Botulinum Toxin A for the Treatment of Keratoconus

Botulinum Toxin Type A for Keratoconus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01691651

Enrollment

Registered

2012-09-25

Start date

2012-09-30

Completion date

2014-10-31

Last updated

2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus, Tetanus toxin

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.

Interventions

PROCEDURESubcutaneous 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.

DRUGBotulinum Toxin Type A

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Measurement of the palpebral fissure	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

Measure	Time frame	Description
Corneal topography	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

Measure	Time frame	Description
Corrected visual acuity	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026