NCT01691651

Botulinum Toxin A for the Treatment of Keratoconus

Botulinum Toxin Type A for Keratoconus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 10 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to associate the use of botulinum toxin type A for patients with keratoconus to demonstrate that tension eyelid has an important role in disease progression.

Detailed description

Subcutaneous injection of botulinum toxin type A will be performed at two points in a nasal and temporal extent of the orbicularis muscle of a group of patients with keratoconus (Botulinum toxin A group).The idea is to evaluate the change in palpebral fissure in patients from group botulinum toxin A over a period of 18 months.The measurements of the palpebral fissure will be performed by the Image J (version 1.34s) program, developed by the National Institutes of Health (USA).The unit of measure is the millimetre.The patients of the botulinum toxin A group will be compared with a control group, without any intervention.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	Subcutaneous injection of botulinum toxin type A	Subcutaneous injection of botulinum toxin type A (2.5 units per application point) at two points in a nasal and temporal extent of the orbicularis muscle will be performed in the Botulinum toxin type A group.
DRUG	Botulinum Toxin Type A	2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-09-25
• Last updated: 2014-10-21

Locations

1 site across 1 country: Brazil