Skip to main content
OpenTrials
Completed

NCT Number: NCT01691651

Botulinum Toxin A for the Treatment of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

10 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo, Department of Ophthalmology

São Paulo, 04023-062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcutaneous injection of botulinum toxin type A

Procedure

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.

Botulinum Toxin Type A

Drug

2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.

Other names: Botox (Allergan)

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Botulinum Toxin Type A for Keratoconus

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 25, 2012
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.