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

Sponsor

Benha University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05234957

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Exotropia	Procedure: Bilateral Lateral Rectus Recession	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 17, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.
Active Comparator: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Active Comparator: 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

Outcome Measures

Primary Outcome Measures

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

sensory status [one year]
ocular sensory status (fusion and stereopsis). Fusion is assessed using Worth 4-dot test, and is documented as present (+ve) or absent (-ve). Fusion is assessed using Titmus fly test and is recorded as seconds of arc.
surgical complications [one year]
During the follow up period. postoperative surgical complications, such as over correction (consecutive esotropia) and under correction (recurrent exotropia), are recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benha University	Banhā	Qalyubiyya	Egypt	13511

Sponsors and Collaborators

Benha University

Investigators

Principal Investigator: Mohamed Farid, MD, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Fathy Farid, Professor, Benha University

ClinicalTrials.gov Identifier:

NCT05234957

Other Study ID Numbers:

RC1-1-2022

First Posted:

Feb 10, 2022

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Exotropia

Study Results

No Results Posted as of Jun 15, 2022