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

NCT05980962 | Completed DMC

• 1 other identifier: N-97-2018
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Dissociated Vertical Deviation; Inferior Oblique Overaction

Keywords

DVD; IOOA; IO Anteriorization; IO Anteriorization with rescetion

Outcome Measures

Primary Outcomes (1)

• reduction of the magnitude of DVD

  degree of reduction of the deviation measured in prism diopters

  1 week ,1 month, three months, six months

Secondary Outcomes (1)

• reduction of magnitude of IOOA

  1 week ,1 month, three months, six months

Study Arms (2)

Group 1 (Anteriorization group)

ACTIVE COMPARATOR

Symmetrical Anteriorization of the inferior oblique muscle

Procedure: Inferior oblique anteriorization

Group 2 (Resction group)

EXPERIMENTAL

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

Inferior oblique anteriorization PROCEDURE

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

Group 1 (Anteriorization group)

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

Group 2 (Resction group)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Manifest DVD decompensated to a tropia with free ocular motility
• Cases with or without horizontal misalignment
• Cases with or without previous horizontal muscle surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy School of Medicine, Cairo University

Cairo, 35855, Egypt

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Hala M. Elhiliali

  Cairo University

  STUDY CHAIR

• Magda S. Abdel-Aziz

  Cairo University

  STUDY DIRECTOR

• Heba M. Fouad

  Cairo University

  STUDY DIRECTOR

• Ghada O. Mohamed

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: December 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: July 15, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)