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Lateral Rectus Muscle Tendon Elongation

Primary Purpose

Surgical Procedure, Unspecified, Ocular Discomfort, Strabismus, Divergent

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Procedure, Unspecified focused on measuring SENSORY EXOTROPIA, LATERAL RECTUS ELONGATION, AUTOGRAFT

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD.

Exclusion Criteria:

  • Patients with exotropia other than sensory type (alternating exotropia, intermittent exotropia)
  • Angle of deviation less than 50 PD.
  • visual acuity more than 0.2 decimal in affected eye .
  • A or V pattern exotropia.
  • Nystagmus .
  • Refusal of surgery by the adult patients or caregiver of children.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES .

    Arm Description

    Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD, were included in the study.

    Outcomes

    Primary Outcome Measures

    Distant angle of deviation after surgical correction
    Measured by alternate prism cover test for near and far,which is considered successful if within10 prism diopter esotropia or exotropia.
    limitation of adduction and abduction
    measured by a scale from -4 to 0; with-4 implying no adduction or abduction beyond midline, -3 implying for 75% deficit,-2 for 50% deficit,-1 for 25% deficit and 0 for full ductions.
    patient satisfaction with the procedure
    score assesed by questionnaire of 3questions based on satisfaction with degree of alignment, aesthetic appearance, limitation of adduction and abduction. 0: I am not satisfied, 1: I am moderately satisfied, 2: I am satisfied, 3: I am very satisfied, and Iwould recommend it to another. Based on the score (0-3 unsatisfied, 4-6 moderately satisfied, 7-9 very satisfied).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2020
    Last Updated
    February 25, 2020
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04286945
    Brief Title
    Lateral Rectus Muscle Tendon Elongation
    Official Title
    Lateral Rectus Muscle Tendon Elongation by an Auto Graft From the Resected Medial Rectus Muscle as a Monocular Surgery for Large Angle Sensory Exotropia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    June 1, 2018 (Actual)
    Study Completion Date
    September 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate a technique using resected medial rectus muscle transplantation for elongation of Lateral rectus tendon as a monocular surgery for large angle sensory exotropia.
    Detailed Description
    A prospective study done in Tanta university in the period between January 2017 and June 2018.It included 16 patients with sensory exotropia ≥50PD. Full history was taken. Visual acuity, cycloplegic refraction and fundus exam of both eyes was performed prior to surgery. Strabismus angles were measured at near and distance by alternate prism cover test. Any limitation of adduction or abduction was scaled from -4 to 0. Patients were followed for 6 months. SURGICAL PROCEDURE: The MR muscle was dissected through a limbal incision. Two single arm 6-0 Vicryl sutures were placed at desired distance from the insertion as the routine resection of rectus muscle and another pair of 6-0 Vicryl was placed at the insertion. The muscle was then incised from its insertion, and the posteriorly (distally) placed 6-0 Vicryl sutures were passed through the original insertion. The resected segment is then put in saline. A vicryl 6-0 suture was tied at the LR muscle insertion. The muscle was incised from its insertion. Next, the stump of the resected segment was then sutured to the sclera at the desired position measured by the strabismus caliber according to the surgical dosage sufficient to correct the premeasured distant angle (taking into consideration the length of the added segment, which will be added to the amount of recession), and the distal end of this stump was sutured with the proximal end of LR with the 6-0 Vicryl already placed on the LR. Now the elongated muscle was sutured at desired site from the original insertion of LR as done in routine rectus muscle recession. The patients were followed at 1day after surgery, 2 weeks, 3 month, and 6 months. In each visit the distant angle of deviation was measured by prism cover test, any limitation of adduction and abduction was scaled, and patient satisfaction with results at last follow up was obtained, all results were recorded and tabulated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Procedure, Unspecified, Ocular Discomfort, Strabismus, Divergent
    Keywords
    SENSORY EXOTROPIA, LATERAL RECTUS ELONGATION, AUTOGRAFT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    PROSPECTIVE STUDY
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES .
    Arm Type
    Other
    Arm Description
    Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD, were included in the study.
    Intervention Type
    Procedure
    Intervention Name(s)
    LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE
    Other Intervention Name(s)
    Lateral rectus elongation
    Intervention Description
    After resection of the medial rectus muscle, the resected segment is sutured to the lateral rectus muscle after dissection and marking to elongate and slaken the muscle then the elongated muscle is sutured to the sclera at the desired amount of conventional recession.
    Primary Outcome Measure Information:
    Title
    Distant angle of deviation after surgical correction
    Description
    Measured by alternate prism cover test for near and far,which is considered successful if within10 prism diopter esotropia or exotropia.
    Time Frame
    6month
    Title
    limitation of adduction and abduction
    Description
    measured by a scale from -4 to 0; with-4 implying no adduction or abduction beyond midline, -3 implying for 75% deficit,-2 for 50% deficit,-1 for 25% deficit and 0 for full ductions.
    Time Frame
    6month
    Title
    patient satisfaction with the procedure
    Description
    score assesed by questionnaire of 3questions based on satisfaction with degree of alignment, aesthetic appearance, limitation of adduction and abduction. 0: I am not satisfied, 1: I am moderately satisfied, 2: I am satisfied, 3: I am very satisfied, and Iwould recommend it to another. Based on the score (0-3 unsatisfied, 4-6 moderately satisfied, 7-9 very satisfied).
    Time Frame
    after 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD. Exclusion Criteria: Patients with exotropia other than sensory type (alternating exotropia, intermittent exotropia) Angle of deviation less than 50 PD. visual acuity more than 0.2 decimal in affected eye . A or V pattern exotropia. Nystagmus . Refusal of surgery by the adult patients or caregiver of children.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    share data after publication
    IPD Sharing Time Frame
    within 6 month of completion of the study
    IPD Sharing Access Criteria
    after publication in a subspecialized journal reviewed by panel reviewers that has an open access on line

    Learn more about this trial

    Lateral Rectus Muscle Tendon Elongation

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