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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nilza Minguini, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01460355
First received: October 16, 2011
Last updated: October 25, 2011
Last verified: October 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
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:
Strabismus
Esotropia
Exotropia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Pharmaceutical Solutions
Botulinum Toxins
Botulinum Toxins, Type A
Therapeutic Uses
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014