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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01460355

Enrollment

Registered

2011-10-26

Start date

2006-09-30

Completion date

2008-06-30

Last updated

2011-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esotropia, Exotropia

Keywords

strabismus surgery, botulinum toxin, esotropia, exotropia, blepharoptosis

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.

Interventions

DRUGBotulinum Toxin Type A

injection of 5U in 0.1ml of saline solution will be given to the recessed muscle

DRUGsaline solution

injection of 0,1ml of saline solution will be given to the recessed muscle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

* adults with large angle horizontal strabismus

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026