Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001536257
Ethics application status
Approved
Date submitted
27/08/2018
Date registered
13/09/2018
Date last updated
13/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Repeatability of central and peripheral eye length and choroidal thickness measurements in healthy subjects.
Scientific title
Repeatability of central and peripheral eye length and choroidal thickness measurements in healthy subjects.
Secondary ID [1] 294503 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eye length
 307276 0
Choroidal thickness 309597 0
Condition category
Condition code
Eye 306394 306394 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross sectional and observational pilot study. The study sample will include participants with or without any refractive errors. The central and peripheral eye length and the thickness of the choroid will be analysed using the Lenstar LS 900 and the Triton Swept source OCT, respectively. The agreement between the readings obtained by both the instruments in two separate visits will be studied. The amount of time between visits will be between 1 to 40 days. The time between the visits will be determined based on the scheduling availability of the participant and the scheduling availability of equipment.
Intervention code [1] 301068 0
Not applicable
Comparator / control treatment
There is no control treatment in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305724 0
eye length as assessed by the Lenstar LS 900.
Timepoint [1] 305724 0
The repeatability of the measurements of the eye length will be assessed following two visits (between 1 and 40 days apart)
Primary outcome [2] 307394 0
choroid thickness as assessed by the Triton DRI Swept-source OCT.
Timepoint [2] 307394 0
The repeatability of the measurements of the choroidal thickness will be assessed following two visits (between 1 and 40 days apart).
Secondary outcome [1] 351094 0
-
Timepoint [1] 351094 0
-

Eligibility
Key inclusion criteria
• aged 18 years and over;
• Able to provide informed consent;
• either has a refractive error of the eye (a condition that causes blur for either distance or near) or no refractive error;
• have normal ocular health ;
• have good vision with or without corrective devices such as spectacles; and willing to comply with clinical trial visit schedule as directed by the investigator
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Less than 18 years of age;
• have history of a systemic health problem such as diabetes, hypertension, cardiac problem etc or an eye health problem;
• had any eye surgery or used orthokeratology lenses

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The eye length and choroidal thickness measurements will be compared between two different days using repeated measures ANOVA.
Prior studies have shown that the within-subject standard deviation for choroidal thickness was about 13 micros. Assuming that the clinical significance is CT is 10 micros, a minimum sample of 15 Participants up to 40 participants will be required to determine if there is a significant difference of 10 ± 13 micros between repeat sessions with 80% power at the 5% level of significance. No adjustment is made for dropouts due to the short nature of the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/09/2017
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
3/12/2018
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299129 0
Other Collaborative groups
Name [1] 299129 0
Brien Holden Vision Institute
Country [1] 299129 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brien Holden Vision Institute
Address
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 298387 0
None
Name [1] 298387 0
Address [1] 298387 0
Country [1] 298387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300061 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 300061 0
RECS - Human Research Ethics Team
Research Ethics and Compliance Support (RECS), Research Division
UNSW Sydney NSW 2052 Australia
Ethics committee country [1] 300061 0
Australia
Date submitted for ethics approval [1] 300061 0
31/05/2017
Approval date [1] 300061 0
18/07/2017
Ethics approval number [1] 300061 0
HC17441

Summary
Brief summary
This study aims to determine the repeatability of two investigational instruments ( the Lenstar LS 900 and the Triton Swept-source OCT). The instruments are used in optometric research to assess the length of the eye and the thickness of the vascular layer of the eye ( the choroid). To achieve this we wish to take measurements using the instruments over two separate days. The study sample will include a minimum of 15 participants to up to 40 participants with or without refractive errors, we wish to assess the repeatability of the instruments by taking two sets of measurements on two different days.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82434 0
Dr Klaus Ehrmann
Address 82434 0
Brien Holden Vision Institute,
Level 5, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 82434 0
Australia
Phone 82434 0
+612 93857495
Fax 82434 0
Email 82434 0
[email protected]
Contact person for public queries
Name 82435 0
Dr Klaus Ehrmann
Address 82435 0
Brien Holden Vision Institute,
Level 5, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 82435 0
Australia
Phone 82435 0
+612 93857495
Fax 82435 0
Email 82435 0
[email protected]
Contact person for scientific queries
Name 82436 0
Dr Klaus Ehrmann
Address 82436 0
Brien Holden Vision Institute,
Level 5, North Wing, RMB, Gate 14, Barker Street UNSW SYDNEY NSW 2052 AUSTRALIA
Country 82436 0
Australia
Phone 82436 0
+612 93857495
Fax 82436 0
Email 82436 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

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