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Botulinum Toxin A for the Treatment of Keratoconus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691651
First Posted: September 25, 2012
Last Update Posted: October 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adimara da Candelaria Renesto, Federal University of São Paulo
  Purpose
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.

Condition Intervention
Keratoconus Procedure: Subcutaneous injection of botulinum toxin type A Drug: Botulinum Toxin Type A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A for Keratoconus

Resource links provided by NLM:


Further study details as provided by Adimara da Candelaria Renesto, Federal University of São Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Corrected visual acuity [ Time Frame: Eighteen months. ]
    We will evaluate the corrected visual acuity (unit of measure=logMAR)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.


Enrollment: 40
Study Start Date: September 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botulinum toxin type A
The group that will be subjected to the injection of botulinum toxin (subcutaneous injection of botulinum toxin type A).Subcutaneous botulinum toxin A injection will be performed in this group, (2.5 units per point application), at two points in a nasal and temporal extent of the orbicularis muscle.
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.
Other Name: Botox (Allergan)
No Intervention: Control
The group that will not be subjected to any intervention.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691651


Locations
Brazil
Federal University of São Paulo, Department of Ophthalmology
São Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Adimara C Renesto, MD Federal University of São Paulo
Study Chair: Teissy H Osaki, MD Federal University of São Paulo
Study Chair: Midori H Osaki, MD Federal University of São Paulo
Study Director: Mauro Q Campos, MD Federal University of São Paulo
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adimara da Candelaria Renesto, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01691651     History of Changes
Other Study ID Numbers: RECUNIFESP-87051
First Submitted: September 18, 2012
First Posted: September 25, 2012
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Adimara da Candelaria Renesto, Federal University of São Paulo:
Keratoconus
Tetanus toxin

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents