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CompletedNCT05980962Updated Aug 8, 2023

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

An interventional study of Inferior oblique anteriorization and Inferior oblique anteriorization together with unliateral resction in Dissociated Vertical Deviation and Inferior Oblique Overaction, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2023-08-08.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled Dec 2018, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
1 Year and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Dissociated Vertical Deviation
  • Inferior Oblique Overaction

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Keywords

  • DVD
  • IOOA
  • IO Anteriorization
  • IO Anteriorization with rescetion
03

In context

Strabismus

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's enrollment of 54 is close to the median of 60 across 82 interventional studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Group 1 (Anteriorization group)

    Symmetrical Anteriorization of the inferior oblique muscle

    Procedure: Inferior oblique anteriorization

  • 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

Interventions

  • ProcedureInferior oblique anteriorization

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

  • ProcedureInferior 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

06

What researchers measure

Primary outcomes

  1. reduction of the magnitude of DVD

    degree of reduction of the deviation measured in prism diopters

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

Secondary outcomes

  1. reduction of magnitude of IOOA

    redctuon in the measured degree of IOOA

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

07

Study locations

1 site
  • Kasr Alainy School of Medicine, Cairo University
    Cairo, 35855, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05980962
Responsible party
Ghada Osama Mohamed (Dr., Kasr El Aini Hospital) — Principal investigator
First posted
Aug 8, 2023
Start date
Dec 1, 2018
Primary completion
Dec 31, 2021
Completion
Jul 15, 2022
Last update
Aug 8, 2023

Study contacts

Hala M. Elhiliali
study chair · Cairo University
Magda S. Abdel-Aziz
study director · Cairo University
Heba M. Fouad
study director · Cairo University
Ghada O. Mohamed
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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