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OpenTrials
Completed

NCT Number: NCT01460355

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

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.

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Key information

Conditions

Esotropia Blepharoptosis Cranial Nerve Diseases Exotropia Eye Diseases Eyelid Diseases Nervous System Diseases Ocular Motility Disorders Strabismus

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

State University of Campinas

Campinas, São Paulo, 13084-971, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults with large angle horizontal strabismus

Exclusion criteria

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

Treatment and study plan

Botulinum Toxin Type A

Drug

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

Other names: BTA

Saline Solution

Drug

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

Other names: saline

Primary outcomes

  1. 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

  1. frequency of induced blepharoptosis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Oct 26, 2011
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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