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Trial registered on ANZCTR


Registration number
ACTRN12622001269729
Ethics application status
Approved
Date submitted
31/08/2022
Date registered
26/09/2022
Date last updated
14/10/2022
Date data sharing statement initially provided
26/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of multifocal spectacle lenses on eye length and other ocular parameters in human.
Scientific title
Assessment of axial length and choroidal thickness changes in human eyes exposed to different types of multifocal spectacle lenses.
Secondary ID [1] 307859 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 327478 0
Condition category
Condition code
Eye 324603 324603 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a prospective, randomized, non-dispensing, short term wear (60 minutes) clinical trial. 20 healthy young adults with low to moderate myopia (-0.75D to -5.0D) will be enrolled. Participants will be asked to wear a 5 different types of multifocal spectacle lenses and one single vision spectacle lens over 6 days with a minimum of 24 hour of washout period between each lens wear. They will be asked to wear a spectacle frame fitted with a plano powered spectacle lens in one of the two eye frames and one of the randomly assigned multifocal spectacle lens in the other eye frame for 60 mins. Measurements of refractive error, axial length, choroidal thickness and contrast sensitivity will be measured before and after lens wear.

Lens descriptions:
Lens 1 is a single vision spectacle lens (control)
Lens 2 is a commercially available multifocal ophthalmic spectacle lens (control).
Lens 3 to 6 are prototype spectacle lenses, comprise of central zone for refractive error correction and a peripheral zone area comprising a refractive power that varies from central zone up to +/- 5.0D. Prototypes 3 and 4 will have central zone diameter of up to 9 mm whereas prototypes 5 and 6 will have central zone diameter of up to 5 mm.

This study will be conducted at Brien Holden Vision Institute Clinic and will be conducted and managed by student researcher with supervision by BHVI employed registered research optometrist and the study investigators. Student researcher is an optometrist by background with experience in study procedures including fitting of contact lenses and spectacles. He has also completed Good Clinical Practice training. Brien Holden Vision Institute has clinical facilities to conduct the study and access to relevant study population.

Each participant will have 6 visits including Screening/Baseline visit. (Screening/Baseline will take anywhere between 2-2.5 hour and each of the follow up visits will take approximately 1.5 hour). There will be a wash out period of a minimum of 24 hours between visits.

It is a non-dispensing, short term trial where participants will wear the lenses for 60 mins and stay in the clinic for the entire duration. Therefore, adherence to the strategy is monitored and recorded by the student researcher.
Intervention code [1] 324330 0
Treatment: Devices
Comparator / control treatment
Participants will be asked to wear a single vision plano lens fitted in a spectacle frame for 60 minutes in both eyes.
Control group
Active

Outcomes
Primary outcome [1] 332422 0
Changes in axial length of the eye will be assessed using an ocular biometer (LENSTAR LS900®, HAAG-STREIT, Switzerland). Participant will be seated with their chin resting on chin rest and forehead against a headrest. The participant will look into the red fixation target. No part of the instrument touches the eye during the procedure.
Timepoint [1] 332422 0
changes will be assessed after 60 minutes of lens wear for each prototype lens and a control lens.
Primary outcome [2] 332423 0
Changes in choroidal thickness will be assessed with a standard, commercially available Optical Coherence Tomography (DRI OCT™, TOPCON CORPORATION, Tokyo Japan) instrument. The participant will be seated for approximately 3 minutes with their chin in a chin-rest and forehead against a head-rest. The participant will look into the camera which will emit a fixation light. No part of the instrument touches the eye during the procedure.
Timepoint [2] 332423 0
changes will be assessed after 60 minutes of lens wear for each prototype lens and a control lens.
Secondary outcome [1] 413444 0
Changes in central and peripheral refractive error of the eye will be assessed together using a commercially available autorefractor (MVISION-K 5001, SHIN NIPPON, JAPAN) to determine refractive error. Participant will be seated with their chin resting on chin rest and forehead against a headrest. It momentarily projects an infrared target on the retina that is imaged and digitally analyzed to calculate the refractive error. No part of the instrument contacts the eye.
Timepoint [1] 413444 0
changes will be assessed after 60 minutes of lens wear for each prototype lens and a control lens.
Secondary outcome [2] 413445 0
Changes in contrast sensitivity function will be measured using targets projected on a screen using custom MATLAB code.
Timepoint [2] 413445 0
changes will be assessed after 60 minutes of lens wear for each prototype lens and a control lens.

Eligibility
Key inclusion criteria
• Non-cycloplegic spherical equivalent refractive error ranging from -0.75D to –5.00D
• Best corrected visual acuity of 20/30 or better in both eyes
• Normal ocular health (No ocular disease)
• No history of ocular surgery;
• No manifest squint or intermittent tropias;
• Astigmatism less than 1.50 D;
• Anisometropia of not more than 1.00 D;
• Absence of any ocular disease that might influence the trial outcomes- for example corneal or retinal disease, cataract and ptosis.
• Normal general health.
• No current use of ocular or systemic medications excepting use of lubricating or anti-allergic eye drops
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Use of rigid contact lens wear
• Any prior myopia control treatment
• Not willing to give consent; and
• Not willing to present for the required visit schedule

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)
The randomization plan will be generated by the data manager and applied through the Data Management system. The multifocal ophthalmic lenses will be coded with no identifiers of the type of lens and therefore the investigator and participants will remain masked during the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization plan will be generated from http://www.randomization.com/. The website uses the Wichman-Hill Random Number Generator, which will create balanced permutations of treatments where each participant receives all lens types in random order.
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome variable axial length will be measured in millimetre (mm), whereas refractive error and choroidal thickness will be measured in dioptres (D) and microns (µm) respectively on an interval scale. If test of normality is highly significant, then the raw data will either be log transformed or be analysed using non-parametric tests. Descriptive statistics will be used to summarise the data for all 6 visits. Paired t test, Wilcoxon sign rank test, repeated measures ANOVA and Kruskal-Wallis tests will be used for analysis. Pre vs Post lens wear data will be compared using paired t test or Wilcoxon sign rank test. The change in outcome variables defined as the difference between Post and Pre lens wear will be compared between the lens types using repeated measures ANOVA or Kruskal-Wallis test, where repeated lens visits will be factored as within-subject factors. Post-hoc multiple comparisons between lens visits will be corrected using Bonferroni correction. Secondary outcome variables: Contrast sensitivity function, will also be analysed similar to primary outcome.
Individual data points that are missing will be excluded from analysis involving only those specific variables based on a list wise missing procedure assuming individual data points are missing at random. Two-tailed distributions will be used for inferential statistics. Level of significance will be set at 5%. Any post hoc multiple comparisons will be adjusted using Bonferroni correction to ensure the family wise error rate is set at 5%. Data will be analysed using IBM SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/11/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 38374 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 312137 0
Other Collaborative groups
Name [1] 312137 0
Brien Holden Vision Institute, Sydney
Country [1] 312137 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brien Holden Vision Institute
Address
Level5, North Wing, Rupert Myers Building, Gate 14, Barker Street, UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 313659 0
None
Name [1] 313659 0
Address [1] 313659 0
Country [1] 313659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311531 0
UNSW Human Ethics Committee
Ethics committee address [1] 311531 0
Ethics committee country [1] 311531 0
Australia
Date submitted for ethics approval [1] 311531 0
20/07/2022
Approval date [1] 311531 0
11/10/2022
Ethics approval number [1] 311531 0
HC220486

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

Contacts
Principal investigator
Name 121430 0
Prof Padmaja Sankaridurg
Address 121430 0
Brien Holden Vision Institute, Level 4, North Wing, Rupert Myers Building, Gate 14, Barker street, UNSW Sydney, NSW 2052
Country 121430 0
Australia
Phone 121430 0
+61 407893613
Fax 121430 0
Email 121430 0
p.sankaridurg@bhvi.org
Contact person for public queries
Name 121431 0
Zeeshan Akhtar
Address 121431 0
Brien Holden Vision Institute, Level 4, North Wing, Rupert Myers Building, Gate 14, Barker street, UNSW Sydney, NSW 2052
Country 121431 0
Australia
Phone 121431 0
+61 431262181
Fax 121431 0
Email 121431 0
z.akhtar@unsw.edu.au
Contact person for scientific queries
Name 121432 0
Padmaja Sankaridurg
Address 121432 0
Brien Holden Vision Institute, Level 4, North Wing, Rupert Myers Building, Gate 14, Barker street, UNSW Sydney, NSW 2052
Country 121432 0
Australia
Phone 121432 0
+61 290650700
Fax 121432 0
Email 121432 0
p.sankaridurg@bhvi.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.