Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000908639
Ethics application status
Approved
Date submitted
8/08/2023
Date registered
23/08/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
23/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the visual performance of novel myopia management spectacles in short-sighted young adults
Scientific title
Prospective, single-masked, randomised, bilateral wear, dispensing trial to assess the visual performance of novel myopia management spectacle lenses in myopic adults.
Secondary ID [1] 310267 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 330952 0
Condition category
Condition code
Eye 327756 327756 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a prospective, bilateral, randomised, single-masked (participant), cross-over clinical trial. Participants will wear up to 9 different test spectacles and one control spectacle (i.e., 10 study spectacles in total). All test spectacles are configured with peripheral optical features comprising lights words and axicons in different orientations comprising spoke, radial, and spiral patterns (or combinations of these patterns), and different configurations of axicons or light swords in the mid-periphery to the periphery of the spectacle lens, that are hypothesized to reduce the rate of myopia progression. The orientation and configurations of the optical features are configured differently between the 9 test designs and will be known as P1 through to P9. Test spectacle lenses are made of polycarbonate material and are to be worn for up to 5 days for a minimum of 6 hours / day. There is no limit to the maximum number of hours spectacles are worn.
Participants will choose a spectacle frame and all 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 a new frame for each study spectacle, but an identical frame same model, size, and colour), the same prescription, and the same optical centration will be used for each study spectacle.
Each participant will attend for up to 5 visits, depending on the number of study spectacles that are worn. Assuming a participant wears 10 study spectacles (9 test, one control), they will attend for 5 visits comprising visit 1 (baseline), visit 2 (1st set of spectacle lens dispensed), visit 3 (1st spectacle lens collection and 2nd set of spectacle lens dispensed), visit 4 (2nd spectacle lens collection and 3rd set of spectacle lens dispensed) and visit 5 (3rd spectacle lens collection). Up to four study spectacles will be dispensed at visits 2, 3 and 4. There will be no study spectacles given at baseline (visit 1) as this is the first visit, nor at 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 2-3 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 dispensing visits (visits 2-4) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Spectacle collection visits will involve only the collection of used study spectacles.
All assessments will be carried out by an optometrist.
Participants will be instructed to wear allocated study spectacles for up to 5 days, and a minimum of 6 hours per day.
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 study spectacle has been worn for 3 days.
Intervention code [1] 326643 0
Treatment: Devices
Comparator / control treatment
The control will be current commercially available myopia management spectacles.
Control group
Active

Outcomes
Primary outcome [1] 335554 0
Difference in subjective visual performance ratings between the control spectacle and each test spectacle. Participants will be asked to rate their vision with each spectacle lens on a non-validated 1-10 numeric rating scale.
Timepoint [1] 335554 0
Following Visit 2 (approximately 2 weeks post enrolment): at Day 3, Day 8, Day 13, Day 18 post Visit 2
Following Visit 3 (approximately 5 weeks post enrolment): at Day 3, Day 8, Day 13, Day 18 post Visit 3
Following Visit 4 (approximately 8 weeks post enrolment): at Day 3, Day 8, Day 13, Day 18 post Visit 4
Secondary outcome [1] 424937 0
Difference in visual acuity measures between the control spectacle and each test spectacle. Visual acuity will be measured with standard logMAR chart at 6 metres, 70 cm, and 40 cm. Visual acuities at different distances will be assessed as a composite outcome.
Timepoint [1] 424937 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] 424938 0
Difference in distance and near phoria between the control spectacle and each test spectacle. Distance and near phoria will be measured using the modified Thorington technique.
Distance and near phoria will be assessed as a composite outcome.
Timepoint [2] 424938 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 at least 18 years old and less than 45 years (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 wearing spectacle lenses.
Currently wearing or have the need to wear single-vision spectacles to correct myopia.
Meet the following criteria based on subjective refraction at Baseline:
Spherical equivalent less than or equal to -0.50 D
Spherical component between -6.00 DS and 0 DS (inclusive).
Astigmatic component between -2.00 DC and 0 DC (inclusive).
Achieves at least 0.10 logMAR in each eye at 6 m and binocularly at 40 cm while wearing subjective distance refraction.
Minimum age
18 Years
Maximum age
45 Years
Sex
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 ocular 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
This study is to compare the difference in subjective visual performance between each Test and the Control. Based on a review of the literature, it is assumed that that the difference between each Test and Control is a clinically relevant 1.0 unit and the SD = 1.8 units. A minimum available power of 80% based on a t-test (two-sided) is required for each comparison, and it is assumed that 9 tests will be assessed. Therefore, the sample size calculation for the type I error is set at the level of 0.00556 (0.05/9) for each comparison to account for the multiple comparisons, and 47 participants are needed to wear each study spectacle. Assuming a 10% drop-out, a minimum of 53 participants are required to be enrolled. If fewer than 9 tests are assessed, the required sample will be adjusted appropriately using the same described methodology.
The primary endpoint is the difference in subjective ratings after at least 3 days of wear between each Test and the Control. Data from multiple visits are available for the analysis. Therefore, to account for the correlation of data collected within the same participant, a random effects mixed model will be used to compare the primary endpoint over the study period. Participant will be included as random effects in the model to account for the correlation between repeated measures and within the same participant. The difference in subjective ratings after at least 3 days of wear its two-sided 95% confidence intervals at each assessment visit will be estimated from the model, and significance will be set at the 5% level.
The secondary endpoints include the difference between each Test and the Control for visual acuity performance and phoria measurements. Depending on the actual variables measured (continuous data), a similar random effects mixed model to the primary endpoint will be used for the analysis. Where data is available from two eyes (e.g., monocular visual acuity measurements), participant and eye (nested within participant) will be included as random effects in the model to account for the correlation between repeated measures and between eyes within the same participant. The results from secondary endpoints will provide supportive evidence.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/10/2023
Actual
19/10/2023
Date of last participant enrolment
Anticipated
18/09/2024
Actual
Date of last data collection
Anticipated
18/12/2024
Actual
Sample size
Target
53
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40976 0
2019 - Botany

Funding & Sponsors
Funding source category [1] 314474 0
Commercial sector/Industry
Name [1] 314474 0
Shanghai iSparX Medical Ltd
Country [1] 314474 0
China
Primary sponsor type
Commercial sector/Industry
Name
Shanghai iSparX Medical Ltd
Address
A316, No.189 Xinjun Ring Road
Minhang District
Shanghai China 201114
Country
China
Secondary sponsor category [1] 316424 0
Commercial sector/Industry
Name [1] 316424 0
nthalmic Pty Ltd
Address [1] 316424 0
Suite L2, Level 3, Lakes Business Park,
2A Lord St,
Botany NSW 2019
Country [1] 316424 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313525 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313525 0
Ethics committee country [1] 313525 0
Australia
Date submitted for ethics approval [1] 313525 0
08/08/2023
Approval date [1] 313525 0
07/09/2023
Ethics approval number [1] 313525 0
2023-08-926

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

Contacts
Principal investigator
Name 128446 0
Dr Daniel Tilia
Address 128446 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 128446 0
Australia
Phone 128446 0
+61 2 9037 7700
Fax 128446 0
Email 128446 0
[email protected]
Contact person for public queries
Name 128447 0
Kathleen Laarakkers
Address 128447 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 128447 0
Australia
Phone 128447 0
+61 2 9037 7700
Fax 128447 0
Email 128447 0
[email protected]
Contact person for scientific queries
Name 128448 0
Daniel Tilia
Address 128448 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019
Country 128448 0
Australia
Phone 128448 0
+61 2 9037 7700
Fax 128448 0
Email 128448 0
[email protected]

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 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.