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

NCT ID: NCT05234957

Last Updated: 2024-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-17

Study Completion Date

2023-05-18

Brief Summary

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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

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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.

Conditions

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Intermittent Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.

Group Type ACTIVE_COMPARATOR

Bilateral Lateral Rectus Recession

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Bilateral Lateral Rectus Recession

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Fathy Farid

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Farid, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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Benha University

Banhā, Qalyubiyya, Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RC1-1-2022

Identifier Type: -

Identifier Source: org_study_id