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

NCT05031312 | Completed

• 1 other identifier: 03112019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Superior Oblique Palsy

Keywords

myectomy; superior oblique palsy; inferior oblique overaction; anterior nasal transposition

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Study Arms (2)

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

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

Procedure: inferior oblique weakening

Interventions

inferior oblique weakening PROCEDURE

inferior oblique myectomy versus inferior oblique anterior nasal transposition in superior oblique palsy treatment

inferior oblique anterior nasal transposition; inferior oblique myectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The following patients will be excluded:
• Patients with previous cyclo-vertical muscle surgeries.
• Connective tissue diseases.
• Previous orbital surgery.

Sponsors & Collaborators

• Research Institute of Ophthalmology, Egypt: lead

Study Sites (1)

Research Institute of Ophthalmomogy

Giza, El Haram, 12556, Egypt

Location

Related Publications (9)

• 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.

  PMID: 26486020 BACKGROUND

• 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.

  PMID: 29178265 BACKGROUND

• 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.

  PMID: 24030536 BACKGROUND

• 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.

  PMID: 24893352 BACKGROUND

• 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.

  PMID: 30522394 BACKGROUND

• 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.

  PMID: 23203704 BACKGROUND

• 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.

  PMID: 14704751 BACKGROUND

• 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.

  PMID: 28713055 BACKGROUND

• 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.

  PMID: 31396413 BACKGROUND

MeSH Terms

Conditions

Trochlear Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 .

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 1, 2021
• Study Start: November 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: July 29, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)