Correction of V-pattern Strabismus by Graded Recession of Inferior Oblique Muscle . (Pattern)

Evaluation of Graded Recession of Inferior Oblique Muscle for Correction of Different Grades of V-pattern Strabismus

V pattern strabismus is the commonest of alphabet pattern. Its identification is essential to plan a proper surgical management. Graded recession is a very logical approach to treat inferior oblique overaction (IOOA). The aim Is to evaluate the efficacy of graded recession of inferior oblique muscle for correction of different grades of V pattern.

Study Overview

• Status: Completed
• Conditions: V Pattern Esotropia; Monocular Exotropia With V Pattern
• Intervention / Treatment: Procedure: graded recession of inferior oblique muscle

Detailed Description

prospective interventional study for forty patients with V pattern strabismus and primary inferior oblique overeaction will be evaluated by prism cover test to assess the grade of IOOA and amplitude of V-pattern. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11-15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA ( more than 15 degree or +3). Simultaneous correction of the horizontal deviation will be performed at the same sitting. Follow up after I week,1 month ,3 month and 6-month.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ELGharbia
    • Tanta, ELGharbia, Egypt, 1333
      • Faculty of medicine
  • El Gharbeya
    • Tanta, El Gharbeya, Egypt, 1333
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cases with V pattern strabismus with the age of the patients will be ≥3 years.

Exclusion Criteria:

• - Structural ocular pathology
• Significant neurodevelopmental delay

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: v pattern exotropia; v pattern exotropia patients with associated inferior oblique overreaction	Procedure: graded recession of inferior oblique muscle; . Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (more than15 degree or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.
Active Comparator: Pattern esotropia; v pattern esotropia patients with inferior oblique overreaction	Procedure: graded recession of inferior oblique muscle; . Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (more than15 degree or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
orthotropia in primary position with no v pattern esotropia or exotropia.	by measuring the distant angle of strabismus in primary and upgaze less than 10prism dioptre.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No Inferior oblique overaction	2.No hypertropia in adducted position.Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degreeor +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA ( 15 or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.	6 month

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: inferior oblique overaction; Vpattern strabismus; graded recession; Dissociated vertical deviation
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia; Esotropia
• Other Study ID Numbers: 34123/9/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No