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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

Tracking Information
First Submitted Date  ICMJE August 26, 2017
First Posted Date  ICMJE August 30, 2017
Last Update Posted Date August 30, 2017
Estimated Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2017)
  • incidence of complications [ Time Frame: Patients will be examined at 1 week after surgery ]
    ptosis vertical deviation under-correction (residual esotropia) overcorrection (consecutive exotropia)
  • Ocular alignment [ Time Frame: 12 months postoperative ]
    Orthotropia or angle of deviation if present
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Infantile Esotropia
Official Title  ICMJE Botulinum Toxin Augmented Surgery Versus Conventional Surgery in the Management of Large Angle Infantile Esotropia
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.
Detailed Description

Infantile esotropia is defined as the onset of constant esodeviation in children less than 6 months of age.There are several other clinical findings that often accompany infantile esotropia including: large amplitude of the angle (greater than 30 prism diopters), dissociated vertical deviation, dissociated horizontal deviation, inferior oblique overaction, latent nystagmus, cross fixation with pseudo abduction deficit, low degree of hyperopia (less than 3 diopters), and amblyopia. The incidence of infantile esotropia is approximately 1%,making this an important issue for pediatric ophthalmologist.

There are multiple surgical techniques used to treat infantile esotropia with the main goal being to align the eyes so that binocular vision may develop.The most common initial treatment is either bilateral medial rectus muscle recessions or unilateral medial rectus muscle recession and lateral rectus muscle resection. For infants with very large angles of esotropia (>60 prism diopters [PD]), surgery on 2 muscles alone may not be adequate to correct the strabismus. Approaches to these patients have included large bilateral medial rectus muscle recessions, smaller bilateral medial rectus muscle recessions combined with resections of 1 or both lateral rectus muscles or botulinum toxin augmented bimedial recession.

Historically, the success of surgery for infants with large-angle esotropia was limited by the amount of medial rectus muscle recession that was considered safe. Initially, most surgeons restricted their medial rectus recessions to approximately 5 mm, anticipating an under correction that could be addressed with lateral rectus muscle resections during a second surgery. Over time, the maximal amount considered safe for medial rectus muscle recession has increased, and now most surgeons are comfortable performing 6- to 7-mm recessions in patients with large-angle esotropia.Others have recommended small medial rectus muscle recessions combined with unilateral or bilateral lateral muscle resections, because of the potential risk of overcorrection with large medial rectus muscle recessions. Other studies reported the use of botulinum toxin augmentation of medial rectus muscle recession in patients with large-angle infantile esotropia.

Botulinum toxin exerts its effect by interfering with release of acetylcholine at the neuromuscular junction, thus inhibiting muscle contraction. Although the pharmacologic effect of botulinum toxin is temporary, permanent results in patients with strabismus may occur. These effects include a change in the length-tension curves of the muscles and permanent changes in sarcomere density and myosin heavy chain composition.

Botulinum toxin alone has been advocated by McNeer and associates as a primary treatment for infantile esotropia in children with smaller angles of deviation. The advantage of this approach is that incisional surgery is not required. However, it was found that botulinum alone was less effective in establishing binocularity when compared to standard surgery. This is likely because multiple injections are often needed,which prolongs the duration of misalignment.On the other hand,the concomitant use of botulinum toxin and surgery allowed for rapid establishment of alignment. Other advantages of botulinum augmentation are that only 2 muscles are operated upon, thus decreasing anesthesia duration and the risk of surgical complications, and the lateral rectus muscles are preserved for additional surgery, if needed.

Botulinum toxin augmentation of medial rectus muscle recession was reported in three previous studies. Khan reported 8 patients with > 60 prism diopters (PD) esotropia treated with botulinum-augmented horizontal muscle surgery.Six of 8 had deviations of 10 PD or less following surgery, with an average follow-up of 9 months. Özkan and associates used botulinum augmentation in a group of older patients (age range 5-50 years) with large-angle esotropia of different etiologies, with a success rate of 57% and an average follow-up of 14 months.Lueder and associates evaluated the long-term outcomes in patients with infantile esotropia who had been followed for more than 2 years after treatment. The results were good, with a 74% success rate.This study demonstrated that this procedure is an effective treatment for infants with large-angle infantile esotropia, with stable results over time. Based on historical comparisons, it 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.

This study aims to assess the efficacy and safety of botulinum toxin augmented medial rectus recession compared to conventional surgery in the management of large angle infantile esotropia.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infantile Esotropia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: botulinum toxin augmented surgery
  • Active Comparator: conventional surgery group
    bilateral MR muscle recessions combined with unilateral or bilateral LR muscle resections (according to the standard correction tables)
    Intervention: Procedure: conventional surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 28, 2017)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03266549
Other Study ID Numbers  ICMJE Botox Esotropia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sara Alattar, MD, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: sara Alattar Assiut University
PRS Account Assiut University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP