Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001361796
Ethics application status
Approved
Date submitted
13/10/2022
Date registered
24/10/2022
Date last updated
24/10/2022
Date data sharing statement initially provided
24/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in ocular surface sensitivity with computer use
Scientific title
Changes in corneal and conjunctival sensitivity with computer use in symptomatic and asymptomatic computer workers.
Secondary ID [1] 308178 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Digital Eye Strain 327903 0
Dry eye disease 328027 0
Condition category
Condition code
Eye 324989 324989 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ocular surface (cornea and conjunctiva) sensitivity to mechanical and thermal stimuli will be measured before and after 1 hour of computer work, using for the purpose a recently developed aesthesiometer (the Liquid Jet Aesthesiometer (LJA) - only available for use in a a clinical trial setting), in a group of normal asymptomatic computer users and a group of computer users with symptoms of dry eye and digital eye strain. Participants will work on the computer in a free-choice task, until the examiner tells them to stop. The LJA propels microvolume droplets of saline solution onto the eye's surface. The participant will be seated in front of the LJA with adjustable headrest and chinrest in place and will be given a push button and asked to press it when any sensation is felt on the eye. The LJA will be used 4 times in single visit, before and after computer use. Each measurement is anticipated to last approximately 5 minutes and the duration of the visit in total will be approximately 2 hours, including 1 hour of computer use. All observations will be conducted in the School of Optometry and Vision Sciences at the University of New South Wales (UNSW) by experienced optometrists.
Intervention code [1] 324626 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will be made up of frequent computer users with no symptoms of dry eye or digital eye strain. Both groups of participants will undergo the same exposures and test procedures.
Control group
Active

Outcomes
Primary outcome [1] 332798 0
Changes in mechanical sensitivity of the cornea using the Liquid Jet Aesthesiometer
Timepoint [1] 332798 0
After working on a desktop computer for 60 minutes
Primary outcome [2] 332799 0
Changes in thermal sensitivity of the cornea using the Liquid Jet Aesthesiometer
Timepoint [2] 332799 0
After working on a desktop computer for 60 minutes
Primary outcome [3] 332899 0
Changes in mechanical sensitivity of the conjunctiva using the Liquid Jet Aesthesiometer
Timepoint [3] 332899 0
After working on a desktop computer for 60 minutes
Secondary outcome [1] 414725 0
Primary outcome: Changes in thermal sensitivity of the conjunctiva using the Liquid Jet Aesthesiometer.
Timepoint [1] 414725 0
After working on a desktop computer for 60 minutes
Secondary outcome [2] 415051 0
Changes in ocular symptoms assessed using the Computer Vision Syndrome Questionnaire (CVS-Q).
Timepoint [2] 415051 0
After working on a desktop computer for 60 minutes
Secondary outcome [3] 415052 0
Changes in ocular symptoms assessed using the Instant Ocular Symptoms Survey (IOSS).
Timepoint [3] 415052 0
After working on a desktop computer for 60 minutes
Secondary outcome [4] 415053 0
Changes in ocular symptoms assessed using the Ocular Comfort Index (OCI) questionnaire.
Timepoint [4] 415053 0
After working on a desktop computer for 60 minutes

Eligibility
Key inclusion criteria
• Aged between 18 to 40 years
• Frequent computer use (minimum of 4 hours of computer use per day)
• Able to read and comprehend English
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Have any eye or general health conditions which may affect the eyes.
• Current use of use eye and/or general medication which is known to affect eye health or eye comfort
• Have any history of eye surgery
• Use of soft contact lenses in the past 7 days or history of orthokeratology or rigid gas permeable contact lens wear.
• Are pregnant or breastfeeding
• Have a history of binocular disorders including amblyopia, strabismus or anisometropia.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minimum sample size was calculated a priori using G*Power tool – a statistical power analysis program. Considering the results of previous research of similar nature and with a = 0.05 and power (1 – ß) = 0.80 the required sample is that of 50 participants (25 participants per group). A minimum of 56 subjects will be recruited, accounting for potential study dropouts (10%) (28 participants per group) – a review of 71 randomized controlled trials in four top medical journals showed a median percentage of dropout rates of 10%.

Depending on the distribution of data, either a parametric paired-sample t-test or the non-parametric alternative Wilcoxon paired signed-rank test will be used to evaluate potential differences with task performance. Additionally, either a parametric independent t-test or the non-parametric alternative test of Mann-Whitney U will be used for group comparisons. The normality of data will be assessed using the Shapiro-Wilk test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/10/2022
Actual
Date of last participant enrolment
Anticipated
14/12/2022
Actual
Date of last data collection
Anticipated
14/12/2022
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23370 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 38752 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 312435 0
University
Name [1] 312435 0
University of New South Wales - UNSW
Country [1] 312435 0
Australia
Primary sponsor type
University
Name
University of New South Wales - UNSW
Address
UNSW Sydney
High St
Kensington NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 314012 0
None
Name [1] 314012 0
Address [1] 314012 0
Country [1] 314012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311783 0
HREC UNSW
Ethics committee address [1] 311783 0
Ethics committee country [1] 311783 0
Australia
Date submitted for ethics approval [1] 311783 0
27/09/2022
Approval date [1] 311783 0
11/10/2022
Ethics approval number [1] 311783 0
HC220450

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

Contacts
Principal investigator
Name 122346 0
Prof Fiona Stapleton
Address 122346 0
School of Optometry and Vision Science
Level 3, North Wing, Rupert Myers Building
Gate 14 Barker Street
UNSW Sydney NSW 2052
Country 122346 0
Australia
Phone 122346 0
+61 2 93854375
Fax 122346 0
Email 122346 0
[email protected]
Contact person for public queries
Name 122347 0
Fiona Stapleton
Address 122347 0
School of Optometry and Vision Science
Level 3, North Wing, Rupert Myers Building
Gate 14 Barker Street
UNSW Sydney NSW 2052
Country 122347 0
Australia
Phone 122347 0
+61 2 93854375
Fax 122347 0
Email 122347 0
[email protected]
Contact person for scientific queries
Name 122348 0
Fiona Stapleton
Address 122348 0
School of Optometry and Vision Science
Level 3, North Wing, Rupert Myers Building
Gate 14 Barker Street
UNSW Sydney NSW 2052
Country 122348 0
Australia
Phone 122348 0
+61 2 93854375
Fax 122348 0
Email 122348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17356Informed consent form    384822-(Uploaded-13-10-2022-12-19-59)-Study-related document.pdf
17357Ethical approval    384822-(Uploaded-13-10-2022-12-44-20)-Study-related document.pdf



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.