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

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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Additional Information:

The page shows the summaries of Unicamp Theses on Botulinum Toxin 

Publications:

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.

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, Topaloğlu 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.

• 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
• 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; 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