Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001575729
Ethics application status
Approved
Date submitted
16/12/2022
Date registered
20/12/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
20/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of astigmatic correction with Precision 1 Toric contact lenses on functional vision with digital devices
Scientific title
The impact of astigmatic correction with Precision 1 Toric contact lenses on functional vision with digital devices in healthy participants with low to moderate astigmatism
Secondary ID [1] 308626 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Astigmatism 328529 0
Condition category
Condition code
Eye 325545 325545 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a soft disposable contact lens that provides an optical correction for astigmatism. The lenses will be fit to individual participants' eyes by an experienced (>10 years) research optometrist, to provide optimal correction for their low to moderate astigmatic refractive errors. The astigmatism correcting lens will be worn in both eyes for a single 60-minute session in a research laboratory/clinical facility. The order of lens wear (intervention/control) will be randomized. All participants will wear the intervention and control lenses in separate sessions on different days at least 24 hours apart (i.e. crossover study design).
Intervention code [1] 325080 0
Treatment: Devices
Comparator / control treatment
The control is a disposable contact lens (of the same lens material as the intervention). that corrects the spherical equivalent component of the refractive error
Control group
Active

Outcomes
Primary outcome [1] 333390 0
Change in near visual performance (high contrast and low contrast logMAR near visual acuity at 40 cm) associated with astigmatism correcting contact lenses.
Timepoint [1] 333390 0
Following lens insertion and settling
Primary outcome [2] 333391 0
Safety of astigmatism correcting contact lenses (incidence of adverse events graded using clinical grading scales)
Timepoint [2] 333391 0
Following lens insertion and settling and assessment of visual performance
Secondary outcome [1] 416873 0
Change in functional visual performance involving more complex visual and cognitive skills (reading speed for high contrast and low contrast smart phone reading task) associated with astigmatism correcting contact lenses
Timepoint [1] 416873 0
Following lens insertion and settling
Secondary outcome [2] 417007 0
Change in functional visual performance involving more complex visual and cognitive skills (time to complete Trail Making Test) associated with astigmatism correcting contact lenses
Timepoint [2] 417007 0
Following lens insertion and settling
Secondary outcome [3] 417008 0
Change in functional visual performance involving more complex visual and cognitive skills (performance on Digit Symbol Substitution Test) associated with astigmatism correcting contact lenses
Timepoint [3] 417008 0
Following lens insertion and settling
Secondary outcome [4] 417009 0
Change in objective markers of visual fatigue (change in palpebral aperture width, blink rate, pupil size) associated with near vision tasks on digital devices associated with astigmatism correcting contact lenses.
Timepoint [4] 417009 0
Following lens insertion and settling and assessment of visual performance

Eligibility
Key inclusion criteria
Healthy adults with normal corrected visual acuity in each eye
Refractive astigmatism between -0.50 and -1.50 D
Spherical refractive error of between 0.00 and -6.00 D
Normal binocular vision and accommodative function
Prior history of successful soft contact lens wear
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of eye disease, surgery, or injury
Contraindications to contact lens wear
Signs or symptoms of dry eye or ocular surface disease
Regular rigid contact lens wear
Unable to achieve a satisfactory lens fit with the study contact lenses

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)
In this randomized cross-over trial, all participants will wear both the treatment and control lenses. The allocation of lens type worn at each visit will be concealed from the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be tested for normality and then appropriate parametric or non-parametric tests will be applied. Repeated measures ANOVA (or the non-parametric equivalent Friedman test) will be used to determine significant differences between visual performance with astigmatism correction and best sphere correction, for each of the primary and secondary endpoints.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2023
Actual
30/01/2023
Date of last participant enrolment
Anticipated
Actual
24/05/2023
Date of last data collection
Anticipated
Actual
6/06/2023
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312865 0
Commercial sector/Industry
Name [1] 312865 0
Alcon Laboratories (Australia) Pty Ltd
Country [1] 312865 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George Street
Brisbane, QLD 4001
Country
Australia
Secondary sponsor category [1] 314528 0
None
Name [1] 314528 0
Address [1] 314528 0
Country [1] 314528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312142 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 312142 0
Ethics committee country [1] 312142 0
Australia
Date submitted for ethics approval [1] 312142 0
21/11/2022
Approval date [1] 312142 0
14/12/2022
Ethics approval number [1] 312142 0
6494

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

Contacts
Principal investigator
Name 123630 0
Prof Scott Read
Address 123630 0
School of Optometry and Vision Science
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD, 4059
Country 123630 0
Australia
Phone 123630 0
+61731385714
Fax 123630 0
Email 123630 0
[email protected]
Contact person for public queries
Name 123631 0
Scott Read
Address 123631 0
School of Optometry and Vision Science
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD, 4059
Country 123631 0
Australia
Phone 123631 0
+61731385714
Fax 123631 0
Email 123631 0
[email protected]
Contact person for scientific queries
Name 123632 0
Scott Read
Address 123632 0
School of Optometry and Vision Science
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD, 4059
Country 123632 0
Australia
Phone 123632 0
+61731385714
Fax 123632 0
Email 123632 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
There will be no IPD sharing for this project. Group data analysis will be conducted and this data will be used for all publications


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.