Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000582257
Ethics application status
Approved
Date submitted
9/07/2009
Date registered
14/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An analysis of torsion in superior oblique palsy
Scientific title
An analysis of torsion in superior oblique palsy
Secondary ID [1] 918 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superior oblique palsy 237204 0
Condition category
Condition code
Eye 237523 237523 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Image tilt (torsion) will be observed using
three commonly used clinical measures of torsion; the synoptophore, double Maddox rod and Torsionometer. These three tests all measure in degrees the amount of torsion as subjectively indicated by the participant.
Intervention code [1] 236905 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238334 0
The amount of torsion in degrees using the synoptophore, double Maddox rod and Torsionometer.
Timepoint [1] 238334 0
Measured only once as close as possible to the onset of the superior oblique palsy
Secondary outcome [1] 244741 0
Nil
Timepoint [1] 244741 0
Nil

Eligibility
Key inclusion criteria
Patients with acquired unilateral or bilateral superior oblique palsy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237303 0
Self funded/Unfunded
Name [1] 237303 0
Country [1] 237303 0
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora
Victoria 3086
Country
Australia
Secondary sponsor category [1] 236788 0
Hospital
Name [1] 236788 0
Royal Victorian Eye and Ear Hospital
Address [1] 236788 0
32 Gisborne Street
East Melbourne
Victoria 3002
Country [1] 236788 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239400 0
La Trobe University Faculty Human Ethics Committee (FHEC), Faculty of Health Sciences
Ethics committee address [1] 239400 0
Bundoora
Victoria 3086
Ethics committee country [1] 239400 0
Australia
Date submitted for ethics approval [1] 239400 0
Approval date [1] 239400 0
05/06/2009
Ethics approval number [1] 239400 0
FHEC 09/100

Summary
Brief summary
The purpose of this study is to investigate the difference in torsion in primary position (head straight, looking straight ahead) and compare it to measurements in 15 and 30 degrees in downgaze (head straight, eyes looking downwards). It is hypothesised that torsion will increase in downgaze, especially in cases of bilateral superior oblique palsy. Therefore, we hope to establish an amount of torsion that differentiates bilateral and unilateral superior oblique palsy. This will help clinicians plan treatment and hopes to avoid cases of "masked" superior oblique palsy (where after surgery for a unilateral superior oblique palsy, a superior oblique palsy is uncovered in the other eye).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29875 0
Address 29875 0
Country 29875 0
Phone 29875 0
Fax 29875 0
Email 29875 0
Contact person for public queries
Name 13122 0
Kara Muecke
Address 13122 0
C/- Zoran Georgievski
La Trobe University
Bundoora
VICTORIA, 3086
Country 13122 0
Australia
Phone 13122 0
+61 430 292 774
Fax 13122 0
Email 13122 0
[email protected]
Contact person for scientific queries
Name 4050 0
Kara Muecke
Address 4050 0
C/- Zoran Georgievski
La Trobe University
Bundoora
VICTORIA, 3086
Country 4050 0
Australia
Phone 4050 0
+61 430 292 774
Fax 4050 0
Email 4050 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.