Clinical Trial: Botulinum Toxin A for the Treatment of Keratoconus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Botulinum Toxin Type A for Keratoconus

Brief 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 Summary: 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.
Sponsor: Federal University of São Paulo

Current Primary Outcome: Measurement of the palpebral fissure [ Time Frame: Eighteen months. ]

We will evaluate the change in palpebral fissure (unit of measure=millimetre)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.


Original Primary Outcome: Measurement of the palpebral fissure [ Time Frame: One year ]

We will evaluate the change in palpebral fissure (unit of measure=millimetre)by 1 year.These time points will be included:baseline, 3, 6, and 12 months.


Current Secondary Outcome: Corneal topography [ Time Frame: Eighteen months. ]

We will evaluate corneal topography [flattest keratometry, steepest keratometry and average keratometry(unit of measure=diopters)]by 18 months.These time points will be included:baseline, 3, 6,12 and 18 months.


Original Secondary Outcome: Corneal topography [ Time Frame: One year. ]

We will evaluate corneal topography [flattest keratometry, steepest keratometry and average keratometry(unit of measure=diopters)]by 1 year.These time points will be included:baseline, 3, 6, and 12 months.


Information By: Federal University of São Paulo

Dates:
Date Received: September 18, 2012
Date Started: September 2012
Date Completion:
Last Updated: October 18, 2014
Last Verified: October 2014