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NCT Number: NCT05980962

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

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.

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Key information

Conditions

Dissociated Vertical Deviation Cranial Nerve Diseases Eye Diseases Inferior Oblique Overaction Nervous System Diseases Ocular Motility Disorders Strabismus

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy School of Medicine, Cairo University

Cairo, 35855, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inferior oblique anteriorization

Procedure

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

Inferior oblique anteriorization together with unliateral resction

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

Primary outcomes

  1. reduction of the magnitude of DVD

    Time frame: 1 week ,1 month, three months, six months

    degree of reduction of the deviation measured in prism diopters

Secondary outcomes

  1. reduction of magnitude of IOOA

    Time frame: 1 week ,1 month, three months, six months

    redctuon in the measured degree of IOOA

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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