Inferior Oblique Muscle Anteriorization Versus Anteriorization and Resection in DVD With IOOA

Anteriorization of the Inferior Oblique Muscle Versus Anteriorization and Resection for Asymmetrical Dissociated Vertical Deviation With Inferior Oblique Muscle Overaction

The goal of this clinical trial is to compare the results of two surgical modalities in patients with Dissociated vertical deviation with inferior oblique muscle overaction . The main questions it aims to answer are:

• How much does the magnitude of DVD improve after each modality?
• Is the IOOA eliminated? Participants will be divided into two equal groups; Researchers will compare the efficacy of symmetrical anteriorization of the inferior oblique and adding an additional rescetion to one eye in the second group to see which group had more signifcant reduction in the magnitude of DVD and IOOA.

Study Overview

• Status: Completed
• Conditions: Inferior Oblique Overaction; Dissociated Vertical Deviation
• Intervention / Treatment: Procedure: Inferior oblique anteriorization; Procedure: Inferior oblique anteriorization together with unliateral resction

Detailed Description

A prospective study was performed on patients with bilateral symmterical dissociated vertical deviation(DVD) and bilateral inferior oblique muscle overaction (IOOA) in Cairo University hospitals starting from February 2018 through December 2021. Patients wetre included in the study if they had a minimum follow up period of 6 months. The study included 54 patients (108 eyes) with manifest DVD and IOOA in boths eyes. Patients were divided into two equal groups. The paitents in group 1 underwent symmetrical inferior oblique muscle anteriorization, while the patients in group 2 underwent ayymmetrical surgery , where inferior oblique anteriorization was performed in one eye the same manner is in group 1, and the eye with the larger deviation had an additional 3-5 mm rescetion of the inferior oblique muscle along with anteriorization according to the measured DVD difference between both eyes, whether less than or more than 5 prism diopters respectively.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 35855
    • Kasr Alainy School of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Manifest DVD decompensated to a tropia with free ocular motility
• Cases with or without horizontal misalignment
• Cases with or without previous horizontal muscle surgery

Exclusion Criteria:

• Incomitant, Paralytic or restrictive strabismus
• Eyes with previous inferior oblique muscle surgery
• Recurrent DVD after surgical treatment
• Eyes with previous scleral buckling for retinal deatchment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (Anteriorization group); Symmetrical Anteriorization of the inferior oblique muscle	Procedure: Inferior oblique anteriorization; symmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion
Experimental: Group 2 (Resction group); Asymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation	Procedure: Inferior oblique anteriorization together with unliateral resction; asymmterical surgery, anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion in one eye, and an additional 3-5 mm resction of the inferior oblique in the eye with the larger devation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of the magnitude of DVD	degree of reduction of the deviation measured in prism diopters	1 week ,1 month, three months, six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of magnitude of IOOA	redctuon in the measured degree of IOOA	1 week ,1 month, three months, six months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Chair: Hala M. Elhiliali, Cairo University; Study Director: Magda S. Abdel-Aziz, Cairo University; Study Director: Heba M. Fouad, Cairo University; Principal Investigator: Ghada O. Mohamed, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: DVD; IOOA; IO Anteriorization; IO Anteriorization with rescetion
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus
• Other Study ID Numbers: N-97-2018

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