Comparison of Medial Rectus Resection and Plication in Exotropic Patients

Study Overview
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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.

Official Title
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Comparison of Medial Rectus Resection and Plication in Exotropic Patients

Conditions
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Exotropia

Intervention / Treatment
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* Procedure: Plication strabismus surgery
* Procedure: Resection strabismus surgery


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Undergoing plication strabismus surgery<br> | Procedure: Plication strabismus surgery<br>* 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.<br>|
| Active Comparator: Undergoing resection strabismus surgery<br> | Procedure: Resection strabismus surgery<br>* resection strabismus surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative ocular deviation | Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery. | three months |