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
ACTRN12612001214820
Ethics application status
Approved
Date submitted
9/11/2012
Date registered
16/11/2012
Date last updated
2/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
To cross-validate the second generation EyeMapper (EyeMapper Gen 2) against the previously validated prototype instrument, EyeMapper Gen 1.
Scientific title
A prospective, open-labelled, cross-over, multiple group, randomised clinical trial measuring central and peripheral refractive errors and higher order aberrations using the EyeMapper Gen 1 and EyeMapper Gen 2 instruments in a minimum of 20 myopic and 20 non-myopic participants.
Secondary ID [1] 281517 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractive error of the eye. 287786 0
Condition category
Condition code
Eye 288138 288138 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to attend one visit. For the EyeMapper Gen 2 instrument, the participant’s head will be positioned on a chin rest and look at an internal fixation target. No contact will be made with the eye at any time. Following alignment, measurement is taken. Five consecutive measurements will be performed per instrument. Overall duration of measurements will be 10 minutes. The participants cross over measurements, not treatments so although this is a crossover trial there is no need for a wash out as the measurement is non invasive. The measurements will occur one after the other.
Intervention code [1] 286036 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will be required to attend one visit. For the EyeMapper Gen 1 instrument, the participant’s head will be positioned on a chin rest and look at an internal fixation target. No contact will be made with the eye at any time. Following alignment, measurement is taken. Five consecutive measurements will be performed per instrument. Overall duration of measurements will be 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 288336 0
To compare the central and peripheral refractive error and higher order aberrations between two peripheral aberrometers: the EyeMapper Gen 1 and the EyeMapper Gen 2.
Timepoint [1] 288336 0
Refractive error and high order aberration measures will be carried out with two non-invasive novel instruments (EyeMapper Gen 1 and EyeMapper Gen 2) before and after the dilation.
Secondary outcome [1] 299906 0
N/A
Timepoint [1] 299906 0
N/A

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be at least 18 years old, male or female.
Willing to comply with the clinical trial visit schedule as directed by the Investigator.
Have ocular health findings considered to be “normal”.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Rigid gas Permeable or orthokeratology lens wear in the past month.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another clinical trial.
Pregnancy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be screened for general clinical trial suitability by way of a routine eye examination which includes refraction, visual acuity and general eye health. Informed consent will be obtained prior to any clinical trial procedures. Both experienced contact lens wearers and neophytes (participants with no prior lens wear experience) will be enrolled into the study; of which, 20 participants will be recruited with spherical equivalent refractive errors greater than -0.75D (non-myopes), and another 20 participants will be recruited with spherical equivalent refractive errors less than or equal to -0.75D (myopes).

Enrolment will take place over approximately two months. A participant is enrolled when they have signed the Participant Information / Informed Consent Form. A participant is considered “successfully enrolled” when the Investigator agrees that they conform to the inclusion / exclusion criteria. Central rendomisation will be performed by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised for the order of examination with the two new instruments. The randomisation plan will be generated from http://www.randomisation.com and be done by central randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/2012
Actual
22/11/2012
Date of last participant enrolment
Anticipated
Actual
13/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286298 0
Charities/Societies/Foundations
Name [1] 286298 0
Brien Holden Vision Institute
Country [1] 286298 0
Australia
Primary sponsor type
Charities/Societies/Foundations
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] 285091 0
None
Name [1] 285091 0
N/A
Address [1] 285091 0
N/A
Country [1] 285091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288373 0
Bellberry Limited
Ethics committee address [1] 288373 0
229 Greenhill Road
Dulwich
south Australia 5065
Ethics committee country [1] 288373 0
Date submitted for ethics approval [1] 288373 0
27/09/2012
Approval date [1] 288373 0
05/11/2012
Ethics approval number [1] 288373 0
2012-08-993

Summary
Brief summary
To cross-validate the second generation EyeMapper (EyeMapper Gen 2) against the previously validated prototype instrument, EyeMapper Gen 1.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34935 0
Dr Ravi Bakaraju
Address 34935 0
Level 5, North Wing, Rupert Myers Building Gate 14, Barker Street UNSW Sydney NSW 2052
Country 34935 0
Australia
Phone 34935 0
+61 2 9385 7516
Fax 34935 0
Email 34935 0
[email protected]
Contact person for public queries
Name 18182 0
Dr Ravi Bakaraju
Address 18182 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 18182 0
Australia
Phone 18182 0
+61 2 9385 7516
Fax 18182 0
Email 18182 0
[email protected]
Contact person for scientific queries
Name 9110 0
Dr Ravi Bakaraju
Address 9110 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 9110 0
Australia
Phone 9110 0
+61 2 9385 7516
Fax 9110 0
Email 9110 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.