Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
Primary Purpose
Esotropia, Exotropia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Botulinum Toxin Type A
saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Esotropia focused on measuring strabismus surgery, botulinum toxin, esotropia, exotropia, blepharoptosis
Eligibility Criteria
Inclusion Criteria:
- adults with large angle horizontal strabismus
Exclusion Criteria:
- oblique muscle disfunction
- previous strabismus surgery
- dissociated vertical deviation
- paretic or restrictive deviation
Sites / Locations
- State University of Campinas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Botulinum toxin plus surgery
Saline solution plus surgery
Arm Description
Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery
Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure
Outcomes
Primary Outcome Measures
percentage of decrease of the initial angle of strabismus
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.
Secondary Outcome Measures
frequency of induced blepharoptosis
The presence of induced blepharoptosis was detected by simple inspection and was reported as positive or negative.
Full Information
NCT ID
NCT01460355
First Posted
October 16, 2011
Last Updated
October 25, 2011
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01460355
Brief Title
Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
Official Title
Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esotropia, Exotropia
Keywords
strabismus surgery, botulinum toxin, esotropia, exotropia, blepharoptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin plus surgery
Arm Type
Active Comparator
Arm Description
Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery
Arm Title
Saline solution plus surgery
Arm Type
Placebo Comparator
Arm Description
Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BTA
Intervention Description
injection of 5U in 0.1ml of saline solution will be given to the recessed muscle
Intervention Type
Drug
Intervention Name(s)
saline solution
Other Intervention Name(s)
saline
Intervention Description
injection of 0,1ml of saline solution will be given to the recessed muscle
Primary Outcome Measure Information:
Title
percentage of decrease of the initial angle of strabismus
Description
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.
Time Frame
6 to 12 months
Secondary Outcome Measure Information:
Title
frequency of induced blepharoptosis
Description
The presence of induced blepharoptosis was detected by simple inspection and was reported as positive or negative.
Time Frame
From the first to the last post operative day of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with large angle horizontal strabismus
Exclusion Criteria:
oblique muscle disfunction
previous strabismus surgery
dissociated vertical deviation
paretic or restrictive deviation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilza Minguini, MD, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13084-971
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
10532749
Citation
Owens PL, Strominger MB, Rubin PA, Veronneau-Troutman S. Large-angle exotropia corrected by intraoperative botulinum toxin A and monocular recession resection surgery. J AAPOS. 1998 Jun;2(3):144-6. doi: 10.1016/s1091-8531(98)90004-0.
Results Reference
background
PubMed Identifier
15828866
Citation
Khan AO. Two horizontal rectus eye muscle surgery combined with botulinum toxin for the treatment of very large angle esotropia. A pilot study. Binocul Vis Strabismus Q. 2005;20(1):15-20.
Results Reference
background
PubMed Identifier
16678746
Citation
Ozkan SB, Topaloglu A, Aydin S. The role of botulinum toxin A in augmentation of the effect of recession and/or resection surgery. J AAPOS. 2006 Apr;10(2):124-7. doi: 10.1016/j.jaapos.2005.11.011.
Results Reference
background
Links:
URL
http://www.bibliotecadigital.unicamp.br
Description
The page shows the summaries of Unicamp Theses on Botulinum Toxin
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Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
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