Comparison of Medial Rectus Resection and Plication in Exotropic Patients

• ClinicalTrials.gov Identifier: NCT03768362
• Recruitment Status: Unknown
• First Posted: December 7, 2018
• Last Update Posted: December 7, 2018
• Sponsor: Shahid Beheshti University of Medical Sciences
• Information provided by (Responsible Party): Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Exotropia	Procedure: Plication strabismus surgery; Procedure: Resection strabismus surgery	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Postoperative ocular deviation [ Time Frame: three months ]
   Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Hamideh Sabbaghi, PhD student, Teacher Assistant, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03768362
• Other Study ID Numbers: 13112
• First Posted: December 7, 2018
• Last Update Posted: December 7, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Exotropia; Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases