EUCTR2012-005068-82-NL
Active, not recruiting
Not Applicable
An alternative approach for treatment of infantile esotropia with botulinum toxin A. - Botox in infantile esotropia.
The Rotterdam Eye Hospital0 sites40 target enrollmentNovember 19, 2012
DrugsBotox
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Rotterdam Eye Hospital
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Infantile esotropia; age \< 4 years,
- •\- No known/established neurological disease.
- •\- Onset of esotropia before 6 months without paralytic component.
- •\- No vertical deviation (no upshoots).
- •\- Non\-accommodative (less than 3D spherical equivalent hyperopia).
- •\- Up to 40 ? esotropia.
- •\- Free alternators.
- •\- Difference in refraction between both eyes \= 1\.5 D.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
Exclusion Criteria
- •\- Previous strabismus surgery.
- •\- Retinal disease.
- •\- Any medical condition that would preclude general anesthesia with sevoflurane.
Outcomes
Primary Outcomes
Not specified
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