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Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Infantile Esotropia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03266549
Recruitment Status : Unknown
Verified August 2017 by Sara Alattar, MD, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Sara Alattar, MD, Assiut University

Brief Summary:
Infantile esotropia is defined as the onset of constant convergent squint in children less than 6 months of age. Infantile esotropia is mainly treated surgically using either bilateral medial rectus muscle recessions or unilateral medial rectus muscle recession and lateral rectus muscle resection with the main goal being to align the eyes so that single binocular vision may develop. For infants with very large angles of esotropia (>60 prism diopters (PD)), surgery on 2 muscles alone may not be adequate. Approaches to these patients have included large bilateral medial rectus muscle (MR) recessions, smaller bilateral medial rectus muscle recessions combined with resections of 1 or both lateral rectus muscles (LR) or botulinum toxin augmented bimedial recession. Botulinum toxin augmentation of medial rectus muscle recession was reported in three previous studies. Lueder et al evaluated the long-term outcomes in patients with infantile esotropia. The results were good, with a 74% success rate. Based on historical comparisons, this technique appears equally as effective as 3- or 4-muscle surgery and more effective than large bilateral medial rectus recessions alone. Ideally, a prospective randomized study should be performed to more definitively determine which of these approaches is best.

Condition or disease Intervention/treatment Phase
Infantile Esotropia Procedure: botulinum toxin augmented surgery Procedure: conventional surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Augmented Surgery Versus Conventional Surgery in the Management of Large Angle Infantile Esotropia
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botulinum toxin augmented surgery group
bilateral 7.0-mm medial rectus muscle recessions, with augmentation with 1.25units of botulinum toxin in 1 muscle for patients with deviations of 65 to 70 PD, and 2.5 units (either 1.25 units in both muscles or 2.5 units in 1 muscle) for patients with deviations greater than 70 PD
Procedure: botulinum toxin augmented surgery
bilateral 7.0-mm medial rectus muscle recessions, with augmentation with 1.25units of botulinum toxin in 1 muscle for patients with deviations of 65 to 70 PD, and 2.5 units (either 1.25 units in both muscles or 2.5 units in 1 muscle) for patients with deviations greater than 70 PD

Active Comparator: conventional surgery group
bilateral MR muscle recessions combined with unilateral or bilateral LR muscle resections (according to the standard correction tables)
Procedure: conventional surgery
bilateral MR muscle recessions combined with unilateral or bilateral LR muscle resections (according to the standard correction tables )
Other Name: three to four horizontal muscle surgery




Primary Outcome Measures :
  1. success rate [ Time Frame: Patients will be examined at 1 week after surgery ]
    Outcomes will be considered successful if the patients had orthotropia ±10 PD


Secondary Outcome Measures :
  1. incidence of complications [ Time Frame: Patients will be examined at 1 week after surgery ]
    ptosis vertical deviation under-correction (residual esotropia) overcorrection (consecutive exotropia)

  2. Ocular alignment [ Time Frame: 12 months postoperative ]
    Orthotropia or angle of deviation if present



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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Large angle infantile esotropia (>60 prism diopters)

Exclusion Criteria:

  • Other neurologic, ocular, or developmental disorders
  • Oblique muscle dysfunction
  • Vertical deviation
  • Significant A or V patterns
  • Paralytic or restrictive forms of strabismus
  • History of eye surgery (strabismus or otherwise)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266549


Contacts
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Contact: Sara Alattar 01004450144 ext +2 alattarsara@yahoo.com
Contact: Sara Alattar 01004450144 ext +2 saraalattar@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: sara Alattar Assiut University
Publications:

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Responsible Party: Sara Alattar, MD, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03266549    
Other Study ID Numbers: Botox Esotropia
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
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
Keywords provided by Sara Alattar, MD, Assiut University:
botulinum toxin
infantile esotropia
Additional relevant MeSH terms:
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Esotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs