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Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01272414
Recruitment Status : Withdrawn (lack of funding)
First Posted : January 7, 2011
Last Update Posted : June 3, 2015
Information provided by:
University of Toronto

Brief Summary:
Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.

Condition or disease Intervention/treatment Phase
Graves Ophthalmopathy Drug: Botulinum Toxin Type A Drug: Saline injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BoTox Treatment
Subjects receive BoTox injection to levator complex
Drug: Botulinum Toxin Type A
2-12 units in weekly 2u doses to effect
Other Name: BoTox

Placebo Comparator: Saline injection
Saline injection to levator complex
Drug: Saline injection
Injection of 0.4cc 0.9% normal saline
Other Name: Placebo

Primary Outcome Measures :
  1. Reduction in upper lid retraction (in mm) [ Time Frame: 4 month ]

Secondary Outcome Measures :
  1. Subjective improvement in lid retraction related dry eye symptoms [ Time Frame: 4 months ]
    ocular surface disease index score

  2. Subjective improvement in lid retraction related cosmesis [ Time Frame: 4 months ]
    Graves Orbitopathy quality of life score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Active stage thyroid orbitopathy, as determined by symptom onset of under 6 months.
  • Upper eyelid retraction of 1mm or greater.
  • Complaining of either significant ocular symptoms (despite appropriate use of ocular lubricants), or bothered by the cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

  • Less than 18 years of age
  • Age over 65 years
  • Pregnant or nursing
  • Known peripheral neuropathy or neuromuscular junction disorder
  • Demonstrated allergy to BoTox
  • Current infection over the injection site
  • Are currently taking any of the following medications: aminoglycosides, penicillamine, quinine, and calcium channel blockers.
  • Previous or concurrent prednisone therapy
  • Undergone previous upper eyelid surgery
  • Severe vision threatening TO

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01272414

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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
University of Toronto
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Principal Investigator: Daniel B Rootman, MSc MD University of Toronto
Principal Investigator: Nancy Tucker, MD FRCSC University of Toronto

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Responsible Party: Dr Nancy Tucker, MD FRCSC, University of Toronto Identifier: NCT01272414     History of Changes
Other Study ID Numbers: 10-0261-A
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: December 2010
Keywords provided by University of Toronto:
Eyelid retraction
Botulinum Toxins
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents