Botox Instead of Strabismus Surgery (BISS) (BISS)
Acquired Esotropia
About this trial
This is an interventional treatment trial for Acquired Esotropia focused on measuring Botulinum toxin, strabismus surgery, binocular vision
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Institut Ophtalmologique Sourdille Atlantique
- Basel University Hopital
- Bern University Hospital
- Geneva University Hospital, HUG
- Lausanne Univeristy Hospital, CHUV
- Luzerner Kantonsspital
- Kantonsspital St. Gallen
- University Hospital Zürich
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Botox-based treatment regimen
Surgery-based treatment regimen
First intervention is a Botulinum toxin type A injection. If further treatment is necessary, strabismus surgery can be performed.
First intervention is strabismus surgery. If further treatment is necessary, strabismus surgery can be repeated.