Botulinum Toxin A for the Treatment of Keratoconus

October 18, 2014 updated by: Adimara da Candelaria Renesto, Federal University of São Paulo

Botulinum Toxin Type A for Keratoconus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04023-062
        • Federal University of São Paulo, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Botox (Allergan)
NO_INTERVENTION: Control
The group that will not be subjected to any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Eighteen months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Eighteen months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Eighteen months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (ESTIMATE)

September 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 18, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECUNIFESP-87051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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