Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- Ozkan SB, Topaloğlu 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.
- Unicamp-CEP- 427/2006