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Botulinum Toxin A for the Treatment of Keratoconus

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Subcutaneous injection of botulinum toxin type A
Botulinum Toxin Type A
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Tetanus toxin

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Botulinum toxin type A

Control

Arm Description

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.

The group that will not be subjected to any intervention.

Outcomes

Primary Outcome Measures

Measurement of the palpebral fissure
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
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.

Full Information

First Posted
September 18, 2012
Last Updated
October 18, 2014
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01691651
Brief Title
Botulinum Toxin A for the Treatment of Keratoconus
Official Title
Botulinum Toxin Type A for Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Tetanus toxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin type A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The group that will not be subjected to any intervention.
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous injection of botulinum toxin type A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botox (Allergan)
Intervention Description
2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.
Primary Outcome Measure Information:
Title
Measurement of the palpebral fissure
Description
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.
Time Frame
Eighteen months.
Secondary Outcome Measure Information:
Title
Corneal topography
Description
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.
Time Frame
Eighteen months.
Other Pre-specified Outcome Measures:
Title
Corrected visual acuity
Description
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.
Time Frame
Eighteen months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adimara C Renesto, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teissy H Osaki, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Midori H Osaki, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mauro Q Campos, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of São Paulo, Department of Ophthalmology
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

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Links:
URL
http://pubmed.gov
Description
Pubmed comprises citations for biomedical literature from MEDLINE, life science journals, and online books.

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Botulinum Toxin A for the Treatment of Keratoconus

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