Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000047594
Ethics application status
Approved
Date submitted
29/12/2023
Date registered
19/01/2024
Date last updated
19/01/2024
Date data sharing statement initially provided
19/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of scleral lens channels on tear flow in adults with healthy eyes
Scientific title
The effect of scleral contact lens channels on tear flow in adults with healthy eyes
Secondary ID [1] 310947 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
corneal oedema 332024 0
Condition category
Condition code
Eye 328754 328754 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a scleral contact lens with landing zone modifications (channels). All lenses will be fitted to each individual eye and assessed by contact lens practitioners with over 10 years of experience. Scleral lenses will be worn in one eye for one 6 hour session in a research laboratory/clinical facility. The order of lens wear (intervention/control) will be randomized. The intervention and control lenses will be worn on different days with at least one day without contact lens wear separating the two measurement sessions.
Intervention code [1] 327376 0
Treatment: Devices
Comparator / control treatment
The control is the same scleral contact lens design with no channels.
Control group
Active

Outcomes
Primary outcome [1] 336566 0
Corneal oedema
Timepoint [1] 336566 0
0, 180, 360 minutes after lens application
Primary outcome [2] 336567 0
Tear exchange
Timepoint [2] 336567 0
0, 180, 360 minutes after lens application
Primary outcome [3] 336568 0
Lens centration
Timepoint [3] 336568 0
0, 180, 360 minutes after lens application
Secondary outcome [1] 428825 0
Visual acuity
Timepoint [1] 428825 0
0 and 360 minutes after lens application
Secondary outcome [2] 428826 0
Tissue compression
Timepoint [2] 428826 0
0, 180, 360 minutes after lens application
Secondary outcome [3] 430814 0
Lens rotation (primary outcome)
Timepoint [3] 430814 0
0, 180, 360 minutes

Eligibility
Key inclusion criteria
- Age 18- under 40 years
- At least 0.00 logMAR visual acuity in each eye
- No significant ocular disease
- No significant eye movement anomalies
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any systemic disease, allergies, immunosuppressive diseases, autoimmune diseases, COVID-19
- Use of systemic medications known to have a side effect in the eyes or vision
- Current use of any ocular medication
- Ocular disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315207 0
Commercial sector/Industry
Name [1] 315207 0
Menicon Co. Ltd.
Country [1] 315207 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
Capricornia Contact Lenses
Address
U2 9 Cronulla Ct, SLACKS CREEK Queensland 4127
Country
Australia
Secondary sponsor category [1] 317240 0
None
Name [1] 317240 0
Address [1] 317240 0
Country [1] 317240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314132 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 314132 0
Office of Research Ethics and Integrity, Level 4, 88 Musk Avenue, Kelvin Grove QLD 4059
Ethics committee country [1] 314132 0
Australia
Date submitted for ethics approval [1] 314132 0
21/09/2023
Approval date [1] 314132 0
18/12/2023
Ethics approval number [1] 314132 0

Summary
Brief summary
The purpose of this study is to assess the effect of adding channels to scleral contact lenses upon corneal tissue swelling and tear flow behind the contact lens in young healthy adults during short-term lens wear (6 hours). The null hypothesis is that the incorporation of scleral lens channels will have no significant effect upon the primary outcome measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130526 0
Prof Stephen Vincent
Address 130526 0
Discipline of Optometry and Vision Science, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD, 4059
Country 130526 0
Australia
Phone 130526 0
+61 7 31380415
Fax 130526 0
Email 130526 0
sj.vincent@qut.edu.au
Contact person for public queries
Name 130527 0
Prof Stephen Vincent
Address 130527 0
Discipline of Optometry and Vision Science, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD, 4059
Country 130527 0
Australia
Phone 130527 0
+61 7 31380415
Fax 130527 0
Email 130527 0
sj.vincent@qut.edu.au
Contact person for scientific queries
Name 130528 0
Prof Stephen Vincent
Address 130528 0
Discipline of Optometry and Vision Science, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD, 4059
Country 130528 0
Australia
Phone 130528 0
+61 7 31380415
Fax 130528 0
Email 130528 0
sj.vincent@qut.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
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.