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Comparison of Medial Rectus Resection and Plication in Exotropic Patients

NCT ID: NCT03768362

Last Updated: 2018-12-07

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2019-05-31

Brief Summary

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Purpose: To determine the surgical outcomes of the plication technique in comparison with the resection method on exotropic patients.

Methods: In this randomized clinical trial, a total of 52 exotropic patients (female, 51.9%) who are candidate for medial rectus strengthening will be randomly classified into plication (n=24) and resection (n=28) groups. The comprehensive visual and ocular examinations will be performed on all study subjects and they will be followed- up for three months postoperatively. Plication technique is the same as resection up to muscle suturing, in the next step, the sutures are passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures.

Detailed Description

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Conditions

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Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Undergoing plication strabismus surgery

Group Type EXPERIMENTAL

Plication strabismus surgery

Intervention Type PROCEDURE

The technique was the same as resection up to muscle suturing, in the next step, the sutures were passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures. At the end, conjunctiva was repaired by vicryl 8/0.

Undergoing resection strabismus surgery

Group Type ACTIVE_COMPARATOR

Resection strabismus surgery

Intervention Type PROCEDURE

resection strabismus surgery

Interventions

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Plication strabismus surgery

The technique was the same as resection up to muscle suturing, in the next step, the sutures were passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures. At the end, conjunctiva was repaired by vicryl 8/0.

Intervention Type PROCEDURE

Resection strabismus surgery

resection strabismus surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients with a residual exotropia and history of uni- or bilateral lateral rectus recession or recession and resection (R \&R) and those exotropic patients who were going to have already recession and resection (R \& R) operation due to unilateral constant exotropia will be considered as eligible cases to be included.

Exclusion Criteria

Subjects with a history of prematurity, intellectual disability, lack of central fixation (nystagmus, eccentric fixation, retinopathy of prematurity) subjects with systemic or other ocular diseases, neurological disorders, uncooperative patients and participants with less than three-month postoperative follow-up will be excluded from this study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamideh Sabbaghi

PhD student, Teacher Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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13112

Identifier Type: -

Identifier Source: org_study_id