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Effect of Percutaneous Botulinum Toxin A Injection on Natural Course of Upper Lid Retraction in Thyroid Eye Disease

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ClinicalTrials.gov Identifier: NCT00370734
Recruitment Status : Unknown
Verified February 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 1, 2006
Last Update Posted : February 27, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . We are going to compare the natural course of the upper lid retraction with injection of botulinum toxin A injection to upper lid percutaneously.

Condition or disease Intervention/treatment Phase
Eye Diseases Drug: Botulinum toxin A injection Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2005
Estimated Study Completion Date : February 2007

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy

Exclusion Criteria:

  • patients in non active phase
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT00370734


Contacts
Contact: Babak Babsharif, MD +98 21 22585952 labbafi@hotmail.com

Locations
Iran, Islamic Republic of
Babak Babsharif, MD Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Babak Babsharif, MD    +98 21 22585952    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Babak Babsharif, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
More Information

ClinicalTrials.gov Identifier: NCT00370734     History of Changes
Other Study ID Numbers: 8375
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
botulinum toxin
thyroid eye disease
lid retraction

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
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