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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014