Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Horizontal Deviations
Primary Purpose
Large Angle Horizontal Strabismus
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
botulinum toxin augmented surgery
conventional surgery
Sponsored by
About this trial
This is an interventional treatment trial for Large Angle Horizontal Strabismus focused on measuring botulinum toxin, horizontal strabismus
Eligibility Criteria
Inclusion Criteria:
- Large angle concomitant horizontal strabismus (>50 prism diopters)
Exclusion Criteria:
- Other neurologic, or developmental disorders
- Vertical deviation
- Significant A or V patterns
- Paralytic or restrictive forms of strabismus
- History of eye surgery (strabismus or otherwise)
Sites / Locations
- Ophthalmology department, faculty of medicine, Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botulinum toxin augmented surgery group
conventional surgery group
Arm Description
unilateral recess-resect procedure, or bilateral rectus muscle recession plus intraoperative injection of 2.5 to 5 units of botulinum toxin A into the recessed muscle.
unilateral recess-resect procedure, bilateral rectus muscle recession, or 3 horizontal rectus muscle surgery according to the type of strabismus and the presence or absence of deep amblyopia.The standard correction tables will be used as a guide for the amount of muscle recession and, or resection
Outcomes
Primary Outcome Measures
success rate
Outcomes will be considered successful if the patients had orthotropia ±10 PD
Secondary Outcome Measures
incidence of complications
ptosis vertical deviation under-correction (residual esotropia) overcorrection (consecutive exotropia)
Ocular alignment
Orthotropia or angle of deviation if present
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03266549
Brief Title
Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Horizontal Deviations
Official Title
Botulinum Toxin Augmented Surgery Versus Conventional Surgery in the Management of Large Angle Concomitant Horizontal Deviations
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2021 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
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
Horizontal strabismus includes esotropia and exotropia where there is inward or outward deviation of visual axes of the eyes respectively. The most common initial treatment of horizontal strabismus is either bilateral rectus muscle recessions or unilateral recession resection surgery. For large angle deviations (>50 prism diopters [PD]), surgery on 2 muscles alone may not be adequate with high reoperation rates. Approaches to these patients included large bilateral muscle recessions, supramaximal unilateral recession resection procedure, three or four horizontal muscle surgery, or botulinum toxin augmented surgery.
Botulinum toxin augmentated strabismus surgery was reported in several studies. Owens et al.reported successful botulinum toxin augmentation of monocular recession-resection surgeries in 3 large-angle exotropia patients with successful results in two of the 3 patients. Khan reported 8 patients with > 60 PD esotropia treated with botulinum-augmented surgery. Six of 8 had deviations of 10 PD or less following surgery. Özkan et al used botulinum augmentation in a group of older patients with large angle esotropia of different etiologies, with a success rate of 57%. 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 the effectiveness of intraoperative botulinum toxin augmentation compared to surgery alone.
Detailed Description
Strabismus is defined as inability of the two eyes to align their visual axes to a common object of regard. Horizontal strabismus may be in the form of esotropia or exotropia depending on whether the visual axes and the eyes are converging or diverging respectively.
There are multiple surgical techniques used to treat horizontal strabismus with the main goal being to align the visual axes so that binocular vision may develop. The most common initial treatment is either bilateral rectus muscle recessions or unilateral recession resection surgery. For large angle deviations (>50 prism diopters [PD]), surgery on 2 muscles alone may not be adequate to correct the strabismus with high reoperation rates. Approaches to these patients have included large bilateral muscle recessions, supramaximal unilateral recession resection procedure, three or four horizontal muscle surgery, or botulinum toxin augmented surgery.
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 strabismus surgery was reported in several previous studies. Owens et al. reported the successful intraoperative use of botulinum toxin to augment monocular recession-resection surgeries in three large-angle exotropia patients. Two of these patients had orthotropia ±10 PD at their final examinations, while the third patient demonstrated a stable 18 PD exotropia which was cosmetically satisfactory. Khan reported 8 patients with > 60 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 et al. 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. Minguini et al. compared the results of surgery alone versus surgery plus treatment with botulinum toxin for treatment of 23 patient with large angle strabismus. Lueder et al. 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 time2. 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 the effectiveness of the addition of intraoperative botulinum toxin compared to surgery alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large Angle Horizontal Strabismus
Keywords
botulinum toxin, horizontal strabismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin augmented surgery group
Arm Type
Experimental
Arm Description
unilateral recess-resect procedure, or bilateral rectus muscle recession plus intraoperative injection of 2.5 to 5 units of botulinum toxin A into the recessed muscle.
Arm Title
conventional surgery group
Arm Type
Active Comparator
Arm Description
unilateral recess-resect procedure, bilateral rectus muscle recession, or 3 horizontal rectus muscle surgery according to the type of strabismus and the presence or absence of deep amblyopia.The standard correction tables will be used as a guide for the amount of muscle recession and, or resection
Intervention Type
Procedure
Intervention Name(s)
botulinum toxin augmented surgery
Intervention Description
unilateral recess-resect procedure, or bilateral rectus muscle recession plus intraoperative injection of 2.5 to 5 units of botulinum toxin A into the recessed muscle.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
unilateral recess-resect procedure, bilateral rectus muscle recession, or 3 horizontal rectus muscle surgery according to the type of strabismus and the presence or absence of deep amblyopia. The standard correction tables will be used as a guide for the amount of muscle recession and, or resection.
Primary Outcome Measure Information:
Title
success rate
Description
Outcomes will be considered successful if the patients had orthotropia ±10 PD
Time Frame
Patients will be examined at 1 week after surgery
Secondary Outcome Measure Information:
Title
incidence of complications
Description
ptosis vertical deviation under-correction (residual esotropia) overcorrection (consecutive exotropia)
Time Frame
Patients will be examined at 1 week after surgery
Title
Ocular alignment
Description
Orthotropia or angle of deviation if present
Time Frame
12 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Large angle concomitant horizontal strabismus (>50 prism diopters)
Exclusion Criteria:
Other neurologic, or developmental disorders
Vertical deviation
Significant A or V patterns
Paralytic or restrictive forms of strabismus
History of eye surgery (strabismus or otherwise)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Alattar, Msc
Phone
01004450144
Ext
+2
Email
alattarsara@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Alattar, Msc
Phone
01004450144
Ext
+2
Email
saraalattar@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sara Alattar
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology department, faculty of medicine, Assiut university
City
Assiut
ZIP/Postal Code
71526
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Alattar, Msc
Phone
+201004450144
Email
alattarsara@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohamed Sayed Saad, PhD
Phone
+201001825024
Email
mohsayedsaad@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21996305
Citation
Lueder GT, Galli M, Tychsen L, Yildirim C, Pegado V. Long-term results of botulinum toxin-augmented medial rectus recessions for large-angle infantile esotropia. Am J Ophthalmol. 2012 Mar;153(3):560-3. doi: 10.1016/j.ajo.2011.08.019. Epub 2011 Oct 13.
Results Reference
background
PubMed Identifier
11040475
Citation
Vroman DT, Hutchinson AK, Saunders RA, Wilson ME. Two-muscle surgery for congenital esotropia: rate of reoperation in patients with small versus large angles of deviation. J AAPOS. 2000 Oct;4(5):267-70. doi: 10.1067/mpa.2000.106960.
Results Reference
background
PubMed Identifier
24654800
Citation
Bayramlar H, Karadag R, Yildirim A, Ocal A, Sari U, Dag Y. Medium-term outcomes of three horizontal muscle surgery in large-angle infantile esotropia. J Pediatr Ophthalmol Strabismus. 2014 May-Jun;51(3):160-4. doi: 10.3928/01913913-20140318-02. Epub 2014 Mar 25.
Results Reference
background
PubMed Identifier
15977866
Citation
Minkoff OV, Donahue SP. Three-muscle surgery for infantile esotropia in children younger than age 2 years. J Pediatr Ophthalmol Strabismus. 2005 May-Jun;42(3):144-8; qiuz 174-5. doi: 10.3928/01913913-20050501-01.
Results Reference
background
PubMed Identifier
15828866
Citation
Khan AO. Two horizontal rectus eye muscle surgery combined with botulinum toxin for the treatment of very large angle esotropia. A pilot study. Binocul Vis Strabismus Q. 2005;20(1):15-20.
Results Reference
background
PubMed Identifier
16678746
Citation
Ozkan SB, Topaloglu A, Aydin S. The role of botulinum toxin A in augmentation of the effect of recession and/or resection surgery. J AAPOS. 2006 Apr;10(2):124-7. doi: 10.1016/j.jaapos.2005.11.011.
Results Reference
background
PubMed Identifier
9366672
Citation
McNeer KW, Tucker MG, Spencer RF. Botulinum toxin management of essential infantile esotropia in children. Arch Ophthalmol. 1997 Nov;115(11):1411-8. doi: 10.1001/archopht.1997.01100160581010.
Results Reference
background
PubMed Identifier
10532749
Citation
Owens PL, Strominger MB, Rubin PA, Veronneau-Troutman S. Large-angle exotropia corrected by intraoperative botulinum toxin A and monocular recession resection surgery. J AAPOS. 1998 Jun;2(3):144-6. doi: 10.1016/s1091-8531(98)90004-0.
Results Reference
background
PubMed Identifier
22473411
Citation
Minguini N, de Carvalho KM, Bosso FL, Hirata FE, Kara-Jose N. Surgery with intraoperative botulinum toxin-A injection for the treatment of large-angle horizontal strabismus: a pilot study. Clinics (Sao Paulo). 2012;67(3):279-82. doi: 10.6061/clinics/2012(03)13. No abstract available.
Results Reference
background
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Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Horizontal Deviations
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