Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT03459092
Eligibility Criteria:
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
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT03459092
Study Brief:
Protocol Section:
NCT03459092