Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- percentage of decrease of the initial angle of strabismus
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults with large angle horizontal strabismus
Exclusion Criteria
- •oblique muscle disfunction
- •previous strabismus surgery
- •dissociated vertical deviation
- •paretic or restrictive deviation
Arms & Interventions
Botulinum toxin plus surgery
Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery
Intervention: Botulinum Toxin Type A (Drug)
Saline solution plus surgery
Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure
Intervention: saline solution (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- frequency of induced blepharoptosis(From the first to the last post operative day of follow up)
Investigators
Nilza Minguini
MD, PhD
University of Campinas, Brazil