Comparison of Medial Rectus Resection and Plication in Exotropic Patients
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|ClinicalTrials.gov Identifier: NCT03768362|
Recruitment Status : Unknown
Verified December 2018 by Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Exotropia||Procedure: Plication strabismus surgery Procedure: Resection strabismus surgery||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Comparison of Medial Rectus Resection and Plication in Exotropic Patients|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2019|
|Experimental: Undergoing plication strabismus surgery||
Procedure: 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.
|Active Comparator: Undergoing resection strabismus surgery||
Procedure: Resection strabismus surgery
resection strabismus surgery
- Postoperative ocular deviation [ Time Frame: three months ]Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.