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Evaluation of The Techniques in Correcting Large-Angle Exotropia

Primary Purpose

Exotropia, Evaluation of Surgical Techniques in Correcting Exotropia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Evaluation of The Techniques of Lateral Rectus Muscle Combined Recession with Hang Back and Combined Recession with Z-Tenotomy in Correcting Large-Angle Exotropia
Sponsored by
Tanta University
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 suffering from large angle exotropia; defined, in this study, as an angle of deviation ≥ 40 prism diopters (PD). Exclusion Criteria: Patients suffering from exotropia with angle < 40 prism diopters (PD). Patient with paralytic strabismus. Patient with restrictive strabismus. Patient with combined vertical and horizontal deviation. Patients with previous strabismus surgery. Patients who had previously been administered botulinum toxin A. Patient refusal.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    combined lateral rectus muscle recession 7mm and hang back technique.

    combined lateral rectus muscle recession 7mm and Z- tenotomy technique.

    Arm Description

    The technique of combined LR recession 7mm and hang back technique: A. The muscle is exposed in the usual manner and locking suture is passed through full thickness of the LR muscle using nonabsorbable ethibond suture. B. The muscle is cut from its insertion site. C. Marking the sclera for the rectus muscle recession. a Measurement from the limbus, or b measurement from the original insertion site. D. Passage of the needles in the sclera using the "crossed swords" Technique E. The muscle has been pulled up to its new insertion point and the sutures have been tied and cut and the remainder of the procedure is identical to the standard hang-back method. The

    The technique of lateral rectus muscle Z-tenotomy: A. The muscle is exposed in the usual manner and two hemostats are each placed 80% of the way across the muscle (or tendon) from opposite borders. The hemostats are placed 3 or 4 mm apart. B. The posterior hemostat is removed, and scissors are used to cut across the muscle in the crushed area. By cutting the muscle in the crushed area, bleeding is kept to a minimum. C. The hemostat nearer the insertion is removed, and the muscle is cut along the crushed area using small snips with scissors. D. lengthening of the muscle will occur. Any bleeding is controlled with pressure. E. After the distal myotomy has been performed, in a very tight muscle, a No. 15 Bard Parker blade can be used to divide the tendon fibers, cutting against the muscle hook. This can be accomplished with a scraping motion with the knife blade at nearly right angles to avoid scleral perforation.

    Outcomes

    Primary Outcome Measures

    sucessful alignment
    Successful motor alignment will be defined as orthotropia or ≤ 10 Δ Exotropia or Esotropia at 6 m distance with spectacle correction worn at 6 months. Successful sensory alignment will be by achievement of fusion and moderate or good stereoacuity postoperatively.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2023
    Last Updated
    October 9, 2023
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06084442
    Brief Title
    Evaluation of The Techniques in Correcting Large-Angle Exotropia
    Official Title
    Evaluation of The Techniques of Lateral Rectus Muscle Combined Recession With Hang Back and Combined Recession With Z-Tenotomy in Correcting Large-Angle Exotropia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the techniques of combined lateral rectus muscle recession with hang back and combined lateral rectus muscle recession with z-tenotomy in correcting large-angle exotropia.
    Detailed Description
    Strabismus was defined as any heterotropia at near or distance fixation, or both, on cover testing. Micro strabismus was known as a deviation of fewer than 10 prism diopters (PD). Different studies have defined large angle deviation as 35 Δ , 40 Δ, 50 Δ and 60 Δ. Studies revealed that during the first decade of life, exotropia is most prevalent with intermittent exotropia and convergence insufficiency are the most frequent. Exotropic deviations include exophoria, infantile exotropia, intermittent exotropia, sensory exotropia and consecutive exotropia. Large-angle constant exotropia has a negative impact on the patients and surgical treatment of exodeviations improves the patient's psychosocial functioning. Hence, many surgical techniques have been described for management of exotropia, including bilateral lateral rectus recessions or recess/resect procedures. Botulinum toxin injection combined with recession-resection procedures was used as another surgical technique. As a fact large-angle exotropia usually requires greater amounts of surgery, often a surgery on a greater number of extraocular muscles. Hence, 3 or 4 horizontal muscle surgery was performed for correcting large angle exotropia. Single-staged three horizontal muscles surgery for large angle intermittent exotropia has been more successful. Recently, medial rectus muscle surgery as bilateral medial rectus resection for primary large-angle exotropia has been used with successful results. A successful outcome of surgery was defined as deviation within 10 prism diopters for both distance and near. Moreover, hang-back loop suspension surgical technique can be performed for lateral rectus (LR) muscle recession. This technique can offer potential advantages over the conventional rectus muscle recession, including better exposure of the site of scleral sutures, lower risk of scleral perforation , shorter procedure duration and lower postoperative induced astigmatism. On the other hand, the hang-back recession has some limitations as a potential unpredictability in surgical outcomes.Although previous reports suggest that the hang-back technique for LR recession for exotropia results in poorer surgical success and may require a different surgical dosage, another study proved that the hang-back surgical technique was as effective as conventional LR recession surgery for children with exotropia. Furthermore, many studies were performed on Z-tenotomy technique as an alternative procedure for muscle weakening. This technique was applied for superior oblique muscle in cases with mild to moderate over depression in adduction with success rate 90%. An Other study has revealed that z-tenotomy up to 50% progressively reduces extraocular tendon force transmission, but Z-tenotomy of ≥50% is biomechanically equivalent in vitro to complete tenotomy. In the past it was thought that muscle recessions with the muscle placed behind the anatomical equator of the globe would cause limitation of ocular rotation. Postoperative abduction limitation is one of the main problems in large recession and/or resection for primary and recurrent exotropia with large angle. It is generally thought that keeping the lateral rectus recession to no more than 8 mm prevents this complication. However, several studies revealed that large amounts of recession can be done without causing significant ocular movement limitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exotropia, Evaluation of Surgical Techniques in Correcting Exotropia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be divided into 2 groups: Group (A): Patients will undergo combined LR recession 7mm and hang back technique. Group (B): Patients will undergo combined LR recession 7mm and Z-tenotomy technique.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    combined lateral rectus muscle recession 7mm and hang back technique.
    Arm Type
    Active Comparator
    Arm Description
    The technique of combined LR recession 7mm and hang back technique: A. The muscle is exposed in the usual manner and locking suture is passed through full thickness of the LR muscle using nonabsorbable ethibond suture. B. The muscle is cut from its insertion site. C. Marking the sclera for the rectus muscle recession. a Measurement from the limbus, or b measurement from the original insertion site. D. Passage of the needles in the sclera using the "crossed swords" Technique E. The muscle has been pulled up to its new insertion point and the sutures have been tied and cut and the remainder of the procedure is identical to the standard hang-back method. The
    Arm Title
    combined lateral rectus muscle recession 7mm and Z- tenotomy technique.
    Arm Type
    Active Comparator
    Arm Description
    The technique of lateral rectus muscle Z-tenotomy: A. The muscle is exposed in the usual manner and two hemostats are each placed 80% of the way across the muscle (or tendon) from opposite borders. The hemostats are placed 3 or 4 mm apart. B. The posterior hemostat is removed, and scissors are used to cut across the muscle in the crushed area. By cutting the muscle in the crushed area, bleeding is kept to a minimum. C. The hemostat nearer the insertion is removed, and the muscle is cut along the crushed area using small snips with scissors. D. lengthening of the muscle will occur. Any bleeding is controlled with pressure. E. After the distal myotomy has been performed, in a very tight muscle, a No. 15 Bard Parker blade can be used to divide the tendon fibers, cutting against the muscle hook. This can be accomplished with a scraping motion with the knife blade at nearly right angles to avoid scleral perforation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Evaluation of The Techniques of Lateral Rectus Muscle Combined Recession with Hang Back and Combined Recession with Z-Tenotomy in Correcting Large-Angle Exotropia
    Intervention Description
    Patients will be divided into 2 groups: Group (A): Patients will undergo combined LR recession 7mm and hang back technique. Group (B): Patients will undergo combined LR recession 7mm and Z-tenotomy technique.
    Primary Outcome Measure Information:
    Title
    sucessful alignment
    Description
    Successful motor alignment will be defined as orthotropia or ≤ 10 Δ Exotropia or Esotropia at 6 m distance with spectacle correction worn at 6 months. Successful sensory alignment will be by achievement of fusion and moderate or good stereoacuity postoperatively.
    Time Frame
    Follow up period of 6 month from the time of initial surgery. All patients will be examined at one week, one month, 3 month and 6 months.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suffering from large angle exotropia; defined, in this study, as an angle of deviation ≥ 40 prism diopters (PD). Exclusion Criteria: Patients suffering from exotropia with angle < 40 prism diopters (PD). Patient with paralytic strabismus. Patient with restrictive strabismus. Patient with combined vertical and horizontal deviation. Patients with previous strabismus surgery. Patients who had previously been administered botulinum toxin A. Patient refusal.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Basma Gamal Mohamed Ahmed Sayed Ahmed, Msc
    Phone
    +20 1017954454
    Email
    basmagamal9090@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Lotfi Ali, MD
    Phone
    +20 1223407373
    Email
    ahmedlotfi@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    El-Sayed Samir Arafa, MD
    Organizational Affiliation
    Tanta University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Amr Mahmoud Awara, MD
    Organizational Affiliation
    Tanta University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Heba Mohamed Shafik, MD
    Organizational Affiliation
    Tanta University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11997802
    Citation
    Livir-Rallatos G, Gunton KB, Calhoun JH. Surgical results in large-angle exotropia. J AAPOS. 2002 Apr;6(2):77-80. doi: 10.1067/mpa.2002.122059.
    Results Reference
    background
    PubMed Identifier
    26098544
    Citation
    Chen JH, Morrison DG, Donahue SP. Three and Four Horizontal Muscle Surgery for Large Angle Exotropia. J Pediatr Ophthalmol Strabismus. 2015 Sep-Oct;52(5):305-10. doi: 10.3928/01913913-20150609-02. Epub 2015 Jun 15.
    Results Reference
    background
    PubMed Identifier
    15956942
    Citation
    Chung AK, Rehman SU, Bradbury JA. Comparison of modified anchored "hang-back technique (HBT)" with conventional HBT in bimedial rectus recession. J AAPOS. 2005 Jun;9(3):234-9. doi: 10.1016/j.jaapos.2005.02.011.
    Results Reference
    background
    PubMed Identifier
    17069557
    Citation
    Betts C, Olitsky S. Corneal astigmatic effects of conventional recession vs suspension recession ("hang-back") strabismus surgery: a pilot study. Binocul Vis Strabismus Q. 2006;21(4):211-3.
    Results Reference
    background
    PubMed Identifier
    17920319
    Citation
    Orlin A, Mills M, Ying GS, Liu C. A comparison of hang-back with conventional recession surgery for exotropia. J AAPOS. 2007 Dec;11(6):597-600. doi: 10.1016/j.jaapos.2007.06.001. Epub 2007 Oct 24.
    Results Reference
    background
    PubMed Identifier
    24321425
    Citation
    Shin A, Yoo L, Demer JL. Biomechanics of superior oblique Z-tenotomy. J AAPOS. 2013 Dec;17(6):612-7. doi: 10.1016/j.jaapos.2013.09.004.
    Results Reference
    background

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    Evaluation of The Techniques in Correcting Large-Angle Exotropia

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