Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nilza Minguini, University of Campinas, Brazil

ClinicalTrials.gov Identifier:

NCT01460355

First received: October 16, 2011

Last updated: October 25, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 16, 2011

Last Updated Date

October 25, 2011

Start Date ^ICMJE

September 2006

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

percentage of decrease of the initial angle of strabismus [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]

The percentages of decrease of the initial angle of strabismus were accessed by subtracting the final deviation of the initial deviation, dividing the result by the initial deviation and multiplying it by 100.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01460355 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

frequency of induced blepharoptosis [ Time Frame: From the first to the last post operative day of follow up ] [ Designated as safety issue: No ]

The presence of induced blepharoptosis was detected by simple inspection and was reported as positive or negative.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone

Official Title ^ICMJE

Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study

Brief Summary

Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only conventional recess-resect surgery. The patients were randomly located in one of the groups. The angles of horizontal deviation were compared between the groups before and six months after treatment.

Detailed Description

Patients underwent recess/resection surgery on the non-fixating eye using conventional technique under local anesthesia. The extent of surgery was determined based on our usual amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in 0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Esotropia
Exotropia

Intervention ^ICMJE

Drug: Botulinum Toxin Type A
injection of 5U in 0.1ml of saline solution will be given to the recessed muscle

Other Name: BTA
Drug: saline solution
injection of 0,1ml of saline solution will be given to the recessed muscle

Other Name: saline

Study Arm (s)

Active Comparator: Botulinum toxin plus surgery
Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery

Intervention: Drug: Botulinum Toxin Type A
Placebo Comparator: Saline solution plus surgery
Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure

Intervention: Drug: saline solution

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adults with large angle horizontal strabismus

Exclusion Criteria:

oblique muscle disfunction
previous strabismus surgery
dissociated vertical deviation
paretic or restrictive deviation

Gender

Both

Ages

20 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01460355

Other Study ID Numbers ^ICMJE

Unicamp-CEP- 427/2006

Has Data Monitoring Committee

Responsible Party

Nilza Minguini, University of Campinas, Brazil

Study Sponsor ^ICMJE

University of Campinas, Brazil

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nilza Minguini, MD, PhD

University of Campinas, Brazil

Information Provided By

University of Campinas, Brazil

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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