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

NCT ID: NCT05980962

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-07-15

Brief Summary

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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

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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.

Conditions

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Dissociated Vertical Deviation Inferior Oblique Overaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group 1 (Anteriorization group)

Symmetrical Anteriorization of the inferior oblique muscle

Group Type ACTIVE_COMPARATOR

Inferior oblique anteriorization

Intervention Type PROCEDURE

symmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion

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

Group Type EXPERIMENTAL

Inferior oblique anteriorization together with unliateral resction

Intervention Type PROCEDURE

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

Interventions

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Inferior oblique anteriorization

symmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ghada Osama Mohamed

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala M. Elhiliali

Role: STUDY_CHAIR

Cairo University

Magda S. Abdel-Aziz

Role: STUDY_DIRECTOR

Cairo University

Heba M. Fouad

Role: STUDY_DIRECTOR

Cairo University

Ghada O. Mohamed

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr Alainy School of Medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-97-2018

Identifier Type: -

Identifier Source: org_study_id

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