Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000979752
Ethics application status
Approved
Date submitted
24/06/2022
Date registered
12/07/2022
Date last updated
12/07/2022
Date data sharing statement initially provided
12/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of pupil in myopia
Scientific title
Role of pupillary responses in myopia onset and progression
Secondary ID [1] 307428 0
Nil known
Universal Trial Number (UTN)
U1111-1279-7536
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 326783 0
Condition category
Condition code
Eye 324002 324002 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A commercially available, dynamic autorefractor (Grand Seiko WAM 5500) will be used to measure accommodation and pupillary responses. Participants will be seated in front of this instrument with their chin and forehead comfortably rested. Participants will be asked to look at the computer display placed at 50cms. Text in English language and mathematical problems will be presented on the computer screen. Participants will be asked to read the text material and calculate the solution for the mathematical problems. These tasks will be performed under the white and blue light illumination.

Once participant is seated comfortably, the examiner aligns the instrument and records the data by pressing the start button of the instrument. Accommodation and pupillary responses will be recorded using auto refractor. Measurements would be performed under normal binocular viewing and participants can blink normally while the measurement is in progress and regular breaks will be provided between the measurements.

All the measurements using autorefractor will be performed inserting a soft contact lens which is equivalent to the participants habitual refractive correction to get the accurate measurements from the instrument. Participants will be fitted with a soft contact lens for the duration of the study. A clean, sterile lens will be removed from the package and inserted on the eye. The lens will be inserted by research student (who has experience in fitting the contact lens) under the supervision of registered optometrist and participants will be required to wear the contact lens for approximately 45 minutes (for each type of lens). Once the study procedures are completed, the contact lens will be removed and discarded.

Participants have to attend three visits and the measurements will be done using commercially available daily disposable soft contact lenses, MiSight contact lenses from CooperVision Inc, and Miyo Smart spectacle lenses from Hoya corporation. Each session would take approximately 45 minutes only. Acuvue moist lenses are single vision contact lenses whereas MiSight contact lenses and Miyo Smart lenses are multifocal contact lenses and spectacles for myopia control from CooperVision Inc and Hoya corporation respectively. Wash out period between the sessions would be 24 hours.

Study Location: Brien Holden Vision Institute, University of New South Wales
Intervention code [1] 323866 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331798 0
Change in pupillary responses to blue light by Grand Seiko autorefractor using Acuvue moist soft contact lenses.
Timepoint [1] 331798 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Primary outcome [2] 331839 0
Change in pupillary responses to blue light by Grand Seiko autorefractor using MiSight contact lenses.
Timepoint [2] 331839 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Primary outcome [3] 331840 0
Change in pupillary responses to blue light by Grand Seiko autorefractor using Miyo Smart spectacle lenses.
Timepoint [3] 331840 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [1] 411349 0
Change in accommodative responses to blue light by Grand Seiko autorefractor using Acuvue moist soft contact lenses.
Timepoint [1] 411349 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [2] 411392 0
Change in accommodative responses to blue light by Grand Seiko autorefractor using MiSight contact lenses.
Timepoint [2] 411392 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [3] 411393 0
Change in accommodative responses to blue light by Grand Seiko autorefractor using Miyo Smart spectacle lenses.
Timepoint [3] 411393 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [4] 411631 0
Change in pupillary responses to white light by Grand Seiko autorefractor using Acuvue moist soft contact lenses.
Timepoint [4] 411631 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [5] 411632 0
Change in pupillary responses responses to white light by Grand Seiko autorefractor using Miyo Smart spectacle lenses.
Timepoint [5] 411632 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [6] 411633 0
Change in pupillary responses responses to white light by Grand Seiko autorefractor using MiSight contact lenses.
Timepoint [6] 411633 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [7] 411634 0
Change in accommodative responses to white light by Grand Seiko autorefractor using Acuvue moist soft contact lenses.
Timepoint [7] 411634 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [8] 411635 0
Change in accommodative responses to white light by Grand Seiko autorefractor using Miyo Smart spectacle lenses.
Timepoint [8] 411635 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)
Secondary outcome [9] 411636 0
Change in accommodative responses responses to white light by Grand Seiko autorefractor using MiSight contact lenses.
Timepoint [9] 411636 0
Baseline (before wearing myopia control lenses i.e., MiSight and Miyo Smart lenses) , 24 hours (session 2) , 48 hours (Session 3)

Eligibility
Key inclusion criteria
• Presence of myopia;
• Age between 18 - 35 years.
• No ocular disease or history of ocular injury.
• Normal systemic health and not on any medications which may influence ocular
health
• No prior refractive surgery;
• No ocular or systemic medications that may affect the pupillary response;
• No history of amblyopia (lazy eye) or strabismus (eye not looking straight)
• Able to read and comprehend English
• Willing to wear contact lens during the study: can be an experienced soft contact lens
wearer or no prior contact lens wear experience.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Eye diseases such as oculomotor nerve palsies, glaucoma, amblyopia and binocular
vision anomalies like nystagmus, strabismus which may affect the accommodation or
cognition.
• Aged 36 years or older and younger than 18 years
• Presence of astigmatism >1.00 DC
• History of any systemic diseases including diabetes, hypertension, cardiac problems
• History of any refractive or ocular surgeries
• History of any other ocular pathology
• Intra ocular pressure >/= 21 mm of Hg (which would be determined by research team
while screening).
• Ocular hypertension or glaucoma in either eye

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
15 myopes would be recruited in the study. Pupil size will be recorded in an interval scale and analyzed as a continuous variable. Normality of the outcome variable will be assessed using shapiro- wilk test and appropriate transformations will be done if there is significant departure from the normality. The independent factors, accommodation, cognition will be recorded as ranked or categorical variables. As all subjects will be exposed to each level of the independent factor, the effects of accommodation, and cognition on pupil size will be analysed using linear models or repeated measures of ANOVA, where the independent factors are within-Participant factors and subject random intercepts are factored to account for within Participant correlation. Interactions of factors will be tested. If interactions are significant then the post hoc univariate analysis will be performed within levels of other interacting factors. Post hoc multiple comparisons will be adjusted using Bonferroni correction. Statistical significance will be at 5%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37876 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 311702 0
Other
Name [1] 311702 0
Brien Holden Vision Institute
Country [1] 311702 0
Australia
Primary sponsor type
Individual
Name
Geetha Sravani
Address
Level 4 RMB Gate 14 Barker street UNSW Sydney NSW Australia 2052
Country
Australia
Secondary sponsor category [1] 313158 0
None
Name [1] 313158 0
Address [1] 313158 0
Country [1] 313158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311154 0
University of New South Wales Research Ethics Committee D
Ethics committee address [1] 311154 0
Ethics committee country [1] 311154 0
Australia
Date submitted for ethics approval [1] 311154 0
11/10/2021
Approval date [1] 311154 0
24/11/2021
Ethics approval number [1] 311154 0
HC210842

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

Contacts
Principal investigator
Name 120134 0
Miss Geetha Sravani
Address 120134 0
Brien Holden Vision Institute, University of New South Wales
level 4 RMB Barker Street UNSW Sydney NSW Australia 2052
Country 120134 0
Australia
Phone 120134 0
+61 422696895
Fax 120134 0
Email 120134 0
[email protected]
Contact person for public queries
Name 120135 0
Geetha Sravani
Address 120135 0
Brien Holden Vision Institute, University of New South Wales
level 4 RMB Barker Street UNSW Sydney NSW Australia 2052
Country 120135 0
Australia
Phone 120135 0
+61 422696895
Fax 120135 0
Email 120135 0
[email protected]
Contact person for scientific queries
Name 120136 0
Geetha Sravani
Address 120136 0
Brien Holden Vision Institute, University of New South Wales
level 4 RMB Barker Street UNSW Sydney NSW Australia 2052
Country 120136 0
Australia
Phone 120136 0
+61 422696895
Fax 120136 0
Email 120136 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
BHVI holds patents in Myopia control


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.