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

Exotropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460355
• Other study ID #: Unicamp-CEP- 427/2006
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2011
• Last updated: October 25, 2011
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2011
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esotropia
• Exotropia
• Strabismus

Intervention

Drug:
• Botulinum Toxin Type A
injection of 5U in 0.1ml of saline solution will be given to the recessed muscle
• saline solution
injection of 0,1ml of saline solution will be given to the recessed muscle

Locations

Country	Name	City	State
Brazil	State University of Campinas	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

Ozkan SB, Topaloglu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of decrease of the initial angle of strabismus	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.	6 to 12 months	No
Secondary	frequency of induced blepharoptosis	The presence of induced blepharoptosis was detected by simple inspection and was reported as positive or negative.	From the first to the last post operative day of follow up	No

External Links

•   The page shows the summaries of Unicamp Theses on Botulinum Toxin