Management of Consecutive Exotropia

Management of Consecutive Exotropia and Its Effect on Ocular Motility

Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession

Study Overview

• Status: Completed
• Conditions: Strabismus; Concomitant Squint; Divergent Strabismus
• Intervention / Treatment: Procedure: Strabismus surgery

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minia
    • Minya, Minia, Egypt, 61111
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with consecutive exotropia.
• Eight years old or more.
• Cooperative patients.

Exclusion Criteria:

• Adduction deficit.
• Mental disability.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medial rectus advancement with resection; Surgery will be done to strengthen the medial rectus muscle with resection and anterior displacement again to the original insertion site 5 mm from limbus	Procedure: Strabismus surgery; Strengthening of medial rectus muscle or strengthening of medial rectus muscle with weakening of the lateral rectus muscle
Active Comparator: Medial rectus advancement with lateral rectus recession; Surgery will be done to strengthen the medial rectus muscle with anterior displacement again to the original insertion site 4- 5 mm from limbus with weakening procedure to the lateral rectus muscle at the same time	Procedure: Strabismus surgery; Strengthening of medial rectus muscle or strengthening of medial rectus muscle with weakening of the lateral rectus muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with satisfactory postoperative alignment	Efficacy of each surgical procedure and its further effect using prism cover test to access postoperative alignment of the eye	6 months

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Sahar TA Abdelaziz, MD, Faculty of Medicine, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: Strabismus

Drug and device information, study documents

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