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Trial registered on ANZCTR


Registration number
ACTRN12620000619943p
Ethics application status
Not yet submitted
Date submitted
5/05/2020
Date registered
28/05/2020
Date last updated
28/05/2020
Date data sharing statement initially provided
28/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the vision performance of spectacle lenses prescribed in smaller steps than standard spectacle lenses in adults who are short-sighted
Scientific title
A randomized, double masked, cross-over clinical trial to compare the vision performance of spectacles prescribed to 0.05D versus 0.25D steps in adults with myopia
Secondary ID [1] 301191 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 317337 0
Condition category
Condition code
Eye 315446 315446 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a prospective, bilateral, randomized, double-masked, cross-over clinical trial.
Participants will wear two single-vision spectacle lenses mounted in the same pair of frames for one week each.
The power of each single-vision spectacle lens is matched to correct the participant’s myopia. The difference between designs is the control spectacle lens is available in the traditional increments of 0.25 D while the test spectacle lens is available in finer increments of 0.05 D steps.
All spectacles will be worn daily.
There will four visits comprising visit 1 (Baseline), visit 2 (collection of first randomly allocated spectacles), visit 3 (assessment of first randomly allocated spectacles and collection of second randomly allocated spectacles), and visit 4 (assessment of second randomly allocated spectacles).
All visits will be performed by a masked investigator. Visit 1 will be approximately 90 minutes in duration, visit 3 approximately 60 minutes, and visits 2 and 4 approximately 30 minutes each.
Visit 1 will comprise subjective refraction in both 0.25 D and 0.05 D steps and measurement of visual acuity for both subjective refractions. Participants will be asked to rate their quality of vision with habitual spectacles on a numeric rating scale. The numeric rating used in this study is a non-validated metric.
Visit 2 will comprise dispensing of first randomly allocated study spectacles. Visual acuity will be measured, and quality of vision will be assessed via a numeric rating scale, with first study spectacles.
Visit 3 will comprise measurement of visual acuity and assessment of quality of vision via a numeric rating scale with first study spectacles. The first study spectacle lenses will be collected from the participant. The second study spectacles will be dispensed to the participant. Visual acuity will be measured, and quality of vision will be assessed via a numeric rating scale, with second study spectacles. There is no 'wash-out' period between treatments.
Visit 4 will comprise measurement of visual acuity and assessment of quality of vision via a numeric rating scale with second study spectacles. The second spectacle lenses will be collected at the completion of the visit.
All study spectacle lenses will be prescribed, and all assessments will be carried out by an optometrist.
Participants will be instructed to bring study spectacles to each visit. Compliance will be assessed by verbal questioning of the participant.
Intervention code [1] 317496 0
Treatment: Devices
Comparator / control treatment
Single vision spectacle lenses prescribed in traditional 0.25 D steps.
Control group
Active

Outcomes
Primary outcome [1] 323693 0
Participants will be asked to rate their quality of vision with each spectacle lens on a non-validated 1-100 numeric rating scale.
Timepoint [1] 323693 0
Visit 3: (approximately 3 weeks post-enrollment)
Visit 4: (approximately 4 weeks post-enrollment)
Secondary outcome [1] 382633 0
Visual acuity with each spectacle lens will be measured using standard Snellen charts at 6 m
Timepoint [1] 382633 0
Visit 3: (approximately 3 weeks post-enrollment)
Visit 4: (approximately 4 weeks post-enrollment)
Secondary outcome [2] 382634 0
Preference for first spectacle lens or second spectacle lens worn will be assessed via a non-validated questionnaire designed specifically for this study.
Timepoint [2] 382634 0
Visit 4: (approximately 4 weeks post-enrollment)

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Healthy adults aged 18 to 45 years of age (inclusive).
Willing to refrain from using soft contact lenses for the duration of the study.
Spherical refractive error between -1.00 and -6.00 D (inclusive) with cylinder power less than or equal to 1.00 D.
Can attain good vision: Best corrected visual acuity of 6/6 or better in each eye.
Willing to wear the study spectacles provided daily in lieu of their habitual spectacles for the duration of the study.
Willing to attend the scheduled study visits and adhere to instructions.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Be currently using topical ocular medication or have used topical ocular medication within 2 weeks of the first visit. Patients who are being treated bilaterally with marketed artificial tears can be considered, provided they discontinue use for 24 hours prior to each visit.
History of clinically significant or progressive ocular disease in either eye that would affect vision e.g. keratoconus.
Clinically significant anisometropia (difference in refractive power between the two eyes) of > 1.00D.
Rigid gas permeable lens wearer (including orthokeratology).
Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus.
History of eye surgery or eye trauma within 6 months prior to enrolment in the study.
History of corneal refractive surgery.
The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if 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)
Central randomisation by phone/fax/compute
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
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: A paired difference of 8 units on a numeric rating scale of 1-100 for subjective vision quality in 1-point steps is considered clinically meaningful. Assuming a standard deviation of +/- 18 units, a minimum of 50 participants is required to determine a statistically significant difference of 8 +/- 18 units at the 5% level of significance and 80% power. The sample size is adjusted for a 15% dropout rate.
Data will be summarised as means ± standard deviations for variables measured on an interval scale, median ± interquartile range for ordinal variables and percentages for those that are categorical.
Statistical tests will be employed to determine significant differences between the two spectacle lens corrections. Commonly used tests of significance at each visit may include paired t-tests and group t-test for parametric data and Wilcoxon sign rank test and rank sum test for non-parametric data. Categorical data may be analysed using the chi-squared test.

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] 305642 0
Commercial sector/Industry
Name [1] 305642 0
nthalmic Pty Ltd
Address [1] 305642 0
Suite L2 Level 3 Lakes Business Park
2A Lord Street
Botany NSW 2019
Country [1] 305642 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] 306048 0
None
Name [1] 306048 0
Not applicable
Address [1] 306048 0
Not applicable
Country [1] 306048 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305928 0
University of New South Wales HREC
Ethics committee address [1] 305928 0
The University of New South Wales

Sydney NSW 2052
Ethics committee country [1] 305928 0
Australia
Date submitted for ethics approval [1] 305928 0
19/05/2020
Approval date [1] 305928 0
Ethics approval number [1] 305928 0

Summary
Brief summary
The purpose of this trials is to assess the effect on visual performance when spectacles lenses are prescribed in 0.05 D steps compared to when they are prescribed in 0.25 D steps
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102098 0
Prof Fiona Stapleton
Address 102098 0
School of Optometry and Vision Science,
Rupert Myers Building North Wing,
Gate 14 Barker St.
UNSW Sydney NSW 2052
Country 102098 0
Australia
Phone 102098 0
+61 2 9385 4375
Fax 102098 0
Email 102098 0
f.stapleton@unsw.edu.au
Contact person for public queries
Name 102099 0
Dr Jacqueline Tan
Address 102099 0
School of Optometry and Vision Science,
Rupert Myers Building North Wing,
Gate 14 Barker St.
UNSW Sydney NSW 2052
Country 102099 0
Australia
Phone 102099 0
+61 2 9385 6551
Fax 102099 0
Email 102099 0
jacqueline.tan@unsw.edu.au
Contact person for scientific queries
Name 102100 0
Mr Daniel Tilia
Address 102100 0
nthalmic Pty Ltd.
Suite L2 Level 3 Lakes Business Park
2A Lord Street Botany NSW 2019

Country 102100 0
Australia
Phone 102100 0
+61 2 9695 1731
Fax 102100 0
Email 102100 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 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