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

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ClinicalTrials.gov Identifier: NCT01460355
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : October 26, 2011
Sponsor:
Information provided by (Responsible Party):
Nilza Minguini, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Esotropia Exotropia Drug: Botulinum Toxin Type A Drug: saline solution Phase 4

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  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
Study Start Date : September 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2008


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
Drug: Botulinum Toxin Type A
injection of 5U in 0.1ml of saline solution will be given to the recessed muscle
Other Name: BTA
Placebo Comparator: Saline solution plus surgery
Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure
Drug: saline solution
injection of 0,1ml of saline solution will be given to the recessed muscle
Other Name: saline



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults with large angle horizontal strabismus

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460355


Locations
Brazil
State University of Campinas
Campinas, São Paulo, Brazil, 13084-971
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Nilza Minguini, MD, PhD University of Campinas, Brazil

Additional Information:
Publications:
Responsible Party: Nilza Minguini, MD, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01460355     History of Changes
Other Study ID Numbers: Unicamp-CEP- 427/2006
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Keywords provided by Nilza Minguini, University of Campinas, Brazil:
strabismus surgery
botulinum toxin
esotropia
exotropia
blepharoptosis

Additional relevant MeSH terms:
Strabismus
Exotropia
Esotropia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Pharmaceutical Solutions
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents