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

This study is currently recruiting participants.

Verified by Shaheed Beheshti Medical University, February 2007

First Received: August 31, 2006 Last Updated: February 26, 2007 History of Changes

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370734

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Eye Diseases

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin Thyroid

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

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

Keywords provided by Shaheed Beheshti Medical University:

botulinum toxin
thyroid eye disease
lid retraction

Additional relevant MeSH terms:

Goiter
Autoimmune Diseases
Immune System Diseases
Anti-Dyskinesia Agents
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Endocrine System Diseases
Pharmacologic Actions

Exophthalmos
Botulinum Toxins
Therapeutic Uses
Eye Diseases, Hereditary
Orbital Diseases
Central Nervous System Agents
Thyroid Diseases
Hyperthyroidism

ClinicalTrials.gov processed this record on November 27, 2009