Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles

NCT ID: NCT05643456

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-12-30

Brief Summary

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Comparison Between The Results Of Two Muscles Surgery And Three Muscles Surgery For The Treatment Of Large Angle Exotropia

Detailed Description

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Exotropia is classified as Primary which includes constant and intermittent exotropias. Secondary XT include Sensory and consecutive XT. Management for IXT consists of non-surgical and surgical treatment. There is some controversy regarding the optimal surgical method varying between bilateral lateral rectus recession (BLR), unilateral lateral rectus recession-medial rectus resection (RR) and bilateral medial rectus resection (BMR).

Conditions

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Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group will do two muscles surgery; bilateral lateral rectus recession. The 2nd group will do three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1 :Two muscle surgery

30 patients will underwent two muscle surgery(bilateral lateral rectus muscle recession)

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group 30 patients had two muscles surgery; bilateral lateral rectus recession.

The 2nd group 39 patients had three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.

group 2:Three muscle surgery

39 patients underwent three muscle surgery(bilateral lateral rectus muscle recession with unilateral medial rectus muscle tucking)

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group 30 patients had two muscles surgery; bilateral lateral rectus recession.

The 2nd group 39 patients had three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.

Interventions

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surgery

69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group 30 patients had two muscles surgery; bilateral lateral rectus recession.

The 2nd group 39 patients had three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type.

Exclusion Criteria

1. Angle of deviation less than 40 PD or more than 55 PD.
2. History of previous surgery.
3. Inconcomitant exotropia.
4. Incomitance in any gaze.
5. Associated vertical deviation(oblique dysfunction,A or V pattern).
6. Patients with neurological deficit.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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reham fawzy elsherbiny

assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lobna MH Khazbm, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Reham fawzy elsherbiny

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RIO

Identifier Type: -

Identifier Source: org_study_id

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