Botulinum Toxin A for the Treatment of Keratoconus

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)

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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.