Status:
COMPLETED
Botox Instead of Strabismus Surgery (BISS)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Acquired Esotropia
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
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 treatmen...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Informed consent of trial participant and/or legal representative documented per signature
- Age \> 1 year and \<17 years
- Esotropia \> 10Prisms
- Indication for an intervention (either Botox or surgery) has been made.
- 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
- 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
- Known hypersensitivity to botulinum toxin
- Known neuromuscular disorder
- Known present neurological disorder affecting the central nervous system Including paresis on cranial nerves number 3, 4 and 6
- Any of the following:
- nystagmus
- dissociated vertical deviation
- Vertical deviation in any gaze direction greater than 5°
- Incomitance with more than 5° of difference between the left and right horizontal gaze direction
- Previous strabismus surgery
- Previous Botulinum toxin treatment on extraocular muscles
- 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°.
- Pregnancy. A negative pregnancy test before randomization is required for all women of child-bearing potential.
- Preterm children born before 36 weeks of gestation.
Key Trial Info
Start Date :
August 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03459092
Start Date
August 16 2018
End Date
July 31 2023
Last Update
November 7 2023
Active Locations (8)
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1
Institut Ophtalmologique Sourdille Atlantique
Saint-Herblain, France
2
Basel University Hopital
Basel, Switzerland
3
Bern University Hospital
Bern, Switzerland
4
Geneva University Hospital, HUG
Geneva, Switzerland