search
Back to results

Inferior Oblique Myectomy Versus Anterior and Nasal Transposition of Its Tendon for Treatment of Superior Oblique Muscle Palsy

Primary Purpose

Superior Oblique Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
inferior oblique weakening
Sponsored by
Research Institute of Ophthalmology, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superior Oblique Palsy focused on measuring myectomy, superior oblique palsy, inferior oblique overaction, anterior nasal transposition

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Institute of Ophthalmomogy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

inferior oblique anterior nasal transposition

inferior oblique myectomy

Arm Description

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

Group B for inferior oblique myectomy to control vertical deviation but not of large angle which lead to residual inferior oblique overaction

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2021
Last Updated
August 26, 2021
Sponsor
Research Institute of Ophthalmology, Egypt
search

1. Study Identification

Unique Protocol Identification Number
NCT05031312
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Institute of Ophthalmology, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superior Oblique Palsy
Keywords
myectomy, superior oblique palsy, inferior oblique overaction, anterior nasal transposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inferior oblique anterior nasal transposition
Arm Type
Active Comparator
Arm Description
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
Arm Title
inferior oblique myectomy
Arm Type
Active Comparator
Arm Description
Group B for inferior oblique myectomy to control vertical deviation but not of large angle which lead to residual inferior oblique overaction
Intervention Type
Procedure
Intervention Name(s)
inferior oblique weakening
Intervention Description
inferior oblique myectomy versus inferior oblique anterior nasal transposition in superior oblique palsy treatment
Primary Outcome Measure Information:
Title
Inferior oblique Myectomy versus Anterior and Nasal transposition of its tendon for treatment of Superior oblique muscle palsy
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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: Patients with previous cyclo-vertical muscle surgeries. Connective tissue diseases. Previous orbital surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elsayed Mohamed Eltoukhi, prof dr
Organizational Affiliation
rio
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Othman Abd El Khaleq, Lecturer
Organizational Affiliation
Faculty of Medicine, Beni-suef University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sameh Galal Taher, Lecturer
Organizational Affiliation
rio
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Ophthalmomogy
City
Giza
State/Province
El Haram
ZIP/Postal Code
12556
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26486020
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.
Results Reference
background
PubMed Identifier
29178265
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.
Results Reference
background
PubMed Identifier
24030536
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.
Results Reference
background
PubMed Identifier
24893352
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.
Results Reference
background
PubMed Identifier
30522394
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.
Results Reference
background
PubMed Identifier
23203704
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.
Results Reference
background
PubMed Identifier
14704751
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.
Results Reference
background
PubMed Identifier
28713055
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.
Results Reference
background
PubMed Identifier
31396413
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.
Results Reference
background

Learn more about this trial

Inferior Oblique Myectomy Versus Anterior and Nasal Transposition of Its Tendon for Treatment of Superior Oblique Muscle Palsy

We'll reach out to this number within 24 hrs