Please note that the ANZCTR website will be unavailable from 12am until 6am (AEST) on Sunday 22nd September 2019. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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
ACTRN12619000057189
Ethics application status
Approved
Date submitted
20/11/2018
Date registered
16/01/2019
Date last updated
16/01/2019
Date data sharing statement initially provided
16/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Spectacle interventions for treating eye strain with computer use
Scientific title
Investigating spectacle interventions for computer vision syndrome by assessing the change in subjective visual fatigue score and critical flicker frequency pre and post computer task.
Secondary ID [1] 296385 0
None
Universal Trial Number (UTN)
U1111-1222-9240
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Computer vision syndrome 310135 0
Condition category
Condition code
Eye 308881 308881 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. The subjects will be randomised to one of four spectacle lenses of different brands. Intervention 1 – spectacle lens brand 1; intervention 2 – spectacle lens brand 2; intervention 3 – spectacle lens brand 3; intervention 4 – spectacle lens brand 4.

2. For the purposes of the study, “laboratory conditions” denotes the running of the experiment within a designated research laboratory space, in which critical aspects of the tasks (e.g. equipment, light levels, absence of other distractions) are well-controlled environment, and run according to a standardized procedure.

3. Participants will be advised to wear spectacle lenses for a total duration of 2-hours whilst performing the computer task, which involves transcribing numbers from a PDF document into a spreadsheet and identifying data entry errors from a document presented on a computer screen.
Intervention code [1] 312721 0
Treatment: Devices
Comparator / control treatment
“Intervention 4 – spectacle lens brand 4” will be the comparator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 307861 0
Patient symptoms – measured using a visual fatigue questionnaire survey score (developed by Sheedy et al., 2003 [Sheedy et al. Is all asthenopia the same? Optom Vis Sci. 2003 Nov;80(11):732-9]) designed to grade the severity of visual fatigue.
Timepoint [1] 307861 0
Change in visual fatigue score pre and post 2-hours of computer task
Primary outcome [2] 307862 0
Critical flicker frequency - measured using a custom-built light emitting diode-based stimulus
Timepoint [2] 307862 0
Change in critical flicker frequency measurement pre and post 2-hours of computer task.
Secondary outcome [1] 353166 0
Blink rate will be assessed by recording the eyes with a web-camera, so that the number of blinks can be counted off-line.
Timepoint [1] 353166 0
Change in total number of eye blinks per minute, at the beginning (5 minutes) and end (5 minutes) of the 2-hour computer task.
Secondary outcome [2] 353167 0
Eye movements – measured using a saccadometer (Ober Consulting, Poznan, Poland) instrument.
Timepoint [2] 353167 0
Change in eye movements, pre and post 2-hours of computer task.
Secondary outcome [3] 353168 0
Near point of convergence quantified using the push-up method.
Timepoint [3] 353168 0
Change in near point of convergence pre and post 2-hours of computer task.
Secondary outcome [4] 353337 0
Incidence of adverse events
1. The adverse events will be self-reported by the participants
2. The present study is designed to elicit a level of computer vision syndrome by making the participants perform computer task for 2-hours, following which the symptoms will be assessed using a 9-item questionnaire which captures degree of eye strain, blurred vision, ocular irritation, double vision, burning sensation, dry eyes, tearing of eyes, and headache. As such, these induced effects are not adverse affects. However, an adverse event which could result with prolonged computer use is muscular-skeletal discomfort.
Timepoint [4] 353337 0
At the end of the of the 2-hour computer task.
Secondary outcome [5] 365392 0
Near point of accommodation quantified using the push-up method.
Timepoint [5] 365392 0
Change in near point of accommodation pre and post 2-hours of computer task.

Eligibility
Key inclusion criteria
- Computer users with symptoms of computer vision syndrome (as determined by a standardised questionnaire, developed by Segui Mdel et al. 2015 [Segui Mdel et al. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol, 68(6), 662-673])
- Habitual use of computer without spectacles
- Unaided binocular near vision of greater than N8 at 30 – 40 cm
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Neurological disease (by self-report)
- Migraine (by self-report)
- Nystagmus
- Optometrist/Ophthalmologist/Orthoptist/OD students and dispensing opticians


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After individuals provide consent, they will be randomised to one of four spectacle interventions. Allocation will be concealed using sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using a computer-generated number list, using a block size of 20.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The statistical approach will involve inter-group comparisons using an ANOVA.

Recruitment
Recruitment status
Not yet recruiting
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)
VIC
Recruitment postcode(s) [1] 24418 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 300997 0
University
Name [1] 300997 0
The University of Melbourne
Address [1] 300997 0
Monash Rd, Parkville VIC 3052
Country [1] 300997 0
Australia
Primary sponsor type
Individual
Name
Assoc. Prof. Andrew Anderson
Address
Department of Optometry and Vision Sciences
Level 4 – Alice Hoy Building (Bldg 162), Monash Road
The University of Melbourne
Parkville, Victoria, Australia 3010
Country
Australia
Secondary sponsor category [1] 300586 0
None
Name [1] 300586 0
Address [1] 300586 0
Country [1] 300586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301751 0
'University of Melbourne - Psychology health and applied sciences human ethics sub-committee
Ethics committee address [1] 301751 0
Office for Research Ethics and Integrity, The University of Melbourne, 1/21 Bedford St, North Melbourne VIC 3051
Ethics committee country [1] 301751 0
Australia
Date submitted for ethics approval [1] 301751 0
14/08/2018
Approval date [1] 301751 0
05/10/2018
Ethics approval number [1] 301751 0
1852643

Summary
Brief summary
Computer vision syndrome is defined as a group of eye and vision related problems that result from prolonged computer, tablet, e-reader or cell phone use. Its prevalence ranges from 75% to 90% among computer users. The most common ocular symptoms associated with computer vision syndrome are visual fatigue, followed by blurred vision, and dry eyes; these symptoms occur immediately, or after several hours of computer use. Recently, spectacle lenses have been introduced into the clinical practice with an aim to alleviate symptoms of computer vision syndrome. However, there are currently no high quality clinical trials that have investigated the efficacy of these lenses for the treatment of computer vision syndrome. Hence, this project comprises of series of experiments to scientifically investigate whether these spectacle interventions affect signs and symptoms of computer vision syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87978 0
A/Prof Andrew Anderson
Address 87978 0
Department of Optometry and Vision Sciences
Level 4 – Alice Hoy Building (Bldg 162), Monash Road
The University of Melbourne
Parkville, Victoria, Australia 3010
Country 87978 0
Australia
Phone 87978 0
+61 390359916
Fax 87978 0
Email 87978 0
aaj@unimelb.edu.au
Contact person for public queries
Name 87979 0
A/Prof Andrew Anderson
Address 87979 0
Department of Optometry and Vision Sciences
Level 4 – Alice Hoy Building (Bldg 162), Monash Road
The University of Melbourne
Parkville, Victoria, Australia 3010
Country 87979 0
Australia
Phone 87979 0
+61 390359916
Fax 87979 0
Email 87979 0
aaj@unimelb.edu.au
Contact person for scientific queries
Name 87980 0
A/Prof Andrew Anderson
Address 87980 0
Department of Optometry and Vision Sciences
Level 4 – Alice Hoy Building (Bldg 162), Monash Road
The University of Melbourne
Parkville, Victoria, Australia 3010
Country 87980 0
Australia
Phone 87980 0
+61 390359916
Fax 87980 0
Email 87980 0
aaj@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per the ethics only researchers named on this application will have access to the data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results