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Trial registered on ANZCTR


Registration number
ACTRN12619000538145
Ethics application status
Approved
Date submitted
28/03/2019
Date registered
4/04/2019
Date last updated
4/04/2019
Date data sharing statement initially provided
4/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding mechanism of progression of short-sightedness using progressive addition lenses
Scientific title
Impact of progressive addition lens spectacles on accommodation errors in young adults with short-sightedness
Secondary ID [1] 297367 0
Nil known
Universal Trial Number (UTN)
U1111-1230-6804
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia (Short-sightedness) 312172 0
Condition category
Condition code
Eye 310723 310723 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Short-sighted participants will be recruited from Queensland University of Technology and they will be provided with progressive addition lens spectacles to wear during waking hours. Progressive addition lenses contain a corridor of increasing power between distance and near zones, and are used to slow the worsening of myopia in children and young adults.
Two designs of the progressive addition lenses will be used. Type 1 is a conventional lens design with a wide corridor and type 2 is an interventional design with a narrow corridor. Participants will be followed up every three months for 12 months to measure the focussing error.

The principal investigator (PI), who is an optometrist, will perform refraction to check the power of the spectacles under supervision of A/Prof Katrina Schmid and Prof David Atchison in the Myopia Lab at the Queensland University of Technology. Then, the dispenser at the QUT optometry clinic verifies the segment heights measurements of the PI before ordering the spectacles.

The participants will be asked to wear the spectacle during usual waking hours. The prescription of spectacles for distance will be between -1.0 and -6.0 dioptre with the addition power of 1.50 D.

The focussing errors of the participants will be measured with the new spectacles at 0, 3, 6, 9 and 12 months timeline from the commencement of the intervention.

When the spectacles arrived from the lab, the prescription will be verified and the vision at far and near will be checked.

After spectacles are provided, the participants will be contacted via text or phone in a week to check the adaptation with the spectacles and duration of the spectacles wear. The participant will be contacted again after a month to assess the adaptation and duration of wearing hours.
Intervention code [1] 314050 0
Treatment: Devices
Comparator / control treatment
Active control treatment: Type 1, conventional lens design with a wide corridor and the addition power of +1.5 D.
Control group
Active

Outcomes
Primary outcome [1] 319566 0
Focusing error as assessed by a complete ophthalmic analysis system (COAS) aberrometer at 40, 33 and 25 cm..
Timepoint [1] 319566 0
12 months post intervention commencement
Secondary outcome [1] 368684 0
The focussing errors will be measured with a complete ophthalmic analysis system (COAS) aberrometer at 40, 33 and 25 cm.
Timepoint [1] 368684 0
0, 3, 6, and 9 months post intervention commencement

Eligibility
Key inclusion criteria
Short-sightedness
Minimum age
18 Years
Maximum age
27 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Person with other eye conditions such as glaucoma.
Spectacles power more than - 6.0 dioptre.
Anisometropia or astigmatism of more than 1.5 dioptre

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 involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We calculated a sample size of at least 25 people with short-sightedness in each group (50 for two groups) based on the following assumptions: an overall standard deviation (SD) of 0.64 D which is based on a previous study (Berntsen et al. 2011) and expected difference of 0.5 D between the two progressive addition lenses groups at the end of 12 months, two tailed a=0.05 and power =0.8. Given the possibility of 20% dropout, we aim to enrol no less than 60 myopes. The significance level for all statistical tests will be set to P <0.05. The sample size calculation was performed using the University of British Columbia online sample size calculator: https:// www.stat.ubc.ca/~rollin/stats/ssize/ n2.html

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)
QLD

Funding & Sponsors
Funding source category [1] 301935 0
University
Name [1] 301935 0
Institute of Health and Biomedical Sciences, Queensland University of Technology
Address [1] 301935 0
60 Musk Avenue, Kelvin Grove, 4059, QLD
Country [1] 301935 0
Australia
Funding source category [2] 302344 0
Commercial sector/Industry
Name [2] 302344 0
Carl Zeiss Vision Australia
Address [2] 302344 0
1284 South Road, Venture Road Off MAB Circuit
Tonsley
South Australia 5042
Country [2] 302344 0
Australia
Primary sponsor type
Individual
Name
A/Prof Katrina L Schmid
Address
School of Optometry and Vision Science, Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology
60 Musk Ave, Kelvin Grove, QLD, 4059, Australia
Country
Australia
Secondary sponsor category [1] 301690 0
Individual
Name [1] 301690 0
Prof David A Atchison
Address [1] 301690 0
School of Optometry and Vision Science, Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology
60 Musk Ave, Kelvin Grove, QLD, 4059, Australia
Country [1] 301690 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302617 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 302617 0
88 Musk Avenue, Kelvin Grove, 4059, QLD, Australia
Ethics committee country [1] 302617 0
Australia
Date submitted for ethics approval [1] 302617 0
19/12/2017
Approval date [1] 302617 0
26/07/2018
Ethics approval number [1] 302617 0
1800000390

Summary
Brief summary
Myopia (short-sightedness) is the most common vision problem in children. Higher amounts are associated with vision threatening diseases in later life. Progressive addition spectacle lens designs, used primarily in presbyopia, appear to slow down the development of juvenile myopia but their efficacy tends to weaken after a period of about 12 months. The aim of this project is to further the understanding of the accommodation system (the near focusing mechanism) and drivers of the progression of myopia to ultimately lead to more effective lens designs. This study will improve understanding of eye structure changes during accommodation and provide a fundamental investigation of accommodation mechanisms in myopia. It will potentially contribute to improved designs and use of lenses for the treatment of myopia in children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90834 0
Mr Dinesh Kaphle
Address 90834 0
School of Optometry and Vision Science, Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology
60 Musk Ave, Kelvin Grove, QLD, 4059, Australia
Country 90834 0
Australia
Phone 90834 0
+61 7 31386155
Fax 90834 0
Email 90834 0
dinesh.kaphle@hdr.qut.edu.au
Contact person for public queries
Name 90835 0
Mr Dinesh Kaphle
Address 90835 0
School of Optometry and Vision Science, Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology
60 Musk Ave, Kelvin Grove, QLD, 4059, Australia
Country 90835 0
Australia
Phone 90835 0
+61 7 31386155
Fax 90835 0
Email 90835 0
dinesh.kaphle@hdr.qut.edu.au
Contact person for scientific queries
Name 90836 0
A/Prof Katrina L Schmid
Address 90836 0
School of Optometry and Vision Science, Institute of Health and Biomedical Innovation, Faculty of Health, Queensland University of Technology
60 Musk Ave, Kelvin Grove, QLD, 4059, Australia
Country 90836 0
Australia
Phone 90836 0
+61 7 31386150
Fax 90836 0
Email 90836 0
k.schmid@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not think individual data would be useful. We do not have ethics approval for making IPD public.
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1748 0
Ethical approval
Citation [1] 1748 0
Link [1] 1748 0
Email [1] 1748 0
Other [1] 1748 0
Type [2] 1749 0
Informed consent form
Citation [2] 1749 0
Link [2] 1749 0
Email [2] 1749 0
Other [2] 1749 0
Summary results
No Results