Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001164785
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
24/08/2022
Date last updated
16/11/2023
Date data sharing statement initially provided
24/08/2022
Date results information initially provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of scleral lens perforations on tear flow in adults with healthy eyes
Scientific title
The effect of scleral contact lens fenestrations on tear exchange in adults with healthy corneas
Secondary ID [1] 307824 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tear exchange 327426 0
corneal oedema 327427 0
Condition category
Condition code
Eye 324551 324551 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a highly oxygen permeable scleral contact lens with mid-peripheral fenestrations. All lenses will be fitted to each individual eye and assessed by a contact lens practitioner with over 10 years experience. The fenestrated scleral lenses will be worn in both eyes for one 4 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] 324290 0
Treatment: Devices
Comparator / control treatment
The control is a highly oxygen permeable scleral contact lens with no fenestrations.
Control group
Active

Outcomes
Primary outcome [1] 332377 0
Change in central corneal thickness using optical coherence tomography
Timepoint [1] 332377 0
180 minutes after lens application
Primary outcome [2] 332378 0
Change in post lens fluid reservoir intensity using Scheimpflug imaging
Timepoint [2] 332378 0
5, 10, 15, 20, 30, 60, 90, 180 minutes after lens application
Primary outcome [3] 332379 0
Change in post lens fluid reservoir optical density using Scheimpflug imaging
Timepoint [3] 332379 0
30. 60. 90. 180 minutes after lens application
Secondary outcome [1] 413245 0
Subjective comfort using visual analogue scale
Timepoint [1] 413245 0
10 minutes, 190 minutes after lens application

Eligibility
Key inclusion criteria
Healthy adults aged over 18 years in good general health with normal visual acuity in each eye.
No contraindications to contact lens wear
No history or evidence of any ocular disease, injury, or surgery
Willing to refrain from soft contact lens wear for at least 24 hours prior to each study visit
Able to be fitted with scleral contact lenses required for the study
Minimum age
18 Years
Maximum age
No limit
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
Systemic disease (e.g. diabetes) or use of systemic medications (e.g. medications that affect the tear film)
Regular rigid contact lens wear
Unable to achieve a satisfactory lens fit with the study scleral contact lenses
Known allergy to sodium fluorescein or contact lens solutions

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2022
Actual
7/03/2023
Date of last participant enrolment
Anticipated
Actual
31/08/2023
Date of last data collection
Anticipated
Actual
19/10/2023
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312014 0
Commercial sector/Industry
Name [1] 312014 0
CooperVision International Limited
Country [1] 312014 0
United Kingdom
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George Street, Brisbane, QLD. 4001
Country
Australia
Secondary sponsor category [1] 313619 0
None
Name [1] 313619 0
Address [1] 313619 0
Country [1] 313619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311434 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 311434 0
Office of Research Ethics and Integrity, Level 4, 88 Musk Avenue, Kelvin Grove QLD 4059
Ethics committee country [1] 311434 0
Australia
Date submitted for ethics approval [1] 311434 0
15/08/2022
Approval date [1] 311434 0
21/10/2022
Ethics approval number [1] 311434 0
5469

Summary
Brief summary
The purpose of this study is to assess the effect of adding perforations to scleral contact lenses upon; 1) corneal tissue swelling, 2) tear flow behind the contact lens, and 3) build up of debris behind the contact lens in young healthy adults during short-term lens wear (3.5 hours). The null hypothesis is that the incorporation of scleral lens perforations will have no significant effect upon the primary outcome measures (1,2,3 listed above).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121082 0
A/Prof Stephen Vincent
Address 121082 0
School of Optometry and Vision Science, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD, 4059
Country 121082 0
Australia
Phone 121082 0
+61 7 31380415
Fax 121082 0
Email 121082 0
sj.vincent@qut.edu.au
Contact person for public queries
Name 121083 0
A/Prof Stephen Vincent
Address 121083 0
School of Optometry and Vision Science, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD, 4059
Country 121083 0
Australia
Phone 121083 0
+61 7 31380415
Fax 121083 0
Email 121083 0
sj.vincent@qut.edu.au
Contact person for scientific queries
Name 121084 0
A/Prof Stephen Vincent
Address 121084 0
School of Optometry and Vision Science, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD, 4059
Country 121084 0
Australia
Phone 121084 0
+61 7 31380415
Fax 121084 0
Email 121084 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.