Clinical trial NCT05031312: Inferior Oblique Myectomy Versus Anterior and Nasal Transposition of Its Tendon for Treatment of Superior Oblique Muscle Palsy
Official title: Inferior Oblique Myectomy Versus Anterior and Nasal Transposition of Its Tendon for Treatment of Superior Oblique Muscle Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superior Oblique Palsy
Keywords: myectomy
superior oblique palsy
inferior oblique overaction
anterior nasal transposition
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 .
Primary purpose: TREATMENT

Brief 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

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 .

Eligibility criteria: Inclusion Criteria:

* Patients with superior oblique palsy (unilateral or bilateral) with no age restriction from males and females cases .

Exclusion Criteria:

-

The following patients will be excluded:

1. Patients with previous cyclo-vertical muscle surgeries.
2. Connective tissue diseases.
3. Previous orbital surgery.

Primary outcomes:
measure: Inferior oblique Myectomy versus Anterior and Nasal transposition of its tendon for treatment of Superior oblique muscle palsy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthalmomogy
state: El Haram
Study officials:
affiliation: rio
name: Elsayed Mohamed Eltoukhi, prof dr
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Beni-suef University
name: Mohammad Othman Abd El Khaleq, Lecturer
role: STUDY_DIRECTOR
affiliation: rio
name: Sameh Galal Taher, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Chang 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.
citation: Merino 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.
citation: Li 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.
citation: Ozkan 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.
citation: Bahl 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.
citation: Shipman 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.
citation: Saxena 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.
citation: Ozsoy 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.