myectomy, 4% residual inferior oblique overaction was detected in recession in contrast to only 2% residual over action in the eyes that had inferior oblique anterior transposition with only 4% antielevation syndrome developed but with orthotropia in the primary position and no further surgery was performed .
- Conditions
- Superior Oblique Palsy
- Being tested
- inferior oblique weakening
- Keywords
- myectomy, superior oblique palsy, inferior oblique overaction, anterior nasal transposition
- Medical subject headings
- Trochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior oblique weakeningProcedure or surgery
inferior oblique myectomy versus inferior oblique anterior nasal transposition in superior oblique palsy treatment
| Study group | Role | What they receive |
|---|---|---|
| inferior oblique anterior nasal transposition | Active comparator | Group A for inferior oblique anterior nasal transposition 2mmx2mm posterior and nasal to inferior rectus insertion to control vertical deviation especially large angle vertical deviation and V pattern with more potent postoperative effect in unilateral and bilateral cases Receives: Procedure: inferior oblique weakening |
| inferior oblique myectomy | Active comparator | Group B for inferior oblique myectomy to control vertical deviation but not of large angle which lead to residual inferior oblique overaction Receives: Procedure: inferior oblique weakening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior oblique Myectomy versus Anterior and Nasal transposition of its tendon for treatment of Superior oblique muscle palsy
30 participants ,15 participants of them were included in anterior nasal transposition ,15 participants were included in myectomy group with assessment of pre and postoperative vertical deviation with prism diopter , V pattern with prism diopter , torsion with degree , palpebral fissure with millimeter and grading over or underaction of inferior oblique by numbers from1 to 4
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Nov 2019
- Primary completion30 Jun 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Superior Oblique 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective comparative simple randomized study of 30 cases of superior oblique palsy divided in to two groups (A) and (B) Group A will include 15 cases who will undergo inferior oblique anterior and nasal transposition and group B will include 15 cases who will undergo inferior oblique myectomy .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsayed Mohamed Eltoukhi, prof dr, Study director, rioMohammad Othman Abd El Khaleq, Lecturer, Study director, Faculty of Medicine, Beni-suef UniversitySameh Galal Taher, Lecturer, Study director, rio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031312
- Sponsor's protocol ID
- 03112019
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clifford L, Roos J, Dahlmann-Noor A, Vivian AJ. Surgical management of superior oblique paresis using inferior oblique anterior transposition. J AAPOS. 2015 Oct;19(5):406-9. doi: 10.1016/j.jaapos.2015.07.280.
PubMed 26486020Chang MY, Coleman AL, Tseng VL, Demer JL. Surgical interventions for vertical strabismus in superior oblique palsy. Cochrane Database Syst Rev. 2017 Nov 27;11(11):CD012447. doi: 10.1002/14651858.CD012447.pub2.
PubMed 29178265Merino PS, Rojas PL, Gomez De Liano PS, Fukumitsu HM, Yanez JM. Bilateral superior oblique palsy: etiology and therapeutic options. Eur J Ophthalmol. 2014 Mar-Apr;24(2):147-52. doi: 10.5301/ejo.5000362. Epub 2013 Sep 5.
PubMed 24030536Li Y, Zhao K. Superior oblique tucking for treatment of superior oblique palsy. J Pediatr Ophthalmol Strabismus. 2014 Jul 1;51(4):249-54. doi: 10.3928/01913913-20140527-01. Epub 2014 Jun 3.
PubMed 24893352Ozkan SB, Akyuz Unsal AI, Kagnici DB. The efficacy of superior rectus recession with simultaneous inferior oblique disinsertion on superior oblique palsy with superior rectus contracture. Strabismus. 2019 Mar;27(1):16-23. doi: 10.1080/09273972.2018.1553986. Epub 2018 Dec 7.
PubMed 30522394Bahl RS, Marcotty A, Rychwalski PJ, Traboulsi EI. Comparison of inferior oblique myectomy to recession for the treatment of superior oblique palsy. Br J Ophthalmol. 2013 Feb;97(2):184-8. doi: 10.1136/bjophthalmol-2012-301485. Epub 2012 Nov 30.
PubMed 23203704Shipman T, Burke J. Unilateral inferior oblique muscle myectomy and recession in the treatment of inferior oblique muscle overaction: a longitudinal study. Eye (Lond). 2003 Nov;17(9):1013-8. doi: 10.1038/sj.eye.6700488.
PubMed 14704751Saxena R, Sharma M, Singh D, Sharma P. Anterior and nasal transposition of inferior oblique muscle in cases of superior oblique palsy. J AAPOS. 2017 Aug;21(4):282-285. doi: 10.1016/j.jaapos.2017.05.026. Epub 2017 Jul 14.
PubMed 28713055Ozsoy E, Gunduz A, Ozturk E. Inferior Oblique Muscle Overaction: Clinical Features and Surgical Management. J Ophthalmol. 2019 Jul 17;2019:9713189. doi: 10.1155/2019/9713189. eCollection 2019.
PubMed 31396413
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Oblique Myectomy Versus Anterior and Nasal Transposition of Its Tendon for Treatment of Superior Oblique Muscle Palsy
- ClinicalTrials.gov ID
- NCT05031312
- Acronym / sponsor ID
- 03112019
- Conditions
- Superior Oblique Palsy
- Keywords
- myectomy, superior oblique palsy, inferior oblique overaction, anterior nasal transposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 1 Sep 2021 (actual)
- 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.
This Study aims at comparing the safety and efficacy of inferior oblique myectomy to anterior and nasal transposition of inferior oblique as two treatment options of superior oblique palsy regarding ocular alignment , alphabetical pattern correction , comitance and limitation of ocular motility
Detailed description
Superior oblique palsy is one of the most common causes of vertical ocular muscle palsy. It may be congenital or acquired with over-elevation of the affected eye in primary position that increases in contralateral gaze and with ipsilateral head tilt . Torsional and vertical diplopia may occur resulting in compensatory head tilt .
Bilateral superior oblique palsy is approximately 29%-38% of cases of superior oblique palsy. It is a rare congenital or acquired ocular motility disorder. It can be symmetrical or asymmetrical .
Superior oblique palsy can be treated by different types of surgeries including superior oblique strengthening by tucking of its tendon, contralateral inferior rectus muscle recession, recession of ipsilateral superior rectus muscle or inferior oblique weakening by disinsertion , myectomy , recession and anterior transposition .
Superior oblique tucking is an efficient and safe procedure for treatment of superior oblique palsy with vertical deviation less than 15 prism diopter in the primary position and remarkable superior oblique under action. The superior oblique forced duction test is the most important for planning surgery .This procedure may cause iatrogenic post-operative Brown syndrome .
Recession of the ipsilateral superior rectus muscle reduces the upward force elevating the hypertropic eye. Recession of the contralateral inferior rectus muscle is another option that reduces the force shifting the contralateral eye downward to match the position of the other hypertropic eye due to superior oblique muscle palsy .
Inferior oblique disinsertion is one of inferior oblique muscle weakening procedures with high efficacy when used simultaneously with superior rectus recession to control large vertical deviations in superior oblique palsy with contracture of superior rectus muscle . This may carry a high risk of postoperative overcorrection .
Inferior oblique recession is effective in weakening of its action and treatment of superior oblique palsy. Inferior oblique myectomy is more effective than recession in improving hyper-elevation in primary gaze specially in those patients with small to moderate preoperative hyperopia .
Inferior oblique myectomy temporal to the inferior rectus muscle is the most popular procedure to treat inferior oblique over action and reduce vertical deviation .
Inferior oblique anterior transposition was first described at (1980) to correct both excyclotorsion and hypertropia in superior oblique palsy presenting with inferior oblique over action but this may be complicated by post-operative limited elevation . At 1992 -2001 antero-nasal transposition of inferior oblique was described to overcome these problems by converting inferior oblique muscle from an elevator and extorted muscle to depressor in adduction and intorted muscle . This makes it one of the surgical options for inferior oblique weakening in superior oblique palsy with reduction of antielevation complications associated with anterior inferior oblique transposition .
The retrospective studies were done between 2012-2017 and for 6 months postoperative follow up that have reported postoperative inferior oblique over action rates of 1.7%- 5% following myectomy, 4% residual inferior oblique overaction was detected in recession in contrast to only 2% residual over action in the eyes that had inferior oblique anterior transposition with only 4% antielevation syndrome developed but with orthotropia in the primary position and no further surgery was performed .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective comparative simple randomized study of 30 cases of superior oblique palsy divided in to two groups (A) and (B) Group A will include 15 cases who will undergo inferior oblique anterior and nasal transposition and group B will include 15 cases who will undergo inferior oblique myectomy .
| Arm | Type | Receives |
|---|---|---|
| inferior oblique anterior nasal transposition | Active comparator | Procedure: inferior oblique weakeningGroup A for inferior oblique anterior nasal transposition 2mmx2mm posterior and nasal to inferior rectus insertion to control vertical deviation especially large angle vertical deviation and V pattern with more potent postoperative effect in unilateral and bilateral cases |
| inferior oblique myectomy | Active comparator | Procedure: inferior oblique weakeningGroup B for inferior oblique myectomy to control vertical deviation but not of large angle which lead to residual inferior oblique overaction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with superior oblique palsy (unilateral or bilateral) with no age restriction from males and females cases .
Key exclusion criteria (5 listed)
- -
- Patients with previous cyclo-vertical muscle surgeries.
- Connective tissue diseases.
- Previous orbital surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inferior oblique weakeninginferior oblique myectomy versus inferior oblique anterior nasal transposition in superior oblique palsy treatment | Procedure or surgery | inferior oblique anterior nasal transposition, inferior oblique myectomy |
Primary outcome
Inferior oblique Myectomy versus Anterior and Nasal transposition of its tendon for treatment of Superior oblique muscle palsy
Time frame: Baseline
30 participants ,15 participants of them were included in anterior nasal transposition ,15 participants were included in myectomy group with assessment of pre and postoperative vertical deviation with prism diopter , V pattern with prism diopter , torsion with degree , palpebral fissure with millimeter and grading over or underaction of inferior oblique by numbers from1 to 4
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 1 Sep 2021.
- Background: PubMed 26486020Clifford L, Roos J, Dahlmann-Noor A, Vivian AJ. Surgical management of superior oblique paresis using inferior oblique anterior transposition. J AAPOS. 2015 Oct;19(5):406-9. doi: 10.1016/j.jaapos.2015.07.280.
- Background: PubMed 29178265Chang MY, Coleman AL, Tseng VL, Demer JL. Surgical interventions for vertical strabismus in superior oblique palsy. Cochrane Database Syst Rev. 2017 Nov 27;11(11):CD012447. doi: 10.1002/14651858.CD012447.pub2.
- Background: PubMed 24030536Merino PS, Rojas PL, Gomez De Liano PS, Fukumitsu HM, Yanez JM. Bilateral superior oblique palsy: etiology and therapeutic options. Eur J Ophthalmol. 2014 Mar-Apr;24(2):147-52. doi: 10.5301/ejo.5000362. Epub 2013 Sep 5.
- Background: PubMed 24893352Li Y, Zhao K. Superior oblique tucking for treatment of superior oblique palsy. J Pediatr Ophthalmol Strabismus. 2014 Jul 1;51(4):249-54. doi: 10.3928/01913913-20140527-01. Epub 2014 Jun 3.
- Background: PubMed 30522394Ozkan SB, Akyuz Unsal AI, Kagnici DB. The efficacy of superior rectus recession with simultaneous inferior oblique disinsertion on superior oblique palsy with superior rectus contracture. Strabismus. 2019 Mar;27(1):16-23. doi: 10.1080/09273972.2018.1553986. Epub 2018 Dec 7.
- Background: PubMed 23203704Bahl RS, Marcotty A, Rychwalski PJ, Traboulsi EI. Comparison of inferior oblique myectomy to recession for the treatment of superior oblique palsy. Br J Ophthalmol. 2013 Feb;97(2):184-8. doi: 10.1136/bjophthalmol-2012-301485. Epub 2012 Nov 30.
- Background: PubMed 14704751Shipman T, Burke J. Unilateral inferior oblique muscle myectomy and recession in the treatment of inferior oblique muscle overaction: a longitudinal study. Eye (Lond). 2003 Nov;17(9):1013-8. doi: 10.1038/sj.eye.6700488.
- Background: PubMed 28713055Saxena R, Sharma M, Singh D, Sharma P. Anterior and nasal transposition of inferior oblique muscle in cases of superior oblique palsy. J AAPOS. 2017 Aug;21(4):282-285. doi: 10.1016/j.jaapos.2017.05.026. Epub 2017 Jul 14.
- Background: PubMed 31396413Ozsoy E, Gunduz A, Ozturk E. Inferior Oblique Muscle Overaction: Clinical Features and Surgical Management. J Ophthalmol. 2019 Jul 17;2019:9713189. doi: 10.1155/2019/9713189. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Superior Oblique Palsy
RecruitingObservational study
Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies
Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
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.
Elsayed Mohamed Eltoukhi, prof dr study director
rio
Mohammad Othman Abd El Khaleq, Lecturer study director
Faculty of Medicine, Beni-suef University
Sameh Galal Taher, Lecturer study director
rio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inferior oblique weakening in people with Superior Oblique Palsy, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
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 1 inclusion and 5 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 1 Sep 2021. 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 Egypt. 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?
Inferior oblique Myectomy versus Anterior and Nasal transposition of its tendon for treatment of Superior oblique muscle palsy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031312, which also lists 9 linked publications.
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 1 Sep 2021.