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Trial registered on ANZCTR


Registration number
ACTRN12621001264875p
Ethics application status
Submitted, not yet approved
Date submitted
2/08/2021
Date registered
17/09/2021
Date last updated
17/09/2021
Date data sharing statement initially provided
17/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the visual performance of spectacle films in short-sighted young adults
Scientific title
Prospective, single-masked, randomised, bilateral wear, dispensing trial to assess the visual performance of spectacle films in myopic young adults
Secondary ID [1] 304451 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 322268 0
Condition category
Condition code
Eye 319951 319951 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomised, single-masked (participant), cross-over clinical trial. Participants will wear 11 different test spectacles with lens films and control spectacles. All the test films are configured with peripheral optical features to purposefully create peripheral retinal defocus, which has been shown to reduce the rate of myopia progression when applied to both spectacles and contact lenses. The location of the optical features within the films are configured differently between the 11 test designs, both in terms of the number of optical features contained in each film and in the orientation and placement of each optical feature. One example of the test design is D1O2, where D1 denotes the design number of the optical features and O2 denotes the orientation and placement of the optical features. The final pair of test films within the spectacles is then known as N1 through to N11. The lens films will be specifically designed for this trial by nthalmic. Lens films are made of polycarbonate material and are visually clear. All spectacles will be worn for up to 5 days for a minimum of 6 hours/day, there is no limit to the maximum hours spectacles are worn.
Participants will choose a frame design from a designated pool of standard test frames. Fittings will be confirmed by an optometrist. The distance power of the spectacle lenses will be power-matched to the participant's myopic refractive error. Participants will be dispensed new frames and lenses for each test, but each participant will use the same model and size frame with the same prescription for each lens film.
Each participant will attend for a maximum of 5 visits, comprising visit 1 (baseline), visit 2 (1st spectacle lens dispense), visit 3 (1st spectacle lens collection and 2nd spectacle lens dispense), visit 4 (2nd spectacle lens collection and 3rd spectacle lens dispense) and visit 5 (3rd spectacle lens collection). Four spectacles will be dispensed at visits 2, 3 and 4. There will be no spectacles given at baseline or visit 5 as this is the final spectacle collection visit.
Visit 1, 3 and 4 will be approximately 60min duration and visit 2 and visit 5 will be approximately 30min duration. The timing between visits will be approximately 3 weeks apart.
Visit 1 will comprise standard subjective refraction and measurement of visual acuity obtained with refraction. A standard logMAR visual acuity chart will be used. Spectacle lens dispense visits will include visual acuity measurements using standard logMAR visual acuity charts. Spectacle lenses will be dispensed. Spectacle collection visits will involve only the collection of used spectacles.
All assessments will be carried out by an optometrist.
Participants will be instructed to wear allocated spectacle lenses as per the schedule and return all spectacles.
There is no 'wash-out' period between treatments.
Compliance will be assessed by verbal questioning of participants.
Questionnaires will be administered to participants after each spectacle lens wear.
Intervention code [1] 320796 0
Treatment: Devices
Comparator / control treatment
There is one control in this trial: spectacle lenses with film with no optical features. This control spectacle film will be designed by nthalmic and is made of polycarbonate material. The film has no non-optical features..
Control group
Active

Outcomes
Primary outcome [1] 327830 0
Subjective visual performance ratings between test and control spectacle films. Participants will be asked to rate their vision with each spectacle lenses on a non-validated 1-10 numeric rating scale
Timepoint [1] 327830 0
Following visit 2 (approximately 2 weeks post-enrolment): at 3 days, 8 days, 13 days and 18 days post visit 2 - primary timepoint
Following visit 3 (approximately 5 weeks post-enrolment): at 3 days, 8 days, 13 days and 18 days post visit 3 - primary timepoint
Following visit 4 (approximately 8 weeks post-enrolment): at 3 days, 8 days, 13 days and 18 days post visit 4 - primary timepoint
Secondary outcome [1] 396712 0
Visual acuity measures between test and control spectacle films. Visual acuity will be measured with standard logMAR chart at 6m
Timepoint [1] 396712 0
Visit 2: (approximately 2 weeks post-enrolment)
Visit 3: (approximately 5 weeks post-enrolment)
Visit 4: (approximately 8 weeks post-enrolment)
Secondary outcome [2] 398871 0
Binocular vision between test and control spectacle films.
Binocular vision assessments comprise the measurement of distance and near phoria and will be measured using the modified Thorington technique.
Timepoint [2] 398871 0
Visit 2: (approximately 2 weeks post-enrolment)
Visit 3: (approximately 5 weeks post-enrolment)
Visit 4: (approximately 8 weeks post-enrolment)
Secondary outcome [3] 399794 0
Contrast sensitivity measures between test and control spectacle films.
Contrast sensitvitiy will be measured using a standard Pelli-Robson contrast sensitivity letter chart.
Timepoint [3] 399794 0
Visit 2: (approximately 2 weeks post-enrolment)
Visit 3: (approximately 5 weeks post-enrolment)
Visit 4: (approximately 8 weeks post-enrolment)

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be greater than or equal to 18 years old but less than 40 years old, 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 wearing spectacle lenses.
Have myopia greater than 0.75 D
Have no more than 2.00DC of astigmatism.
Have best-corrected visual acuity at least 6/7.5.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would cause vision fluctuations.
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.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery .
Known allergy or intolerance to ingredients in spectacle frames .
Currently enrolled in another clinical trial.
Pregnancy at time of enrolment - verbal report sufficient
The Investigator may, at their 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.

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Each test spectacle lens film will be compared to one control. To demonstrate a statistically significant paired difference of 1.0 ± 1.5 units on a 1-10 numeric rating scale, and 5% significance, a sample of 39 participants will have > 80% power to allow comparisons between each test and the control spectacle film. The sample size is adjusted for a 10% drop-out.
Primary and secondary outcomes will be summarised as means ± standard deviation. Variable will be compared between the control and each test lens using parametric paired t-tests if the assumptions of data normality are not violated. Otherwise, Wilcoxon signed-rank test may be used. Multiple comparisons between all lens types will be assessed with descriptive statistics.

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
Recruitment postcode(s) [1] 34337 0
2019 - Botany

Funding & Sponsors
Funding source category [1] 308811 0
Commercial sector/Industry
Name [1] 308811 0
nthalmic Pty Ltd
Address [1] 308811 0
Suite L2, Level 3, Lakes Business Park
2A Lord Street
Botany NSW 2019
Country [1] 308811 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
nthalmic Pty Ltd
Address
Suite L2, Level 3, Lakes Business Park
2A Lord Street
Botany NSW 2019
Country
Australia
Secondary sponsor category [1] 309730 0
None
Name [1] 309730 0
Address [1] 309730 0
Country [1] 309730 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308725 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 308725 0
123 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 308725 0
Australia
Date submitted for ethics approval [1] 308725 0
04/08/2021
Approval date [1] 308725 0
Ethics approval number [1] 308725 0

Summary
Brief summary
The purpose of this trial is to compare the visual performance of various spectacle films (test) against films without optical features (control). Visual performance will be assessed with vision testing and questionnaires completed by the participant. The films are made of polycarbonate material and have been designed to provide optical features for the use by people with short-sightedness. It is hypothesized the visual performance of test films will be no different to the control film.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111674 0
Mr Daniel Tilia
Address 111674 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park
2A Lord Street
Botany NSW 2019
Country 111674 0
Australia
Phone 111674 0
+61 02 9037 7700
Fax 111674 0
Email 111674 0
d.tilia@nthalmic.com
Contact person for public queries
Name 111675 0
Ms Kathleen Laarakkers
Address 111675 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park
2A Lord Street
Botany NSW 2019
Country 111675 0
Australia
Phone 111675 0
+61 02 9037 7700
Fax 111675 0
Email 111675 0
k.laarakkers@nthalmic.com
Contact person for scientific queries
Name 111676 0
Mr Daniel Tilia
Address 111676 0
nthalmic Pty Ltd
Suite L2, Level 3, Lakes Business Park
2A Lord Street
Botany NSW 2019
Country 111676 0
Australia
Phone 111676 0
+61 02 9037 7700
Fax 111676 0
Email 111676 0
d.tilia@nthalmic.com

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 be published. However trial results, recorded as group means plus / minus SD and their statistical analysis may be published in scientific journals
What supporting documents are/will be available?
No other documents available
Summary results
No Results