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

Not Applicable

Completed

• Conditions: Dissociated Vertical Deviation; Inferior Oblique Overaction
• Interventions: Procedure: Inferior oblique anteriorization; Procedure: Inferior oblique anteriorization together with unliateral resction

• Registration Number: NCT05980962
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2018-12-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-15
• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Anteriorization group)	Inferior oblique anteriorization	Symmetrical Anteriorization of the inferior oblique muscle
Group 2 (Resction group)	Inferior oblique anteriorization together with unliateral resction	Asymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation

Primary Outcome Measures

Name	Time	Method
reduction of the magnitude of DVD	1 week ,1 month, three months, six months	degree of reduction of the deviation measured in prism diopters

Secondary Outcome Measures

Name	Time	Method
reduction of magnitude of IOOA	1 week ,1 month, three months, six months	redctuon in the measured degree of IOOA

Trial Locations

Locations (1)

Kasr Alainy School of Medicine, Cairo University; 🇪🇬 Cairo, Egypt