Completed

Botulinum Toxin Type A for Keratoconus

What is being tested

Subcutaneous injection of botulinum toxin type A

+ Botulinum Toxin Type A

ProcedureDrug

Who is being recruted

Corneal Diseases

+ Eye Diseases

+ Keratoconus

From 10 to 40 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorFederal University of São Paulo

Last updated: October 21, 2014

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01691651

Principal SponsorFederal University of São Paulo

Last updated: October 21, 2014

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Corneal DiseasesEye DiseasesKeratoconus

Criteria

5 inclusion criteria required to participate

age between 10-40 years

best-corrected visual acuity measurable at refraction test

good health

patients with documented keratoconus

Show More Criteria

6 exclusion criteria prevent from participating

concurrent corneal infection and other ocular diseases that modified the visual acuity

known allergy to botulinum toxin

only one functional eye

poor collaboration for performing the examinations and the procedure

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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.

Group II

No Intervention

The group that will not be subjected to any intervention.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Federal University of São Paulo, Department of Ophthalmology

São Paulo, BrazilOpen Federal University of São Paulo, Department of Ophthalmology in Google Maps

CompletedOne Study Center