Comparison of Medial Rectus Resection and Plication in Exotropic Patients

Phase 2

• Conditions: Exotropia
• Interventions: Procedure: Resection strabismus surgery; Procedure: Plication strabismus surgery

• Registration Number: NCT03768362
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Last Update Submitted: 2018-12-06
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-07
• Primary Completion: 2019-02
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Undergoing resection strabismus surgery	Resection strabismus surgery	-
Undergoing plication strabismus surgery	Plication strabismus surgery	-

Primary Outcome Measures

Name	Time	Method
Postoperative ocular deviation	three months	Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.