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Comparison of Medial Rectus Resection and Plication in Exotropic Patients

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ClinicalTrials.gov Identifier: NCT03768362
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences

Study Description
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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
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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
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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
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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
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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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: Hamideh Sabbaghi, PhD student, Teacher Assistant, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03768362     History of Changes
Other Study ID Numbers: 13112
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
 Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases