Comparison of Medial Rectus Resection and Plication in Exotropic Patients

Exotropia Clinical Trial

Official title:

Comparison of Medial Rectus Resection and Plication in Exotropic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03768362
• Other study ID #: 13112
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2018
• Est. completion date: May 2019

Study information

• Verified date: December 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: May 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Exotropia

Intervention

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.
• Resection strabismus surgery
resection strabismus surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative ocular deviation	Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.	three months