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

Primary Purpose

Eye Diseases

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Botulinum toxin A injection

About this trial

This is an interventional treatment trial for Eye Diseases focused on measuring botulinum toxin, thyroid eye disease, lid retraction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy Exclusion Criteria: patients in non active phase

Sites / Locations

Babak Babsharif, MDRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00370734

First Posted

August 31, 2006

Last Updated

February 26, 2007

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00370734

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Unknown status

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eye Diseases

Keywords

botulinum toxin, thyroid eye disease, lid retraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin A injection

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy Exclusion Criteria: patients in non active phase

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Babak Babsharif, MD

Phone

+98 21 22585952

labbafi@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Babak Babsharif, MD

Organizational Affiliation

Ophthalmic Research Center of Shaheed Beheshti Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Babak Babsharif, MD

City

Tehran

ZIP/Postal Code

16666

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Babak Babsharif, MD

Phone

+98 21 22585952

labbafi@hotmail.com

12. IPD Sharing Statement

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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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