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

Purpose

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	Intervention	Phase
Esotropia Exotropia	Drug: Botulinum Toxin Type A Drug: saline solution	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:

percentage of decrease of the initial angle of strabismus [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: From the first to the last post operative day of follow up ] [ Designated as safety issue: No ]
The presence of induced blepharoptosis was detected by simple inspection and was reported as positive or negative.

Enrollment:	23
Study Start Date:	September 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

The page shows the summaries of Unicamp Theses on Botulinum Toxin This link exits the ClinicalTrials.gov site

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, Topalo?lu 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 History of Changes
Other Study ID Numbers:	Unicamp-CEP- 427/2006
Study First Received:	October 16, 2011
Last Updated:	October 25, 2011
Health Authority:	Brazil: Ministry of Health

Keywords provided by University of Campinas, Brazil:

strabismus surgery
botulinum toxin
esotropia
exotropia
blepharoptosis

Additional relevant MeSH terms:

Esotropia
Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Botulinum Toxins, Type A

Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013