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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.
Federal University of São Paulo, Department of Ophthalmology
São Paulo, São Paulo, Brazil
Measurement of the palpebral fissure
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.
Time frame: Eighteen months.
Corneal topography
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.
Time frame: Eighteen months.
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