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Trial registered on ANZCTR


Registration number
ACTRN12623000616673p
Ethics application status
Not yet submitted
Date submitted
17/05/2023
Date registered
5/06/2023
Date last updated
14/06/2023
Date data sharing statement initially provided
5/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Adherence to myopia control spectacle lens wear in children aged 7 to 12: a comparison of two lens designs.
Scientific title
Adherence to myopia control spectacle lens wear in children aged 7 to 12: a comparison of two lens designs.
Secondary ID [1] 309615 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MCSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 329935 0
Condition category
Condition code
Eye 326841 326841 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants aged 7-12 with myopia will be assigned to wear one of two types of myopia control spectacle lenses for one year, either Defocus Incorporated Multiple Segment (DIMS) or Highly Aspheric Lenslet Target (HALT) lenses. The aims of this study are to measure and compare adherence to the treatment between the DIMS and HALT groups, monitor adaptation and to identify barriers to full time wear.

Participants will attend 6 visits (each 30 to 90 minutes long) at the University of Auckland Eye Clinic at the Faculty of Medical and Health Sciences over a one year period. The visits will occur at Baseline, 2 weeks after baseline for spectacle collection, 1 month, 6 months, 7 months and 12 months from spectacle collection.

Visit 1 (60 minutes): Baseline/Dispensing appointment. The dispensing appointment will occur after a baseline eye examination (as part of the patient's routine optometric care). The participant will choose a frame and the measurements necessary to manufacture the DIMS or HALT lenses will be taken (monocular centration distances using a pupilometer and vertical heights using a pen torch and ruler. The parent or guardian will be asked to complete a questionnaire to obtain information on the history of spectacle wear. Axial lengths and the spectacle prescription will be retrieved for the participants clinical records with consent.

Visit 2 (30 minutes): Spectacle Collection. Participant will collect the glasses 2 to 3 weeks after visit 1 and visual acuities will be assessed using a Snellen chart a 6 metres and near vision chart. Lens centration over the pupil will be assessed and frame adjustments will be made where necessary.

Visit 3 (30 minutes): 1 month from spectacle collection. The parent or guardian will be asked to complete a questionnaire on spectacle adherence, adaptation to the lens design and factors preventing full-time wear. Spectacle fitting will be assessed and frames will be adjusted or repaired where necessary.

Visit 4 (60 minutes): 6 months from spectacle collection. This appointment will follow the patient's routine 6 month eye examination. The parent or guardian will complete a questionnaire on spectacle adherence, adaptation to the lens design and factors preventing full time wear. Visual acuities will be measured using a Snellen chart at 6m and a near vision chart, and lens centration over the pupil will be assessed. Frame adjustments will be made where necessary. Axial lengths and the spectacle prescription will be obtained from the patient's clinical records. A SpecsOn temperature device will be fixed to the frame and will be used over the next 3 weeks to sample adherence to the treatment. This device is a non-invasive, non-emitting electronic device that measures skin and ambient temperature. The temperature differential will be used to determine when the glasses are being worn.

Visit 5 (30 minutes): 3 weeks from visit 4. This appointment is for the removal of the SpecsOn temperature sensor. Data will be retrieved from the device and the participant will wear the glasses without the sensor for the rest of the study. Spectacle fitting will be assessed and frame adjustments or repairs will be made where necessary.

Visit 6 (60 minutes): 12 months from spectacle collection. This appointment will follow the patient's routine 12 month eye examination. The parent or guardian will complete a questionnaire on spectacle adherence, adaptation to the lens design and factors preventing full time wear. Visual acuities will be measured using a Snellen chart at 6 metres and a near vision chart, and lens centration over the pupil will be assessed. Frame adjustments will be made where necessary. Axial lengths and the spectacle prescription will be obtained from the patient's clinical records.

Parents or guardians will be asked to report the number of hours their wears their glasses on 8 separate days spread throughout the year, 4 days during school holidays and 4 days during term time. Parents or guardians will be asked to report the number of hours via an online form and will be notified the day before the form is sent.

A Dispensing Optician will dispense the spectacles, administer the questionnaires and collect adherence and adaptation data. The spectacle prescription and axial lengths will be measured during routine eye examinations at the University of Auckland Eye Clinic and this data will be retrieved from the patient record with consent.
Intervention code [1] 326038 0
Treatment: Devices
Comparator / control treatment
Adherence, adaptation and factors affecting adherence will be compared between DIMS and HALT spectacle lens designs.
Control group
Active

Outcomes
Primary outcome [1] 334686 0
Spectacle wear adherence as determined by daily parental reporting using recording sheets specifically designed for this study
Timepoint [1] 334686 0
Parents or guardians will record the number of hours their child wear the glasses each day. Recording sheets will be collected at 6 months and 12 months (primary timepoint) from spectacle collection .
Primary outcome [2] 334687 0
Spectacle wear adherence as measured using SpecsOn temperature sensor
Timepoint [2] 334687 0
at 6 months from spectacle collection for a duration of 4 weeks
Secondary outcome [1] 421667 0
Barriers to full-time spectacle wear as assessed by a questionnaire designed specifically for this study.
Timepoint [1] 421667 0
At 6 months and 12 months from spectacle collection
Secondary outcome [2] 422402 0
Lens adaptation as assessed by questionnaires specifically designed for this study
Timepoint [2] 422402 0
At spectacle collection, 1 month, 6 months and 12 months from spectacle collection
Secondary outcome [3] 422403 0
Changes in axial length using a Lenstar Optical Biometer.
Timepoint [3] 422403 0
at baseline, 6 months and 12 months from initial eye examination

Eligibility
Key inclusion criteria
• Children aged 7-12
• Spherical equivalent refractive error: -1.00 to -4.00D
• Astigmatism: equal to or less than -1.50DC
• Anisometropia: equal to or less than 1.00D
• Acceptance of random group allocation
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current and previous myopia control treatments
• Other ocular or systemic disease, or surgery likely to affect myopia progression
• Strabismus or binocular vision abnormalities

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 will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample size of 25 in both the DIMS and HALT group (total 50) is desired for this study. This study will use SpecsOn monitoring to measure adherence to myopia control spectacles for the first time. Sample size is based on the practical number of myopic children who can be recruited through the University of Auckland Eye Clinic.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25433 0
New Zealand
State/province [1] 25433 0
Auckland

Funding & Sponsors
Funding source category [1] 313795 0
University
Name [1] 313795 0
University of Auckland
Country [1] 313795 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Optometry and Vision Science
85 Park Road
Grafton
Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 315717 0
None
Name [1] 315717 0
Address [1] 315717 0
Country [1] 315717 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312962 0
Northern B Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 312962 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 312962 0
New Zealand
Date submitted for ethics approval [1] 312962 0
30/06/2023
Approval date [1] 312962 0
Ethics approval number [1] 312962 0

Summary
Brief summary
The primary purpose of this study is to determine whether myopic children are wearing their prescribed myopia control spectacles for the recommended daily wearing time of 12 hours per day, and to compare adherence between two different myopia control spectacle lens designs, DIMS (commercially available as MiYOSMART™) and HALT (commercially available as Stellest™). The secondary purpose of this study is to identify any reasons or barriers which prevent children from wearing their myopia control glasses full time. We hypothesise that some children are not wearing their spectacles for the recommended wearing times due to lifestyle commitments, and that daily wearing times differ between the two lens designs. The results from the study can be used by optometrists and dispensing opticians to advise and support the parents of children prescribed myopia control glasses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126498 0
Ms Emily Benefer
Address 126498 0
School of Optometry and Vision Science
The University of Auckland
Faculty of Medical and Health Sciences
85 Park Road
Grafton
Auckland
1023
Country 126498 0
New Zealand
Phone 126498 0
+64 99239238
Fax 126498 0
Email 126498 0
[email protected]
Contact person for public queries
Name 126499 0
Emily Benefer
Address 126499 0
School of Optometry and Vision Science
The University of Auckland
Faculty of Medical and Health Sciences
85 Park Road
Grafton
Auckland
1023
Country 126499 0
New Zealand
Phone 126499 0
+64 99239238
Fax 126499 0
Email 126499 0
[email protected]
Contact person for scientific queries
Name 126500 0
Emily Benefer
Address 126500 0
School of Optometry and Vision Science
The University of Auckland
Faculty of Medical and Health Sciences
85 Park Road
Grafton
Auckland
1023
Country 126500 0
New Zealand
Phone 126500 0
+64 99239238
Fax 126500 0
Email 126500 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
IPD will not made available as the sponsor is not able to ensure appropriate ethics or data protection for the children's data.


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.