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

Primary Purpose

Dissociated Vertical Deviation, Inferior Oblique Overaction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Inferior oblique anteriorization
Inferior oblique anteriorization together with unliateral resction
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dissociated Vertical Deviation focused on measuring DVD, IOOA, IO Anteriorization, IO Anteriorization with rescetion

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Alainy School of Medicine, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1 (Anteriorization group)

Group 2 (Resction group)

Arm Description

Symmetrical Anteriorization of the inferior oblique muscle

Asymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation

Outcomes

Primary Outcome Measures

reduction of the magnitude of DVD
degree of reduction of the deviation measured in prism diopters

Secondary Outcome Measures

reduction of magnitude of IOOA
redctuon in the measured degree of IOOA

Full Information

First Posted
July 31, 2023
Last Updated
July 31, 2023
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05980962
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dissociated Vertical Deviation, Inferior Oblique Overaction
Keywords
DVD, IOOA, IO Anteriorization, IO Anteriorization with rescetion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Anteriorization group)
Arm Type
Active Comparator
Arm Description
Symmetrical Anteriorization of the inferior oblique muscle
Arm Title
Group 2 (Resction group)
Arm Type
Experimental
Arm Description
Asymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation
Intervention Type
Procedure
Intervention Name(s)
Inferior oblique anteriorization
Intervention Description
symmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion
Intervention Type
Procedure
Intervention Name(s)
Inferior oblique anteriorization together with unliateral resction
Intervention Description
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 Outcome Measure Information:
Title
reduction of the magnitude of DVD
Description
degree of reduction of the deviation measured in prism diopters
Time Frame
1 week ,1 month, three months, six months
Secondary Outcome Measure Information:
Title
reduction of magnitude of IOOA
Description
redctuon in the measured degree of IOOA
Time Frame
1 week ,1 month, three months, six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala M. Elhiliali
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Magda S. Abdel-Aziz
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heba M. Fouad
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ghada O. Mohamed
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy School of Medicine, Cairo University
City
Cairo
ZIP/Postal Code
35855
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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