Comparison of Medial Rectus Resection and Plication in Exotropic Patients

NCT03768362 | Unknown Phase 2 DMC

• 1 other identifier: 13112
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exotropia

Outcome Measures

Primary Outcomes (1)

• Postoperative ocular deviation

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

  three months

Study Arms (2)

Undergoing plication strabismus surgery

EXPERIMENTAL

Procedure: Plication strabismus surgery

Undergoing resection strabismus surgery

ACTIVE COMPARATOR

Procedure: Resection strabismus surgery

Interventions

Plication strabismus surgery PROCEDURE

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.

Undergoing plication strabismus surgery

Resection strabismus surgery PROCEDURE

resection strabismus surgery

Undergoing resection strabismus surgery

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Teacher Assistant

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: December 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 7, 2018

Record last verified: 2018-12