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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study

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.

Detailed Summary: 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.
Sponsor: University of Campinas, Brazil

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: University of Campinas, Brazil

Dates:
Date Received: October 16, 2011
Date Started: September 2006
Date Completion:
Last Updated: October 25, 2011
Last Verified: October 2011