Botulinum Toxin A for the Treatment of Keratoconus

F

Federal University of São Paulo

Status

Completed

Conditions

Keratoconus

Treatments

Procedure: Subcutaneous injection of botulinum toxin type A
Drug: Botulinum Toxin Type A

Study type

Interventional

Funder types

Other

Identifiers

NCT01691651
RECUNIFESP-87051

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

10 to 40 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Botulinum toxin type A
Active Comparator group
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.
Treatment:
Drug: Botulinum Toxin Type A
Procedure: Subcutaneous injection of botulinum toxin type A
Control
No Intervention group
Description:
The group that will not be subjected to any intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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