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

Intermittent Exotropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234957
• Other study ID #: RC1-1-2022
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2022
• Est. completion date: May 2023

Study information

• Verified date: June 2022
• Source: Benha University
• Contact: Mohamed Farid, MD
• Phone: 00201003354636
• Email: MOHAMED.FARID[@]fmed.bu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Benha University	Banha	Qalyubiyya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	sensory status	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.	one year
Secondary	surgical complications	During the follow up period. postoperative surgical complications, such as over correction (consecutive esotropia) and under correction (recurrent exotropia), are recorded.	one year