ClinicalTrials.Veeva

Menu

Comparison of Medial Rectus Resection and Plication in Exotropic Patients

S

Shahid Beheshti University of Medical Sciences

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Exotropia

Treatments

Procedure: Resection strabismus surgery
Procedure: Plication strabismus surgery

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 2 patient groups

Undergoing plication strabismus surgery
Experimental group
Treatment:
Procedure: Plication strabismus surgery
Undergoing resection strabismus surgery
Active Comparator group
Treatment:
Procedure: Resection strabismus surgery

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems