Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
63 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-16
Study Completion Date
2023-07-31
Brief Summary
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The purpose of the study is to evaluate if strabismus can be successfully treated requiring less surgical interventions with a Botox-based treatment regimen compared to a purely surgery based treatment regimen.
Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.
Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No investigational product is used.
In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.
As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.
Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The objective is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients. In a best case scenario, the results from this trial will prevent strabismus operation for many children with acquired large angle esotropia.
Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.
Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No investigational product is used.
In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.
As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.
Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The objective is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients. In a best case scenario, the results from this trial will prevent strabismus operation for many children with acquired large angle esotropia.
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Detailed Description
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Patients with acquired large angle esotropia (an inward deviation of the ocular axis by more than 5°) that develops after one year of age have a potential to regain binocular vision if a retinal image appears on corresponding retinal areas of both eyes. The main goal of therapy in these patients is the restoration of binocular vision.
In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.
As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.
Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The goal is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients.
The goal of the study is to test if, with a botulinum-toxin-based treatment regimen, strabismus can be successfully treated requiring less surgical interventions.
The primary objective is to test if the Botox-based treatment regimen is not inferior to surgical treatment in terms of orthotropic success. If this is shown, the number of surgeries required will be compared between the two groups (main secondary objective).
The hypothesis is that the Botox-based treatment regimen, which permits performance of rescue surgery, is successful in a similar proportion of patients as the purely surgical approach. The second hypothesis is that only about 20% of patients treated with Botox require surgery at all as compared to about 10% of patients in the surgical arm that need a second surgery.
Analysis of the primary outcome The proportion of orthotropic success for both groups will be calculated with a corresponding 95% confidence interval. For the comparison between the two groups, the stratified risk difference for the stratification factors used in randomization will be calculated with a corresponding one-sided lower 95% confidence limit. If the lower limit lies above -12%, non-inferiority will be claimed.
Analysis of the main secondary outcome The proportion of second interventions for both groups will be calculated with a corresponding 95% confidence interval. For the comparison between the two groups, a stratified risk difference for the stratification factors used in randomization will be calculated with a corresponding one-sided upper 95% confidence limit. If the upper limit lies below 40% and if non-inferiority for the primary outcome could be demonstrated, a clinical benefit of the new treatment will be claimed.
In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively.
As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy.
Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The goal is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients.
The goal of the study is to test if, with a botulinum-toxin-based treatment regimen, strabismus can be successfully treated requiring less surgical interventions.
The primary objective is to test if the Botox-based treatment regimen is not inferior to surgical treatment in terms of orthotropic success. If this is shown, the number of surgeries required will be compared between the two groups (main secondary objective).
The hypothesis is that the Botox-based treatment regimen, which permits performance of rescue surgery, is successful in a similar proportion of patients as the purely surgical approach. The second hypothesis is that only about 20% of patients treated with Botox require surgery at all as compared to about 10% of patients in the surgical arm that need a second surgery.
Analysis of the primary outcome The proportion of orthotropic success for both groups will be calculated with a corresponding 95% confidence interval. For the comparison between the two groups, the stratified risk difference for the stratification factors used in randomization will be calculated with a corresponding one-sided lower 95% confidence limit. If the lower limit lies above -12%, non-inferiority will be claimed.
Analysis of the main secondary outcome The proportion of second interventions for both groups will be calculated with a corresponding 95% confidence interval. For the comparison between the two groups, a stratified risk difference for the stratification factors used in randomization will be calculated with a corresponding one-sided upper 95% confidence limit. If the upper limit lies below 40% and if non-inferiority for the primary outcome could be demonstrated, a clinical benefit of the new treatment will be claimed.
Conditions
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Acquired Esotropia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Botox-based treatment regimen
First intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed.
Group Type
EXPERIMENTAL
Botulinum toxin type A
Intervention Type
DRUG
Botulinum toxin injection in the horizontal extraocular muscles.
Strabismus surgery
Intervention Type
PROCEDURE
Strabismus surgery on the horizontal extraocular muscles
Surgery-based treatment regimen
First intervention is strabismus surgery. If further treatment is necessary, strabismus surgery can be repeated.
Group Type
ACTIVE_COMPARATOR
Strabismus surgery
Intervention Type
PROCEDURE
Strabismus surgery on the horizontal extraocular muscles
Interventions
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Botulinum toxin type A
Botulinum toxin injection in the horizontal extraocular muscles.
Intervention Type
DRUG
Strabismus surgery
Strabismus surgery on the horizontal extraocular muscles
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
1. Informed consent of trial participant and/or legal representative documented per signature
2. Age \> 1 year and \<17 years
3. Esotropia \> 10Prisms
4. Indication for an intervention (either Botox or surgery) has been made.
5. Any of the following:
* Presence of a secondary strabismus from binocular disruption the cause of the binocular disruption is no longer present
* Decompensated microstrabismus
* Decompensated phoria
* Acute acquired esotropia
6. Positive test of binocular function at any time point in the past, including any of the following
* Titmus test
* Bagolini striated glasses test
* Lang-stereo-test with correct naming of at least one panel
* Good ocular alignment after 6 months of age on at least 2 photographs
2. Age \> 1 year and \<17 years
3. Esotropia \> 10Prisms
4. Indication for an intervention (either Botox or surgery) has been made.
5. Any of the following:
* Presence of a secondary strabismus from binocular disruption the cause of the binocular disruption is no longer present
* Decompensated microstrabismus
* Decompensated phoria
* Acute acquired esotropia
6. Positive test of binocular function at any time point in the past, including any of the following
* Titmus test
* Bagolini striated glasses test
* Lang-stereo-test with correct naming of at least one panel
* Good ocular alignment after 6 months of age on at least 2 photographs
Exclusion Criteria
1. Known hypersensitivity to botulinum toxin
2. Known neuromuscular disorder
3. Known present neurological disorder affecting the central nervous system Including paresis on cranial nerves number 3, 4 and 6
4. Any of the following:
* nystagmus
* dissociated vertical deviation
5. Vertical deviation in any gaze direction greater than 5°
6. Incomitance with more than 5° of difference between the left and right horizontal gaze direction
7. Previous strabismus surgery
8. Previous Botulinum toxin treatment on extraocular muscles
9. Presence of ophthalmic pathologies significantly preventing binocular functions.
A significant alteration of binocular function is assumed if vision is smaller than 0.1 or the visual field has a horizontal diameter of less than 20°.
10. Pregnancy. A negative pregnancy test before randomization is required for all women of child-bearing potential.
11. Preterm children born before 36 weeks of gestation.
2. Known neuromuscular disorder
3. Known present neurological disorder affecting the central nervous system Including paresis on cranial nerves number 3, 4 and 6
4. Any of the following:
* nystagmus
* dissociated vertical deviation
5. Vertical deviation in any gaze direction greater than 5°
6. Incomitance with more than 5° of difference between the left and right horizontal gaze direction
7. Previous strabismus surgery
8. Previous Botulinum toxin treatment on extraocular muscles
9. Presence of ophthalmic pathologies significantly preventing binocular functions.
A significant alteration of binocular function is assumed if vision is smaller than 0.1 or the visual field has a horizontal diameter of less than 20°.
10. Pregnancy. A negative pregnancy test before randomization is required for all women of child-bearing potential.
11. Preterm children born before 36 weeks of gestation.
Minimum Eligible Age
1 Year
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mathias Abegg, Professor
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital
Locations
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Institut Ophtalmologique Sourdille Atlantique
Saint-Herblain, , France
Site Status
Basel University Hopital
Basel, , Switzerland
Site Status
Bern University Hospital
Bern, , Switzerland
Site Status
Geneva University Hospital, HUG
Geneva, , Switzerland
Site Status
Lausanne Univeristy Hospital, CHUV
Lausanne, , Switzerland
Site Status
Luzerner Kantonsspital
Lucerne, , Switzerland
Site Status
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Site Status
University Hospital Zürich
Zurich, , Switzerland
Site Status
Countries
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France
Switzerland
References
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Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. Ophthalmology. 1980 Oct;87(10):1044-9. doi: 10.1016/s0161-6420(80)35127-0.
Reference Type
BACKGROUND
Tejedor J, Rodriguez JM. Early retreatment of infantile esotropia: comparison of reoperation and botulinum toxin. Br J Ophthalmol. 1999 Jul;83(7):783-7. doi: 10.1136/bjo.83.7.783.
Reference Type
BACKGROUND
Tejedor J, Rodriguez JM. Retreatment of children after surgery for acquired esotropia: reoperation versus botulinum injection. Br J Ophthalmol. 1998 Feb;82(2):110-4. doi: 10.1136/bjo.82.2.110.
Reference Type
BACKGROUND
Lee J, Harris S, Cohen J, Cooper K, MacEwen C, Jones S. Results of a prospective randomized trial of botulinum toxin therapy in acute unilateral sixth nerve palsy. J Pediatr Ophthalmol Strabismus. 1994 Sep-Oct;31(5):283-6. doi: 10.3928/0191-3913-19940901-03.
Reference Type
BACKGROUND
Carruthers JD, Kennedy RA, Bagaric D. Botulinum vs adjustable suture surgery in the treatment of horizontal misalignment in adult patients lacking fusion. Arch Ophthalmol. 1990 Oct;108(10):1432-5. doi: 10.1001/archopht.1990.01070120080033.
Reference Type
BACKGROUND
de Alba Campomanes AG, Binenbaum G, Campomanes Eguiarte G. Comparison of botulinum toxin with surgery as primary treatment for infantile esotropia. J AAPOS. 2010 Apr;14(2):111-6. doi: 10.1016/j.jaapos.2009.12.162.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Gursoy H, Basmak H, Sahin A, Yildirim N, Aydin Y, Colak E. Long-term follow-up of bilateral botulinum toxin injections versus bilateral recessions of the medial rectus muscles for treatment of infantile esotropia. J AAPOS. 2012 Jun;16(3):269-73. doi: 10.1016/j.jaapos.2012.01.010.
Reference Type
BACKGROUND
Baggesen K, Arnljot HM. Treatment of congenital esotropia with botulinum toxin type A. Acta Ophthalmol. 2011 Aug;89(5):484-8. doi: 10.1111/j.1755-3768.2009.01737.x. Epub 2009 Oct 30.
Reference Type
BACKGROUND
Campos EC, Schiavi C, Bellusci C. Critical age of botulinum toxin treatment in essential infantile esotropia. J Pediatr Ophthalmol Strabismus. 2000 Nov-Dec;37(6):328-32; quiz 354-5. doi: 10.3928/0191-3913-20001101-05.
Reference Type
BACKGROUND
Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989 Jul;96(7):935-43. doi: 10.1016/s0161-6420(89)32776-x.
Reference Type
BACKGROUND
Kushner BJ, Morton GV. A randomized comparison of surgical procedures for infantile esotropia. Am J Ophthalmol. 1984 Jul 15;98(1):50-61. doi: 10.1016/0002-9394(84)90188-0.
Reference Type
BACKGROUND
Helveston EM, Ellis FD, Schott J, Mitchelson J, Weber JC, Taube S, Miller K. Surgical treatment of congenital esotropia. Am J Ophthalmol. 1983 Aug;96(2):218-28. doi: 10.1016/s0002-9394(14)77790-6.
Reference Type
BACKGROUND
Scheiman M, Ciner E, Gallaway M. Surgical success rates in infantile esotropia. J Am Optom Assoc. 1989 Jan;60(1):22-31.
Reference Type
BACKGROUND
Hatt SR, Leske DA, Liebermann L, Holmes JM. Comparing outcome criteria performance in adult strabismus surgery. Ophthalmology. 2012 Sep;119(9):1930-6. doi: 10.1016/j.ophtha.2012.02.035. Epub 2012 Apr 26.
Reference Type
BACKGROUND
Wan MJ, Mantagos IS, Shah AS, Kazlas M, Hunter DG. Comparison of Botulinum Toxin With Surgery for the Treatment of Acute-Onset Comitant Esotropia in Children. Am J Ophthalmol. 2017 Apr;176:33-39. doi: 10.1016/j.ajo.2016.12.024. Epub 2017 Jan 3.
Reference Type
BACKGROUND
Dysli M, Keller F, Abegg M. Acute onset incomitant image disparity modifies saccadic and vergence eye movements. J Vis. 2015 Mar 18;15(3):12. doi: 10.1167/15.3.12.
Reference Type
BACKGROUND
Dysli M, Abegg M. Gaze-dependent phoria and vergence adaptation. J Vis. 2016;16(3):2. doi: 10.1167/16.3.2.
Reference Type
BACKGROUND
Mahan M, Engel JM. The resurgence of botulinum toxin injection for strabismus in children. Curr Opin Ophthalmol. 2017 Sep;28(5):460-464. doi: 10.1097/ICU.0000000000000408.
Reference Type
BACKGROUND
Pediatric Eye Disease Investigator Group; Christiansen SP, Chandler DL, Lee KA, Superstein R, de Alba Campomanes A, Bothun ED, Morin J, Wallace DK, Kraker RT. Tonic pupil after botulinum toxin-A injection for treatment of esotropia in children. J AAPOS. 2016 Feb;20(1):78-81. doi: 10.1016/j.jaapos.2015.09.011.
Reference Type
BACKGROUND
Pehere N, Jalali S, Mathai A, Naik M, Ramesh K. Inadvertent intraocular injection of botulinum toxin A. J Pediatr Ophthalmol Strabismus. 2011 Jan 25;48 Online:e1-3. doi: 10.3928/01913913-20110118-06.
Reference Type
BACKGROUND
Liu M, Lee HC, Hertle RW, Ho AC. Retinal detachment from inadvertent intraocular injection of botulinum toxin A. Am J Ophthalmol. 2004 Jan;137(1):201-2. doi: 10.1016/s0002-9394(03)00837-7.
Reference Type
BACKGROUND
Bradbury JA, Taylor RH. Severe complications of strabismus surgery. J AAPOS. 2013 Feb;17(1):59-63. doi: 10.1016/j.jaapos.2012.10.016. Epub 2013 Jan 23.
Reference Type
BACKGROUND
Ares C, Superstein R. Retrobulbar hemorrhage following strabismus surgery. J AAPOS. 2006 Dec;10(6):594-5. doi: 10.1016/j.jaapos.2006.04.005. Epub 2006 Oct 2.
Reference Type
BACKGROUND
Rowe FJ, Noonan CP. Botulinum toxin for the treatment of strabismus. Cochrane Database Syst Rev. 2017 Mar 2;3(3):CD006499. doi: 10.1002/14651858.CD006499.pub4.
Reference Type
BACKGROUND
Lyons CJ, Tiffin PA, Oystreck D. Acute acquired comitant esotropia: a prospective study. Eye (Lond). 1999 Oct;13 ( Pt 5):617-20. doi: 10.1038/eye.1999.169.
Reference Type
BACKGROUND
BURIAN HM, MILLER JE. Comitant convergent strabismus with acute onset. Am J Ophthalmol. 1958 Apr;45(4 Pt 2):55-64. doi: 10.1016/0002-9394(58)90223-x. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
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33IC30 173533
Identifier Type: -
Identifier Source: org_study_id
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