A Phase 2/3 interventional study of Plication strabismus surgery and Resection strabismus surgery in Exotropia, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's planned enrollment of 52 is close to the median of 50 across 49 interventional studies indexed under Exotropia.
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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.
Procedure: Plication strabismus surgery
Procedure: Resection 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.
resection strabismus surgery
Postoperative ocular deviation
Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.
Time frame: three months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences →