Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001375741
Ethics application status
Approved
Date submitted
21/10/2022
Date registered
26/10/2022
Date last updated
26/10/2022
Date data sharing statement initially provided
26/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of multifocal contact lens (MFCL) and combined therapy of MFCL and atropine on the eye-related functions among adult myopes.
Scientific title
Characteristic Changes of Visual Functions using Multifocal Contact Lenses in Adult Myopes.
Secondary ID [1] 308257 0
"Nil known"
Universal Trial Number (UTN)
U1111-1283-8084
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressive myopia 327897 0
Condition category
Condition code
Eye 324984 324984 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study contains two phases:
Phase one involves fitting one eye with a daily disposable soft multifocal contact lens. After 20 minutes of lens insertion, measurements will be taken.

In the same visit, phase two, one drop of 0.05% of atropine sulfate eye drops will be applied in the same eye wearing contact lenses, taken just once, as one drop in only one eye. The study measurements will be retaken after 30 minutes of eye drop instillation. This visit will take approximately 1 hour and 22 minutes.

The contact lenses will be removed at the end of phase 2 (after all measurements are completed). Afterward, the participant’s ocular surface will be assessed using a microscopic slit lamp to rule out any possible complications.

Treatment device
MiSight 1 Day contact lenses prescribed by a registered optometrist to participants with myopia will be worn in one eye for a maximum of 2 hours during the study visit.

Treatment Drug
0.05% atropine sulfate eye drops, taken just once, as one drop in one eye.

All procedures including drop instillation will be conducted at the School of Optometry and Vision Science, UNSW, and be administered by a Ph.D. candidate under the supervision of Australian registered optometrists.”

The study's investigators will only insert the contact lens and install the eye drop during the study visit, so no adherence measurements are required.
Intervention code [1] 324623 0
Treatment: Devices
Intervention code [2] 324658 0
Treatment: Drugs
Comparator / control treatment
Each participant will serve as their own control, as the same measurements will be taken before and after the intervention.
Control group
Active

Outcomes
Primary outcome [1] 332786 0
Changes in colour contrast sensitivity functions. Measurements of the right eye will be captured using a custom computer-based program in MATLAB.
Timepoint [1] 332786 0
Visit 2: Measurements will be taken 20 minutes after contact lens insertion and will be taken again 30 minutes after the eye drop is applied.
Primary outcome [2] 332787 0
Changes in contrast sensitivity functions. Measurements of the right eye will be captured using a custom computer-based program in MATLAB.
Timepoint [2] 332787 0
Visit 2: Measurements will be taken 20 minutes after contact lens insertion and will be taken again 30 minutes after the eye drop is applied.
Primary outcome [3] 332788 0
Changes in detect motion sensitivity functions. Measurements of the right eye will be captured using a custom computer-based program in MATLAB.
Timepoint [3] 332788 0
Visit 2: Measurements will be taken 20 minutes after contact lens insertion and will be taken again 30 minutes after the eye drop is applied.
Secondary outcome [1] 414711 0
Mean changes in peripheral refractive errors measured by Autorefractor (NVision K-5001; Shin-Nippon, Tokyo, Japan). Measurements of the right eye will be captured at the center, nasal (10,20,30 degrees), and temporal ( 10, 20, 30 degrees) visual fields.
Timepoint [1] 414711 0
Visit 2: Measurements will be taken 20 minutes after contact lens insertion and will be taken again 30 minutes after the eye drop is applied.
Secondary outcome [2] 414712 0
Changes in pupil size before and after the intervention measured by Neuroptics PLR-3000 pupilometer for both eyes.
Timepoint [2] 414712 0
Visit 2: Measurements will be taken 20 minutes after contact lens insertion and will be taken again 30 minutes after the eye drop is applied.
Secondary outcome [3] 414713 0
The optical quality of the ocular surface. Measurements of the right eye will be captured using Topcon KR-1W.
Timepoint [3] 414713 0
Visit 2: Measurements will be taken 20 minutes after contact lens insertion and will be taken again 30 minutes after the eye drop is applied.

Eligibility
Key inclusion criteria
• Aged 18-35 years-old with good general health.
• An experienced soft contact lens wearer or willing to wear soft contact lenses.
• Have a prescription between -0.50 and -4.00D, with less than -1.50D of astigmatism.
• Have good ocular health.
• Have a ‘normal’ vision, measuring 6/7.5 or better with correction.
• Have a normal colour vision
• Are willing to attend two study visits.
• Have a normal intraocular pressure
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Fitted with rigid gas permeable (RGP) lenses, bifocal or orthokeratology (OK) lenses within 4 weeks prior to study enrolment.
• Any eye diseases including inflammation, infection or allergy.
• Previous eye surgery within the last 6 months.
• Moderate to severe dryness or any disease might affect ocular surface integrity such as Pteryguim.
• Using ocular medications or eye drops.
• Any other condition which would prevent contact lens wear.


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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minimum total sample sizes were determined using PASS 2020 Power Analysis and Sample Size Software (2020). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass based on a repeated-measures analysis of variance with 0 between factor and 1 within factor has 1 group with 15 subjects each for a total of 15 subjects. Each subject is measured 2 times. This design achieves 80% power to test factor W1 if a Geisser-Greenhouse Corrected F Test is used with a 5% significance level and the actual effect standard deviation is 0.330 (an effect size of 0.7).
Data will be analysed using Excel and SPSS statistical packages. Overall changes in visual function variables will be analysed using ANOVA and post-hoc t-tests. Relationships between variables will be investigated using regression techniques. A critical p-value of 0.05 will be used to denote statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
10/02/2023
Actual
Date of last data collection
Anticipated
10/02/2023
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23367 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 38748 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 312431 0
University
Name [1] 312431 0
Unversity of New South Wales -UNSW
Country [1] 312431 0
Australia
Primary sponsor type
University
Name
Unversity of New South Wales -UNSW
Address
UNSW Sydney
High St
Kensington NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 314007 0
None
Name [1] 314007 0
None
Address [1] 314007 0
NA
Country [1] 314007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311778 0
The HREA Panel G: Health, Medical, Community & Social
Ethics committee address [1] 311778 0
Health Human Research Ethics Committees (HRECs)
UNSW Sydney NSW 2052
Australia
Ethics committee country [1] 311778 0
Australia
Date submitted for ethics approval [1] 311778 0
25/05/2022
Approval date [1] 311778 0
06/06/2022
Ethics approval number [1] 311778 0
HC200100

Summary
Brief summary
Multifocal contact lenses (MFCLs) have shown promising results in slowing myopia progression in children. However, the underlying mechanism for treating myopia with MFCLs is still uncertain; it is assumed that MFCLs reduce hyperopic defocus in the periphery, inhibit accommodation lag, and improve the amplitude of accommodation in myopes. It has been demonstrated that myopic blur induced by the peripheral portions of these lenses can reduce myopia progression in children by 36.4% and axial elongation by 37.9%.
However, the effect of MFCL on the ability of the eye to detect the stimulus properties such as contrast, colour, and motion remains unknown, and it is possible that MFCL impact these functions, which may contribute to its effect in slowing myopia progression. It is assumed that both optical and pharmaceutical treatments use two different mechanisms to reduce myopia progression and combining both interventions (known as combined therapy) may provide better myopia control than one treatment alone (monotherapy).
The primary objective of this study is to examine the effects of MFCL alone (monotherapy) and its combination with 0.05 % atropine sulfate eye drops (combined therapy) on a range of basic visual functions (contrast sensitivity, colour, and motion detection), pupil size, and image quality. This research is expected to provide a greater understanding of the effect of MFCL on the blur detection mechanism of the eye and associated visual function changes and the potential mechanisms underlying myopia development and progression. To achieve this, the outcome measurements will be taken twice, first with MiSight contact lenses and then with 0.05 % atropine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122330 0
A/Prof Sieu Khuu
Address 122330 0
University of New South Wales (UNSW)
Faculty of Medicine and Health
School of Optometry and Vision Science
Level 3, Room 3.028
Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 122330 0
Australia
Phone 122330 0
+61 2 9385 4620
Fax 122330 0
Email 122330 0
s.khuu@unsw.edu.au
Contact person for public queries
Name 122331 0
A/Prof Sieu Khuu
Address 122331 0
University of New South Wales (UNSW)
Faculty of Medicine and Health
School of Optometry and Vision Science
Level 3, Room 3.028
Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 122331 0
Australia
Phone 122331 0
+61 2 9385 4620
Fax 122331 0
Email 122331 0
s.khuu@unsw.edu.au
Contact person for scientific queries
Name 122332 0
A/Prof Sieu Khuu
Address 122332 0
University of New South Wales (UNSW)
Faculty of Medicine and Health
School of Optometry and Vision Science
Level 3, Room 3.028
Rupert Myers Building (M15), Southern Dr, UNSW, Kensington NSW 2052
Country 122332 0
Australia
Phone 122332 0
+61 2 9385 4620
Fax 122332 0
Email 122332 0
s.khuu@unsw.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17348Informed consent form    384818-(Uploaded-12-10-2022-17-43-43)-Study-related document.pdf
17349Ethical approval    384818-(Uploaded-12-10-2022-17-45-03)-Study-related document.Pdf



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.