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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Shaheed Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370734
First received: August 31, 2006
Last updated: February 26, 2007
Last verified: February 2007
History of Changes
  Purpose

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 Intervention Phase
Eye Diseases
 Drug: Botulinum toxin A injection
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Estimated Enrollment: 50
Study Start Date: May 2005
Estimated Study Completion Date: February 2007
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Shaheed Beheshti Medical University
Investigators
Principal Investigator: Babak Babsharif, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00370734     History of Changes
Other Study ID Numbers: 8375
Study First Received: August 31, 2006
Last Updated: February 26, 2007
Health Authority: Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:
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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013