Thyroid-Associated Ophthalmopathy Subtypes and Orbital An... | NCT00430547

Studies
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

NCT00430547

Sponsor

Barwon Health

Status

Completed

Last Update Posted

Feb 2, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Graves' Ophthalmopathy

Interventions

Carbimazole, radio-active iodine (I131)

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Feb 1, 2007

First Submission Date that Met QC Criteria

Feb 1, 2007

First Posted Date

Feb 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2007

Last Update Posted Date

Feb 2, 2007Estimated

Name	Class
University of Melbourne	OTHER
National Health and Medical Research Council, Australia	OTHER

Description Module

Brief Summary

The purpose of this study is to determine whether radioactive iodine, as compared to anti-thyroid medications, is a risk factor for the development or progression of thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease. The other aim of this study is to determine the incidence of the various ophthalmopathy subtypes and the utility of orbital antibodies in the diagnosis, classification and monitoring of patients with thyroid-associated ophthalmopathy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Carbimazole, radio-active iodine (I131)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onset or progression of ophthalmopathy following radio-active iodine therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy

Exclusion Criteria:

Pre-existing eye disease: e.g. orbital surgery, orbital irradiation or significant loss of vision
Age < 18 years
Inability to consent to participation in the study
Pregnancy
History of radio-active iodine therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jack R Wall, BMBS, FRACP, PhD	University of Sydney	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barwon Health - The Geelong Hospital		Geelong	Victoria	3220	Australia

Condition Browse Module

MeSH Terms

ID	Term
D049970	Graves Ophthalmopathy

Ancestor Terms

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D006111	Graves Disease
D005094	Exophthalmos

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002231	Carbimazole
C000614965	Iodine-131

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided