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

Phase 4

Completed

• Conditions: Esotropia; Exotropia
• Interventions: Drug: saline solution; Drug: Botulinum Toxin Type A

• Registration Number: NCT01460355
• Lead Sponsor: University of Campinas, Brazil

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 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 Timeline

• Study Start: 2006-09
• Primary Completion: 2007-06
• Study Completion: 2008-06
• Status Verified: 2011-10
• Study First Submitted: 2011-10-16
• Study First Submitted QC: 2011-10-25
• Last Update Submitted: 2011-10-25
• Study First Posted: 2011-10-26
• Last Update Posted: 2011-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• adults with large angle horizontal strabismus

Exclusion Criteria

• oblique muscle disfunction
• previous strabismus surgery
• dissociated vertical deviation
• paretic or restrictive deviation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline solution plus surgery	saline solution	Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure
Botulinum toxin plus surgery	Botulinum Toxin Type A	Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery

Primary Outcome Measures

Name	Time	Method
percentage of decrease of the initial angle of strabismus	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

Name	Time	Method
frequency of induced blepharoptosis	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.

Trial Locations

Locations (1)

State University of Campinas; 🇧🇷 Campinas, São Paulo, Brazil