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

NCT ID: NCT01460355

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Esotropia Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Botulinum toxin plus surgery

Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type DRUG

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

Saline solution plus surgery

Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

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

Interventions

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Botulinum Toxin Type A

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

Intervention Type DRUG

saline solution

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

Intervention Type DRUG

Other Intervention Names

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BTA saline

Eligibility Criteria

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Inclusion Criteria

* adults with large angle horizontal strabismus

Exclusion Criteria

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

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Nilza Minguini

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilza Minguini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

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State University of Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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. doi: 10.1016/s1091-8531(98)90004-0.

Reference Type BACKGROUND
PMID: 10532749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15828866 (View on PubMed)

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. doi: 10.1016/j.jaapos.2005.11.011.

Reference Type BACKGROUND
PMID: 16678746 (View on PubMed)

Related Links

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http://www.bibliotecadigital.unicamp.br

The page shows the summaries of Unicamp Theses on Botulinum Toxin

Other Identifiers

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Unicamp-CEP- 427/2006

Identifier Type: -

Identifier Source: org_study_id