An alternative approach for treatment of infantile esotropia with botulinum toxin A.
Suspended
- Conditions
- Infantile esotropia.
- Registration Number
- NL-OMON24276
- Lead Sponsor
- The Rotterdam Eye Hospital (REH)PO Box 70030NL-3000 LM Rotterdamtel: 010 4017777
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. No known/established neurological disease;
2. History of orthotropia;
Exclusion Criteria
1. Previous strabismus surgery;
2. Retinal disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of successful motor alignment at six months. This will be measured with a synoptophore. Successful alignment is defined as ¡Ü ¡À10 prism diopters of residual esotropia at 6 months.
- Secondary Outcome Measures
Name Time Method 1. Degree of esotropia (prism diopters);<br /><br>2. Time of onset esotropia;<br /><br>3. Measurement of binocularity: alignment & fusion;<br /><br>4. Percentages and duration of ptosis and exotropia (temporary side effects of botulinum injection);<br /><br>5. Percentages of reinjection and additional alignment surgery;<br /><br>6. BCVA at each visit and amblyopia;<br /><br>7. Occurrence of vertical disturbances of ocular motility;<br /><br>8. Adverse events.