Clinical trial NCT01691651: Botulinum Toxin A for the Treatment of Keratoconus
Official title: Botulinum Toxin Type A for Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus
Tetanus toxin
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* patients with documented keratoconus
* best-corrected visual acuity measurable at refraction test
* age between 10-40 years
* good health
* understand the procedure and its limitations

Exclusion Criteria:

* only one functional eye
* previous ocular surgery
* concurrent corneal infection and other ocular diseases that modified the visual acuity
* known allergy to botulinum toxin
* pregnancy
* poor collaboration for performing the examinations and the procedure

Primary outcomes:
measure: Measurement of the palpebral fissure
timeFrame: Eighteen months.
Secondary outcomes:
measure: Corneal topography
timeFrame: Eighteen months.
Other outcomes:
measure: Corrected visual acuity
timeFrame: Eighteen months.
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo, Department of Ophthalmology
Study officials:
affiliation: Federal University of São Paulo
name: Adimara C Renesto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Teissy H Osaki, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Midori H Osaki, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Mauro Q Campos, MD
role: STUDY_DIRECTOR
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citation: Renesto ADC, Osaki TH, Osaki MH, Hirai FE, Campos M. Keratoconus progression is not inhibited by reducing eyelid muscular force with botulinum toxin A treatment: a randomized trial. Arq Bras Oftalmol. 2017 Mar-Apr;80(2):88-92. doi: 10.5935/0004-2749.20170022.