Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000305921
Ethics application status
Approved
Date submitted
20/03/2011
Date registered
22/03/2011
Date last updated
22/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measurements of central and peripheral refraction of the eye using a novel instrument, the EyeMapper.
Scientific title
A prospective, single-group, open-labelled study to measure central and peripheral refraction in healthy volunteers with a novel instrument, the EyeMapper.
Secondary ID [1] 252145 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central and peripheral refraction of the eye 257686 0
Condition category
Condition code
Eye 257860 257860 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Peripheral refraction instrument - mode of operation.
Participants will be recruited over a period of 5 months. Participants will be asked to attend the clinic for up to five visits. Each visit will take up to 1 hour. During these visits central and peripheral refraction measurements will be performed using up to three different instruments, the EyeMapper which is a novel peripheral refraction instrument, the Shin Nippon NVision K5001, a commercially available open view autorefractor and the COAS, a commercially available aberrometer.
Intervention code [1] 256747 0
Not applicable
Comparator / control treatment
Central and peripheral refraction measured with a commercially available autorefractor, the Shin-Nippon NVision K5001, and a commercially available COAS aberrometer will be used as control measures. Both instruments have slightly been modified to enable the measurement of the peripheral optics of the eye.
Control group
Active

Outcomes
Primary outcome [1] 258722 0
Central and peripheral refraction
Timepoint [1] 258722 0
Visit 1 (Baseline)
Secondary outcome [1] 264761 0
Instrument Preference Questionnaire
Timepoint [1] 264761 0
End of Visit 1

Eligibility
Key inclusion criteria
Participants enrolled in the trial must be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent and must be at least 18 years old.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants enrolled in the trial must not been currently enrolled in another clinical trial and must not have manifest strabismus or any anterior eye anomalies.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257242 0
Other
Name [1] 257242 0
Brien Holden Vision Institute
Country [1] 257242 0
Australia
Primary sponsor type
Other
Name
Brien Holden Vision Institute
Address
Level 5, North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 256485 0
None
Name [1] 256485 0
N/A
Address [1] 256485 0
N/A
Country [1] 256485 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259256 0
Vision Cooperative Research Centre and Institute for Eye Research Human Ethics Committee
Ethics committee address [1] 259256 0
Level 4, North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW Sydney NSW 2052
Ethics committee country [1] 259256 0
Australia
Date submitted for ethics approval [1] 259256 0
Approval date [1] 259256 0
18/08/2010
Ethics approval number [1] 259256 0
10/12/2011

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31359 0
Address 31359 0
Country 31359 0
Phone 31359 0
Fax 31359 0
Email 31359 0
Contact person for public queries
Name 14606 0
Cathleen Fedtke
Address 14606 0
Level 5, North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW Sydney NSW 2052
Country 14606 0
Australia
Phone 14606 0
+61 2 9385 7523
Fax 14606 0
Email 14606 0
c.fedtke@brienholdenvision.org
Contact person for scientific queries
Name 5534 0
Cathleen Fedtke
Address 5534 0
Level 5, North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW Sydney NSW 2052
Country 5534 0
Australia
Phone 5534 0
+61 2 9385 7523
Fax 5534 0
Email 5534 0
c.fedtke@brienholdenvision.org

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.