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Botulinum Toxin A for the Treatment of Keratoconus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Adimara da Candelaria Renesto, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01691651
First received: September 18, 2012
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Botulinum Toxin A for the Treatment of Keratoconus

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Measurement of the palpebral fissure [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Corneal topography [ Time Frame: One year. ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Aberrometer [ Time Frame: One year. ] [ Designated as safety issue: No ]
    We will evaluate the aberrometer (unit of measure=um[micra])by 1 year.These time points will be included:baseline, 3, 6, and 12 months.


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 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 one point 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 one point 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 one point 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 type A botulinum toxin will be performed at one point 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 one year.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

Ages Eligible for Study:   10 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Pubmed comprises citations for biomedical literature from MEDLINE, life science journals, and online books.  This link exits the ClinicalTrials.gov site

Publications:

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
Study First Received: September 18, 2012
Last Updated: April 8, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Keratoconus
Tetanus toxin

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013