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Trial registered on ANZCTR
Registration number
ACTRN12620000761965p
Ethics application status
Submitted, not yet approved
Date submitted
18/05/2020
Date registered
27/07/2020
Date last updated
27/07/2020
Date data sharing statement initially provided
27/07/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessing the role of conjunctival and lid margin sensitivity has in ocular discomfort
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Scientific title
To investigate the sensitivity of the conjunctiva and lid margin to cold stimuli and determine the repeatability of sensitivity measurement using the Liquid Jet Aesthesiometer (LJA)
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Secondary ID [1]
301322
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Nil known
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Universal Trial Number (UTN)
U1111-1252-2135
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ocular discomfort
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Condition category
Condition code
Eye
315618
315618
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Brief name: Air Jet Stimulation of the Conjunctiva and Lid Margin
Brief Description: Different parts of the eyes have different sensitivities and contribute to ocular discomfort in different ways. By using a machine which causes air jet stimulation of certain sites of the eye, the sensitivity of the structure can be determined and linked to the level of ocular discomfort they experience.
The machine is attached to a slit lamp bio-microscope where a subject places their chin and forehead onto the attached rest. The participant is instructed to look a target in the room and the machine is manoeuvred and aimed at the appropriate site of the eye.
Duration of observation: Each test to measure sensitivity will span approximately 10 minutes. With multiple repeats at different ocular sites, the time needed to complete the observation will be approximately 2.5 hours. There will be 1 repeat on the cornea, 3 repeats on the bulbar conjunctiva and 1 repeat on the lid margins. The session will be conducted and administered by final year optometry students under the supervision of A/Prof Blanka Golebiowski, Adj Professor Klaus Ehrmann and Professor Fiona Stapleton.
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Intervention code [1]
317718
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To investigate the sensitivity of the conjunctiva to cold stimuli using the LJA to detect via a staircase method whether a variety of stimuli at different intensities can be felt. The participant can indicate if a particular intensity is felt by clicking a provided button.
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Assessment method [1]
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Timepoint [1]
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At the completion of the observation session
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Primary outcome [2]
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Determine the repeatability of sensitivity measurement using the LJA.
At the end of each scheduled visit, the Liquid Jet Aesthesiometer will provide us with quantitative threshold data that will be statistically analysed once all data has been collected. The paired sample t-test is used to determine whether the mean difference between the two samples are zero, and therefore determine whether the measurements with the LJA when a cold stimulus is repeatable.
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Assessment method [2]
323968
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Timepoint [2]
323968
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At the completion of the observation session with all participants
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Primary outcome [3]
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To investigate the sensitivity of the lid margin to cold stimuli using the LJA to detect via a staircase method whether a variety of stimuli at different intensities can be felt. The participant can indicate if a particular intensity is felt by clicking a provided button.
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Assessment method [3]
324237
0
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Timepoint [3]
324237
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At the completion of the observation session
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Secondary outcome [1]
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Ocular discomfort as measured by the Ocular Surface Disease Index, Ocular Comfort Index and the Instant Ocular Symptoms Survey. These are all in the form of questionnaires.
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Assessment method [1]
383053
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Timepoint [1]
383053
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At the completion of the observation session
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Eligibility
Key inclusion criteria
18 to 40 years old
Able to read and comprehend English
Either a full-time soft contact lens wearer or do not wear contact lenses
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Have any eye or general health conditions which may affect your eyes, for example severe dry eye, active eye allergy, Graves’ disease, diabetes, Sjögren syndrome or multiple sclerosis
Have any eye infections or inflammation
Currently use eye and/or general medication which is known to affect eye health or eye comfort, such as chloramphenicol, prednisolone acetate, Accutane, antidepressant medications, topical glaucoma drops or anti-allergy drops
Have any history of eye surgery like corneal refractive surgery or cataract surgery
Wear soft contact lenses overnight or on an intermittent or part-time basis only
Are a current or previous wearer of hard contact lenses, including Ortho-K lenses
Are pregnant or breastfeeding
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
The instrumentation is designed to reach a threshold value using a programmed double staircase method and data will be collected using the software linked to the LJA. The data will have to be processed manually by inputting the values collected by the software into an Excel spreadsheet for subsequent analysis. Subsequent analysis will involve grouping independent and/or dependent variables appropriately and entering said data into data analysis and graphing software such as SPSS. Through SPSS, the repeatability of the machine can be determined, it can compare values from the conjunctiva and lid margin and examine if sex or contact lens wear influences ocular discomfort. A two-way analysis of variance (ANOVA) will be used to detect differences in threshold between different ocular sites and the Bonferroni Post Hoc Test will be used to determine between group (CL vs non-CL lens) groups.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/08/2020
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Actual
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Date of last participant enrolment
Anticipated
31/10/2020
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Actual
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Date of last data collection
Anticipated
31/10/2020
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
30305
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2052 - Unsw Sydney
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Funding & Sponsors
Funding source category [1]
305759
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University
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Name [1]
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UNSW Australia
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Address [1]
305759
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UNSW Sydney
High St
Kensington, NSW 2052
Australia
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Country [1]
305759
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Australia
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Primary sponsor type
University
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Name
UNSW Australia
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Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
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Country
Australia
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Secondary sponsor category [1]
306194
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None
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Name [1]
306194
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Address [1]
306194
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Country [1]
306194
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Other collaborator category [1]
281319
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Individual
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Name [1]
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Blanka Golebiowski
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Address [1]
281319
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Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
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Country [1]
281319
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Australia
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Other collaborator category [2]
281320
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Individual
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Name [2]
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Fiona Stapleton
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Address [2]
281320
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Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
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Country [2]
281320
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Australia
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Other collaborator category [3]
281321
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Individual
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Name [3]
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Anne Chung
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Address [3]
281321
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Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
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Country [3]
281321
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Australia
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Other collaborator category [4]
281322
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Individual
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Name [4]
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Klaus Ehrmann
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Address [4]
281322
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Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
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Country [4]
281322
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
306031
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UNSW Human Research Ethics Committee (HREC)
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Ethics committee address [1]
306031
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UNSW Sydney NSW 2052 Australia
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Ethics committee country [1]
306031
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Australia
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Date submitted for ethics approval [1]
306031
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08/04/2020
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Approval date [1]
306031
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Ethics approval number [1]
306031
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Summary
Brief summary
The research study aims to investigate the sensitivity of the eyelid margin and the conjunctiva (a thin layer on the white part of your eye) using an instrument called the Liquid Jet aesthesiometer, which uses small drops of saline to stimulate your eye. Participants will be invited to take part in this study to help us better understand what the role the conjunctiva and lid margin have in eye discomfort, and to analyse the repeatability of this new instrument.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
102486
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A/Prof Blanka Golebiowski
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Address
102486
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Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
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Country
102486
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Australia
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Phone
102486
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+612 9385 4502
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Fax
102486
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+61 2 9313 6243
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Email
102486
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[email protected]
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Contact person for public queries
Name
102487
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A/Prof Blanka Golebiowski
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Address
102487
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Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
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Country
102487
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Australia
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Phone
102487
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+612 9385 4502
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Fax
102487
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+61 2 9313 6243
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Email
102487
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[email protected]
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Contact person for scientific queries
Name
102488
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A/Prof Blanka Golebiowski
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Address
102488
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Level 3, North Wing, Rupert Myers Building, Gate 14 Barker St, UNSW SYDNEY 2052 NSW
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Country
102488
0
Australia
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Phone
102488
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+612 9385 4502
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Fax
102488
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+61 2 9313 6243
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Email
102488
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data will not be publicly available with consent from participants only allowing for data to be available to researchers in future studies.
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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.
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