Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

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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
29/07/2019
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
Arm 1:
This arm consists of habitual spectacle wearers. During the study they will wear single vision spectacle lenses, and myopia control spectacle lenses (Myosmart, Myovision). The lens power of each product will be based on the spherical equivalent of the best-corrected subjective refraction found at baseline. Occasionally the myopia control spectacle lenses may need to be worn with contact lenses to provide the correct power depending on available stock. These products will only be worn at the scheduled study visits, for approximately 2-3 hours each, and administered by investigators who are qualified optometrists. A washout of at least 2 nights will occur between testing each study product. Contrast sensitivity function will be measured with each study product. Participants will be asked to detect spatially filtered letters/sine wave grating images at different spatial frequencies and contrasts on a computer monitor at both 6 m distance and 40 cm distance.
Arm 2:
This arm consists of experienced contact lens wearers. During the study they will wear single vision soft contact lenses, myopia control contact lenses (MiSight, MYLO, Proclear Multifocal), and optical filters (Bangerter filters) of two different densities over single vision contact lenses. The lens power of each product will be based on the spherical equivalent of the best-corrected subjective refraction found at baseline. These products will only be worn at the scheduled study visits, for approximately 2-3 hours each, and administered by investigators who are qualified optometrists. A washout of at least 2 nights will occur between testing each study product. Contrast sensitivity function will be measured with each study product. Participants will be asked to detect spatially filtered letters/sine wave grating images at different spatial frequencies and contrasts on a computer monitor at both 6 m distance and 40 cm distance.
Intervention code [1] 314709 0
Treatment: Devices
Comparator / control treatment
Arm 1: Single vision spectacle lenses
Arm 2: Single vision contact lenses (1-Day Acuvue Moist)
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
Age in complete years ranging from 18 to 35 years, male or female.
Sphere -0.50 D to -4.00 D with cylinder no more than -0.50 D; anisometropia of less than or equal to 1.50D
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 6/12 (20/40) or better in each eye with or without correction.
Habitual spectacle wearers and experienced contact lens wearers.
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
At baseline, be anisometropic by more than 1.50D.
Have strabismus and/or amblyopia.
At baseline, astigmatism more than -0.50 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, Sjogrens 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*.
The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
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
Address [1] 303012 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
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
123 Glen Osmond Rd
Eastwood
South Australia 5063
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
This is a trial to determine the effect of filters, myopia control spectacles and soft contact lenses on the contrast sensitivity function. The contrast sensitivity function 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94098 0
Ms Jennifer Sha
Address 94098 0
Level 5, 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
j.sha@brienholdenvision.org
Contact person for public queries
Name 94099 0
Ms Kassandra Wagenfuehr
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
k.wagenfuehr@brienholdenvision.org
Contact person for scientific queries
Name 94100 0
Ms Krupa Philip
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
k.philip@brienholdenvision.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 other documents available
Summary results
No Results