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

Primary Purpose

Intermittent Exotropia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bilateral Lateral Rectus Recession
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Benha UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Asymmetric bilateral lateral rectus recession (A-BLR)

Symmetric bilateral lateral rectus recession (S-BLR)

Arm Description

The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.

The amount of bilateral lateral rectus recession is equally divided between both eyes.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
surgical complications
During the follow up period. postoperative surgical complications, such as over correction (consecutive esotropia) and under correction (recurrent exotropia), are recorded.

Full Information

First Posted
January 20, 2022
Last Updated
June 13, 2022
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT05234957
Brief Title
Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance
Official Title
Symmetric Versus Asymmetric Bilateral Lateral Rectus Recession in Management of Basic Intermittent Exotropia With Ocular Dominance
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asymmetric bilateral lateral rectus recession (A-BLR)
Arm Type
Active Comparator
Arm Description
The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.
Arm Title
Symmetric bilateral lateral rectus recession (S-BLR)
Arm Type
Active Comparator
Arm Description
The amount of bilateral lateral rectus recession is equally divided between both eyes.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Lateral Rectus Recession
Intervention Description
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 Outcome Measure Information:
Title
ocular alignment at distant fixation
Description
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.
Time Frame
one year
Title
ocular alignment at near fixation
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
sensory status
Description
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.
Time Frame
one year
Title
surgical complications
Description
During the follow up period. postoperative surgical complications, such as over correction (consecutive esotropia) and under correction (recurrent exotropia), are recorded.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Farid, MD
Phone
00201003354636
Email
MOHAMED.FARID@fmed.bu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Farid, MD
Email
mohamed_fathy_10@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Farid, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha University
City
Banhā
State/Province
Qalyubiyya
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Farid, MD
Phone
00201003354636
Email
MOHAMED.FARID@fmed.bu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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