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

August 26, 2021 updated by: Research Institute of Ophthalmology, Egypt
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Haram
      • Giza, El Haram, Egypt, 12556
        • Research Institute of Ophthalmomogy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: inferior oblique anterior nasal transposition
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
Procedure: inferior oblique weakening
inferior oblique myectomy versus inferior oblique anterior nasal transposition in superior oblique palsy treatment
Active Comparator: inferior oblique myectomy
Group B for inferior oblique myectomy to control vertical deviation but not of large angle which lead to residual inferior oblique overaction
Procedure: inferior oblique weakening
inferior oblique myectomy versus inferior oblique anterior nasal transposition in superior oblique palsy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Ophthalmology, Egypt

Investigators

  • Study Director: Elsayed Mohamed Eltoukhi, prof dr, rio
  • Study Director: Mohammad Othman Abd El Khaleq, Lecturer, Faculty of Medicine, Beni-Suef University
  • Study Director: Sameh Galal Taher, Lecturer, rio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 29, 2021

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03112019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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