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Trial registered on ANZCTR


Registration number
ACTRN12611001103954
Ethics application status
Approved
Date submitted
19/10/2011
Date registered
24/10/2011
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparision of two new ocular scanning refraction instruments
Scientific title
A prospective, open-labelled, multiple group, randomised, instrument validation clinical trial measuring central and peripheral refractive errors and higher order aberrations in healthy volunteers using two instruments: EyeMapper and HS Scanner with undilated and dilated pupils.
Secondary ID [1] 273236 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 and high order aberrations 278996 0
Condition category
Condition code
Eye 279178 279178 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 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
Intervention code [1] 269569 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will be required to attend one visit. For the HS Scanner, the participant’s head will be positioned on a chin rest and look at an external 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] 279818 0
To compare the central and peripheral refractive error and higher order aberrations between two new peripheral aberrometers: the EyeMapper and the HS Scanner
Timepoint [1] 279818 0
Refractive error and high order aberration measures will be carried out with two non-invasive novel instruments (EyeMapper and Hartmann-Shack Scanner) before and after the dilation.
Secondary outcome [1] 294504 0
N/A
Timepoint [1] 294504 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”.
Spherical equivalent refractive error between +1.50D and -4.00D (with astigmatism less than 4.00D)
Minimum age
18 Years
Maximum age
No limit
Gender
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.
Participation in a clinical trial within the previous 24 hours for dispensing studies and in-house studies.

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)
The planned number of participants is minimum of 48; of which, 24 participants will be recruited with spherical equivalent refractive errors ranging between +1.50D and -0.25D, and another 24 participants will be recruited with spherical equivalent refractive errors ranging between -0.50D and -4.00D.

Allocation concealment will be by means of central randomisation by computer.

Enrolment will take place over approximately 1 month.
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.
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Validation study
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12715 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 270064 0
Charities/Societies/Foundations
Name [1] 270064 0
Brien Holden Vision Institute
Address [1] 270064 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country [1] 270064 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
Australia
Country
Australia
Secondary sponsor category [1] 269027 0
None
Name [1] 269027 0
N/A
Address [1] 269027 0
N/A
Country [1] 269027 0
Other collaborator category [1] 252305 0
University
Name [1] 252305 0
Laboratorio de Optica, University of Murcia, Spain
Address [1] 252305 0
Centro de Investigacion en Optica y Nanofisica
Campus Espinardo
E-30071, Murcia
Country [1] 252305 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272020 0
Bellbery Limited
Ethics committee address [1] 272020 0
229 Greenhill Road
Dulwich
south Australia 5065
Ethics committee country [1] 272020 0
Australia
Date submitted for ethics approval [1] 272020 0
12/10/2011
Approval date [1] 272020 0
20/10/2011
Ethics approval number [1] 272020 0

Summary
Brief summary
To cross-validate two new peripheral aberrometers: the EyeMapper and the Hartmann-Shack (HS) Scanner with dilated and undilated pupils.
Trial website
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 33283 0
Dr Ravi Bakaraju
Address 33283 0
Level 5, North Wing, Rupert Myers Building Gate 14, Barker Street UNSW Sydney NSW 2052 Australia
Country 33283 0
Australia
Phone 33283 0
+61 2 9385 7516
Fax 33283 0
Email 33283 0
r.bakaraju@brienholdenvision.org
Contact person for public queries
Name 16530 0
Dr Dr Ravi Bakaraju
Address 16530 0
Level 5, North Wing, Rupert Myers Building Gate 14, Barker Street UNSW Sydney NSW 2052 Australia
Country 16530 0
Australia
Phone 16530 0
+61 2 9385 7516
Fax 16530 0
Email 16530 0
r.bakaraju@brienholdenvision.org
Contact person for scientific queries
Name 7458 0
Dr Ravi Bakaraju
Address 7458 0
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country 7458 0
Australia
Phone 7458 0
+61 2 9385 7516
Fax 7458 0
Email 7458 0
r.bakaraju@brienholdenvision.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary