Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623000823673
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
1/08/2023
Date last updated
31/08/2023
Date data sharing statement initially provided
1/08/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
A trial to assess the retinal function of the eye when using a novel contact lens for myopia management
Query!
Scientific title
Evaluation of retinal ganglion cell function and ocular changes with A.R.R.E.S.T® contact lens design in emmetropic and myopic adults aged 18-25.
Query!
Secondary ID [1]
309977
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Myopia
330467
0
Query!
Condition category
Condition code
Eye
327318
327318
0
0
Query!
Normal eye development and function
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
This is a prospective, randomised, contralateral clinical trial. All participants will wear one test and one control contact lens simultaneously. The eye in which each the test and control is worn will be randomly determined. All contact lenses are made from a commercially available HEMA material (55% water) and are single use. The test will be a single vision contact lens with a tinted edge pattern and the control will be single vision contact lens with no tinted edge pattern. This study will recruit emmetropic and myopic participants. Emmetropic participants will wear plano power contact lenses and myopic participants will wear powered contact to correct their myopia. Participants will attend one single visit.
The study will comprise one visit with a total duration of approximately 80 minutes. All measurements will be performed by an optometrist. The initial measurements are performed prior to contact lens insertion, and comprise the photopic negative response (PhNR), pattern electroretinogram (PERG), and axial length. Contact lenses will be inserted after these measurements are taken. Participants will wear contact lenses and watch a greyscale television at 4 m in a room with an illumination of 700 lux for 10 minutes, after which the PhNR will be measured while wearing contact lenses. Participants will continue wearing contact lenses and watch a greyscale television at 4 m in a room with an illumination of 700 lux for a further 40 minutes, after which the PhNR and PERG will then be measured while wearing contact lenses. Adherence to watching the greyscale television will be monitored by research staff. Contact lenses will be removed, and the axial length will be measured.
Query!
Intervention code [1]
326392
0
Treatment: Devices
Query!
Comparator / control treatment
The control contact lens will be a standard single vision contact lens, i.e., the control lens will not have a tinted edge pattern..
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
335188
0
Difference in PhNR between eyes. PhNR will be measured using a standard electro-retinographer.
Query!
Assessment method [1]
335188
0
Query!
Timepoint [1]
335188
0
Time 0 (prior to contact lens insertion)
Approximately 10 minutes after contact lens insertion (while wearing contact lenses).
Approximately 50 minutes after contact lens insertion (while wearing contact lenses).
Query!
Secondary outcome [1]
423420
0
Difference in PERG between eyes. PERG will be measured using a a standard electro-retinographer.
Query!
Assessment method [1]
423420
0
Query!
Timepoint [1]
423420
0
Time 0 (prior to contact lens insertion)
Approximately 50 minutes after contact lens insertion (while wearing contact lenses).
Query!
Secondary outcome [2]
424194
0
Axial length
Difference in axial length between eyes. Axial length will be measured using a standard ocular biometer.
Query!
Assessment method [2]
424194
0
Query!
Timepoint [2]
424194
0
Time 0 (prior to contact lens insertion)
Approximately 50 minutes after contact lens insertion (contact lenses removed before measurement).
Query!
Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be aged 18-25 (inclusive) male or female.
Willing to comply with the clinical trial as directed by the Investigator.
Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses.
*Have a spherical equivalent refraction of <-0.75D (myopic group) OR between +/-0.50D (non-myopic group)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
25
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Refractive error (myopia, hyperopia or astigmatism) greater than 3D
Difference of refractive error between the eye greater than 1D
Any history of significant eye injury or surgery
Any major systemic disease
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
All participants will wear one test and one control contact lens simultaneously. The eye in which each the test and control is worn will be randomly determined.
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
A pilot study conducted at Flinders University showed the mean difference in PhNR between eyes while wearing test and control contact lenses to be 0.888 micro volts with a standard deviation of 1.214 micro volts. If this is a true difference between test and control, this study requires 30 participants to wear the test and control in each eye to be able to reject the null hypothesis with 80% power. The Type I error is set at 0.05.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
31/08/2023
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
18/09/2023
Query!
Actual
Query!
Date of last data collection
Anticipated
18/09/2023
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment postcode(s) [1]
40634
0
5042 - Flinders University
Query!
Funding & Sponsors
Funding source category [1]
314151
0
Commercial sector/Industry
Query!
Name [1]
314151
0
nthalmic Pty Ltd
Query!
Address [1]
314151
0
Suite L2, Level 3, Lakes Business Park,
2A Lord St,
Botany NSW 2019
Query!
Country [1]
314151
0
Australia
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
nthalmic Pty Ltd
Query!
Address
Suite L2, Level 3, Lakes Business Park,
2A Lord St,
Botany NSW 2019
Query!
Country
Australia
Query!
Secondary sponsor category [1]
316070
0
None
Query!
Name [1]
316070
0
Query!
Address [1]
316070
0
Query!
Country [1]
316070
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
313286
0
Human Research Ethics Committee, Flinders University
Query!
Ethics committee address [1]
313286
0
Flinders University
Sturt Road, Bedford Park, South Australia, 5042
GPO Box 2100, Adelaide, South Australia, 5001
Query!
Ethics committee country [1]
313286
0
Australia
Query!
Date submitted for ethics approval [1]
313286
0
24/10/2022
Query!
Approval date [1]
313286
0
16/11/2022
Query!
Ethics approval number [1]
313286
0
5781
Query!
Summary
Brief summary
The purpose of this study is to assess the retinal function and axial length of a prototype contact lens with a line edge pattern compared to a commercially available single vision contact lens.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
127606
0
Dr Ranjay Chakraborty
Query!
Address
127606
0
College of Nursing and Health Science
Flinders University
Sturt Road, Bedford Park, SA 5042
Query!
Country
127606
0
Australia
Query!
Phone
127606
0
+618 7221 8708
Query!
Fax
127606
0
Query!
Email
127606
0
[email protected]
Query!
Contact person for public queries
Name
127607
0
Ms Jennie Diec
Query!
Address
127607
0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park,
2A Lord St.
Botany NSW 2019
Query!
Country
127607
0
Australia
Query!
Phone
127607
0
+61 2 9037 7700
Query!
Fax
127607
0
Query!
Email
127607
0
[email protected]
Query!
Contact person for scientific queries
Name
127608
0
Dr Daniel Tilia
Query!
Address
127608
0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park,
2A Lord St.
Botany NSW 2019
Query!
Country
127608
0
Australia
Query!
Phone
127608
0
+61 2 9037 7700
Query!
Fax
127608
0
Query!
Email
127608
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Individual participant data will not be published. However, trial results, recorded as group means plus/minus SD and their statistical analysis may be published in scientific journals
Query!
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.
Download to PDF