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

Not Applicable

Completed

• Conditions: Intermittent Exotropia
• Interventions: Procedure: Bilateral Lateral Rectus Recession

• Registration Number: NCT05234957
• Lead Sponsor: Benha University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-10
• Study Start: 2022-04-17
• Primary Completion: 2023-04-18
• Study Completion: 2023-05-18
• Results First Submitted: 2024-02-15
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-26
• Last Update Submitted: 2024-10-26
• Results First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asymmetric bilateral lateral rectus recession (A-BLR)	Bilateral Lateral Rectus Recession	The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.
Symmetric bilateral lateral rectus recession (S-BLR)	Bilateral Lateral Rectus Recession	The amount of bilateral lateral rectus recession is equally divided between both eyes.

Primary Outcome Measures

Name	Time	Method
Ocular Alignment at Distant Fixation	one year	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.
Ocular Alignment at Near Fixation	one year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, Qalyubiyya, Egypt