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Trial registered on ANZCTR


Registration number
ACTRN12619001057178
Ethics application status
Approved
Date submitted
17/07/2019
Date registered
29/07/2019
Date last updated
21/04/2023
Date data sharing statement initially provided
29/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of contrast sensitivity function with optical filters, myopia control spectacles and contact lenses in myopes
Scientific title
A prospective, cross-over trial to determine the effect of optical filters, myopia control spectacles and contact lenses on the contrast sensitivity function
Secondary ID [1] 298469 0
None
Universal Trial Number (UTN)
U1111-1235-1203
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contrast sensitivity 313236 0
Condition category
Condition code
Eye 311677 311677 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, cross-over clinical trial to determine the effect of filters, myopia control spectacles and soft contact lenses on the contrast sensitivity function. Up to 30 prototype designs may be assessed during the study. Up to 20 participants (minimum of 10) will be included in the evaluation of each prototype design. The contrast sensitivity function (plotting of contrast thresholds at various spatial frequencies) obtained with filters, myopia control spectacles and soft contact lenses will be compared to the contrast sensitivity function obtained with single vision spectacles and soft contact lenses.
Healthy adults aged at least 18 years old will be recruited. Habitual spectacle wearers, experienced and inexperienced contact lens wearers will be recruited
Intervention code [1] 314709 0
Treatment: Devices
Comparator / control treatment
Control treatment remains the same but not divided into Arm 1 and Arm 2. Participants can go for one or both control treatments.
Control group
Active

Outcomes
Primary outcome [1] 320377 0
Contrast sensitivity threshold at low frequency with different study products. Contrast sensitivity will be measured with an in-house written software. Participants will be asked to detect spatially filtered letters/sine wave grating images at different spatial frequencies and contrasts on a computer monitor.
Timepoint [1] 320377 0
Approximately 2 hours after putting on each study product.
Primary outcome [2] 320815 0
Contrast sensitivity threshold at medium spatial frequency with different study products. Contrast sensitivity will be measured with an in-house written software. Participants will be asked to detect spatially filtered letters/sine wave grating images at different spatial frequencies and contrasts on a computer monitor.
Timepoint [2] 320815 0
Approximately 2 hours after putting on each study product
Primary outcome [3] 320816 0
Contrast sensitivity threshold at high spatial frequency with different study products. Contrast sensitivity will be measured with an in-house written software. Participants will be asked to detect spatially filtered letters/sine wave grating images at different spatial frequencies and contrasts on a computer monitor.
Timepoint [3] 320816 0
Approximately 2 hours after putting on each study product
Secondary outcome [1] 371404 0
Area under log contrast sensitivity function with different study products. This is a summary statistic of the primary outcome.
Timepoint [1] 371404 0
Approximately 2 hours after putting on each study product.

Eligibility
Key inclusion criteria
Be at least 18 years, male or female.
Astigmatism less than or equal to -2.00 D in both eyes.
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Willing to comply with the wearing and clinical trial visit schedule 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.
Is correctable to at least 6/7.5 (20/25) or better in right eye with or without correction
Be habitual spectacle wearers, experienced or inexperienced contact lens wearers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
.• Have strabismus and/or amblyopia.
• Astigmatism more than- 2.00 D in either eye.
• Any ocular and central nervous system anomalies.
• Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
• Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
• Eye surgery within 12 weeks prior to enrolment for this trial.
• Previous corneal refractive surgery.
• Known allergy or intolerance to ingredients in any of the clinical trial products.
• Currently enrolled in another clinical trial.
• Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
• Pregnancy*.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A previous study that compared contrast sensitivity using multifocal contact lenses showed that the variability in distance Log-Contrast Sensitivity ranged from 0.21 to 0.28 and averaged at 0.25 logCS. The paired difference of multifocal CL to single vision CL ranged from 0.24 to 0.43 logCS. Similarly the variability of near contrast sensitivity was 0.1 and the difference ranged from 0.1 to 0.16 logCS. A minimum sample of 15 subjects will have 80% power to detect a paired difference of 0.25±0.25 distance logCS and 0.1±0.1 near logCS at the 5% level of significance after Bonferroni adjustment to post - hoc multiple comparisons. The sample to enrol is increased to 17 subjects per study arm (CL and Specs) to account for a 10% drop out rate, resulting in a total minimal sample of 34 participants.

Contrast thresholds at low, medium and high spatial frequencies will be summarised as mean ± standard deviation. Log transformation will be applied if normality of data cannot be assumed using test of normality. Contrast thresholds of experienced contact lens wearers wearing myopia control contact lenses and optical filters will be compared with single vision soft contact lenses using repeated measures ANOVA. Similarly, contrast thresholds at low, medium and high spatial frequencies of habitual spectacle wearers wearing myopia control spectacles will be compared with single vision spectacles using repeated measures ANOVA. Crossed over treatments, spatial frequency and eyes will be factored as within-subject factors.

Likewise, area under log contrast sensitivity function (AULCSF) will be summarised as mean ± standard deviation. Log transformation will be applied if normality of data cannot be assumed using test of normality. AULCSF with myopia control contact lenses and optical filters will be compared with single vision soft contact lenses using repeated measures ANOVA. Area under log contrast sensitivity function (AULCSF) with myopia control spectacles and optical filters will be compared with single vision spectacles using repeated measures ANOVA. Crossed over treatments, spatial frequency and eyes will be factored as within-subject factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
8/01/2021
Date of last participant enrolment
Anticipated
28/07/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
50
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303012 0
Commercial sector/Industry
Name [1] 303012 0
Brien Holden Vision Institute Limited
Country [1] 303012 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brien Holden Vision Institute Limited
Address
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 302987 0
None
Name [1] 302987 0
Address [1] 302987 0
Country [1] 302987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303563 0
Bellberry Limited
Ethics committee address [1] 303563 0
Ethics committee country [1] 303563 0
Australia
Date submitted for ethics approval [1] 303563 0
30/05/2019
Approval date [1] 303563 0
09/07/2019
Ethics approval number [1] 303563 0

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

Contacts
Principal investigator
Name 94098 0
Mr Dean Psarakis
Address 94098 0
Level 4, North Wing, Rupert Myers Building Gate 14, Barker Street UNSW Sydney NSW 2052
Country 94098 0
Australia
Phone 94098 0
+61 2 93857516
Fax 94098 0
Email 94098 0
d.psarakis@bhvi.org
Contact person for public queries
Name 94099 0
Luke Seesink
Address 94099 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 94099 0
Australia
Phone 94099 0
+61 2 93855934
Fax 94099 0
Email 94099 0
l.seesink@bhvi.org
Contact person for scientific queries
Name 94100 0
Dean Psarakis
Address 94100 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Country 94100 0
Australia
Phone 94100 0
+61 2 93854401
Fax 94100 0
Email 94100 0
d.psarakis@bhvi.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not published. However trial results, recorded as group means plus/minus SD and their statistical analysis may be published in scientific journals, and may be provided to individuals upon reasonable request.


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.