Clinical trial NCT05980962: Inferior Oblique Muscle Anteriorization Versus Anteriorization and Resection in DVD With IOOA
Official title: Anteriorization of the Inferior Oblique Muscle Versus Anteriorization and Resection for Asymmetrical Dissociated Vertical Deviation With Inferior Oblique Muscle Overaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dissociated Vertical Deviation
Inferior Oblique Overaction
Keywords: DVD
IOOA
IO Anteriorization
IO Anteriorization with rescetion
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: reduction of the magnitude of DVD
timeFrame: 1 week ,1 month, three months, six months
Secondary outcomes:
measure: reduction of magnitude of IOOA
timeFrame: 1 week ,1 month, three months, six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy School of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Hala M. Elhiliali
role: STUDY_CHAIR
affiliation: Cairo University
name: Magda S. Abdel-Aziz
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Heba M. Fouad
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ghada O. Mohamed
role: PRINCIPAL_INVESTIGATOR
References: