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NCT Number: NCT05234957

Symmetric vs Asymmetric BLR Recession in Management of Basic IXT 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.

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Key information

Conditions

Intermittent Exotropia

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Qalyubiyya, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral Lateral Rectus Recession

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.

Primary outcomes

  1. Ocular Alignment at Distant Fixation

    Time frame: 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.

  2. Ocular Alignment at Near Fixation

    Time frame: 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 outcomes

  1. Sensory Status (Stereopsis)

    Time frame: one year

    ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.

  2. Sensory Status (Fusion)

    Time frame: one year

    Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: IXT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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