- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460355
Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
October 25, 2011 updated by: Nilza Minguini, University of Campinas, Brazil
Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
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.
Study Overview
Status
Completed
Intervention / 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
Interventional
Enrollment (Actual)
23
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Campinas, São Paulo, Brazil, 13084-971
- State University of Campinas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults with large angle horizontal strabismus
Exclusion Criteria:
- oblique muscle disfunction
- previous strabismus surgery
- dissociated vertical deviation
- paretic or restrictive deviation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
injection of 5U in 0.1ml of saline solution will be given to the recessed muscle
Other Names:
|
Placebo Comparator: Saline solution plus surgery
Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure
|
injection of 0,1ml of saline solution will be given to the recessed muscle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of decrease of the initial angle of strabismus
Time Frame: 6 to 12 months
|
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.
|
6 to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
frequency of induced blepharoptosis
Time Frame: From the first to the last post operative day of follow up
|
The presence of induced blepharoptosis was detected by simple inspection and was reported as positive or negative.
|
From the first to the last post operative day of follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nilza Minguini, MD, PhD, University of Campinas, Brazil
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
October 16, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (Estimate)
October 26, 2011
Study Record Updates
Last Update Posted (Estimate)
October 26, 2011
Last Update Submitted That Met QC Criteria
October 25, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Eye Diseases
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Strabismus
- Exotropia
- Esotropia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- Unicamp-CEP- 427/2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exotropia
-
Yonsei UniversityCompletedExotropia or Intermittent ExotropiaKorea, Republic of
-
Nunaps IncRecruitingIntermittent ExotropiaKorea, Republic of
-
Retina Foundation of the SouthwestRecruiting
-
Singapore National Eye CentreTerminatedIntermittent ExotropiaSingapore
-
Indiana University School of MedicineTerminatedIntermittent ExotropiaUnited States
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); Pediatric Eye Disease Investigator GroupCompletedIntermittent ExotropiaUnited States
-
Samsung Medical CenterCompletedIntermittent Exotropia
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); Pediatric Eye Disease Investigator GroupRecruitingIntermittent ExotropiaUnited States
-
Sun Yat-sen UniversitySalus UniversityNot yet recruitingIntermittent Exotropia
-
Southern California College of Optometry at Marshall...University of Alabama at Birmingham; Stanford University; Ohio State University; Case Western Reserve University and other collaboratorsRecruiting
Clinical Trials on Botulinum Toxin Type A
-
AllerganTerminatedOveractive BladderSerbia, Turkey, Greece, Egypt, Lebanon, India
-
Daewoong Pharmaceutical Co. LTD.Completed
-
AllerganCompletedOveractive BladderPortugal, South Africa, Netherlands, Canada, Singapore, Brazil, United States, Taiwan, Italy, United Kingdom, France, Spain
-
AllerganCompletedOveractive BladderUnited Kingdom, Belgium, New Zealand, France, Russian Federation, Czech Republic, United States, Germany, Austria, Poland, Slovakia, Ukraine, Canada, Australia
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar RhytidesUnited States
-
Brazilan Center for Studies in DermatologyCompletedWrinkles in Frontal AreaBrazil
-
HugelCompletedBenign Masseteric HypertrophyKorea, Republic of
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar Rhytides | Frown Lines Between the EyebrowsUnited States
-
Medy-ToxCompletedCervical Dystonia
-
Seton Healthcare FamilyCompleted