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Comparison of Medial Rectus Resection and Plication in Exotropic Patients

Primary Purpose

Exotropia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Plication strabismus surgery
Resection strabismus surgery
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exotropia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Undergoing plication strabismus surgery

    Undergoing resection strabismus surgery

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 6, 2018
    Last Updated
    December 6, 2018
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03768362
    Brief Title
    Comparison of Medial Rectus Resection and Plication in Exotropic Patients
    Official Title
    Comparison of Medial Rectus Resection and Plication in Exotropic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    February 2019 (Anticipated)
    Study Completion Date
    May 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exotropia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Undergoing plication strabismus surgery
    Arm Type
    Experimental
    Arm Title
    Undergoing resection strabismus surgery
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Plication strabismus surgery
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Resection strabismus surgery
    Intervention Description
    resection strabismus surgery
    Primary Outcome Measure Information:
    Title
    Postoperative ocular deviation
    Description
    Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.
    Time Frame
    three months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Comparison of Medial Rectus Resection and Plication in Exotropic Patients

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