NCT01460355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

9 months

First QC Date

October 16, 2011

Last Update Submit

October 25, 2011

Conditions

EsotropiaExotropia

Keywords

strabismus surgerybotulinum toxinesotropiaexotropiablepharoptosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • frequency of induced blepharoptosis

    From the first to the last post operative day of follow up

Study Arms (2)

Botulinum toxin plus surgery

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin Type A

Saline solution plus surgery

PLACEBO COMPARATOR

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

Drug: saline solution

Interventions

Botulinum Toxin Type ADRUG

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

Also known as: BTA
Botulinum toxin plus surgery
saline solutionDRUG

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

Also known as: saline
Saline solution plus surgery

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults with large angle horizontal strabismus

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Campinas

Campinas, São Paulo, 13084-971, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 10532749BACKGROUND

  • 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.

    PMID: 15828866BACKGROUND

  • 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.

    PMID: 16678746BACKGROUND

Related Links

MeSH Terms

Conditions

EsotropiaExotropiaBlepharoptosis

Interventions

Botulinum Toxins, Type ASaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye DiseasesEyelid Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Nilza Minguini, MD, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 16, 2011

First Posted

October 26, 2011

Study Start

September 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations

BR(1)