Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance (IXT)

Symmetric Versus Asymmetric Bilateral Lateral Rectus Recession in Management of Basic Intermittent Exotropia With Ocular Dominance

The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.

Study Overview

• Status: Completed
• Conditions: Intermittent Exotropia
• Intervention / Treatment: Procedure: Bilateral Lateral Rectus Recession

Detailed Description

Surgical management of basic -type intermittent exotropia with a dominant eye is controversial. Some surgeons do traditional symmetrical bilateral lateral rectus recession, while other perform unilateral recess-resect procedure in the non-dominant eye. The aim of this study is to investigate the effect of two different strategies of bilateral lateral rectus recession; symmetrical recession in which the amount of recession is equally divided between both eyes, and asymmetrical recession, in which the amount of recession is 2mm more in the non-dominant. Outcome measures include ocular deviation at distant and near fixation, sensory status and complications.

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

Contacts and Locations

Study Locations

• Egypt
  • Qalyubiyya
    • Banhā, Qalyubiyya, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Basic-type intermittent exotropia
• Simulated distant-type intermittent exotropia

Exclusion Criteria:

• Alternating basic-type intermittent exotropia (no ocular dominance)
• Distant-type intermittent exotropia
• Convergence-insufficiency type intermittent exotropia
• Constant exotropia
• Sensory exotropia
• Deep amblyopia
• Paralytic or restrictive exotropia
• Previous extraocular muscle surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.	Procedure: Bilateral Lateral Rectus Recession; Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.
Active Comparator: Group 2; Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.	Procedure: Bilateral Lateral Rectus Recession; Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Alignment at Distant Fixation	ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.	one year
Ocular Alignment at Near Fixation	ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Status (Stereopsis)	ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.	one year
Sensory Status (Fusion)	Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).	one year

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Mohamed Farid, MD, Benha University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2022
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

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: RC1-1-2022

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