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
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Condition or disease | Intervention/treatment | Phase |
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Esotropia Exotropia | Drug: Botulinum Toxin Type A Drug: saline solution | Phase 4 |
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
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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
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Drug: saline solution
injection of 0,1ml of saline solution will be given to the recessed muscle
Other Name: saline |
- 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.
- 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 |
Inclusion Criteria:
- adults with large angle horizontal strabismus
Exclusion Criteria:
- oblique muscle disfunction
- previous strabismus surgery
- dissociated vertical deviation
- paretic or restrictive deviation

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
Brazil | |
State University of Campinas | |
Campinas, São Paulo, Brazil, 13084-971 |
Principal Investigator: | Nilza Minguini, MD, PhD | University of Campinas, Brazil |
Publications:
Responsible Party: | Nilza Minguini, MD, PhD, University of Campinas, Brazil |
ClinicalTrials.gov Identifier: | NCT01460355 |
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 |
strabismus surgery botulinum toxin esotropia exotropia blepharoptosis |
Strabismus Exotropia Esotropia Ocular Motility Disorders Cranial Nerve Diseases Nervous System Diseases Eye Diseases Botulinum Toxins Botulinum Toxins, Type A |
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 |